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PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. CAUSES AND REMEDIES OF LAMINATION IN TABLET MANUFACTURING An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. SOP FOR WASHING OF HPLC COLUMNS : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
TYPES OF AIRLOCKS AND REQUIREMENT IN PHARMACEUTICAL Airlocks are closed rooms having two or more doors between two different controlled areas having different cleanliness levels as class B and class C, class C and class D areas. These airlocks prevent the direct airflow between these areas during the entry of material orpersonnel.
5 MAJOR DIFFERENCE BETWEEN RO AND EDI WATER SYSTEMS Water is the heart of the human body, 50-65 % on average, although when looking at infants the percentage is typically around 75-78%. Water intake is mostly recommended since most body processes require it to facilitate optimal body functioning. DIFFERENCE BETWEEN INJECTION AND INFUSION : PHARMACEUTICAL Both injection and infusion are medical terminologies. They are both ways of administering medicine to a patient and important in health and life-saving. The medicine is usually in liquid form. Many people are usually confused and do not know their differences. PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatoryagencies.
PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. CAUSES AND REMEDIES OF LAMINATION IN TABLET MANUFACTURING An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. SOP FOR WASHING OF HPLC COLUMNS : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
TYPES OF AIRLOCKS AND REQUIREMENT IN PHARMACEUTICAL Airlocks are closed rooms having two or more doors between two different controlled areas having different cleanliness levels as class B and class C, class C and class D areas. These airlocks prevent the direct airflow between these areas during the entry of material orpersonnel.
5 MAJOR DIFFERENCE BETWEEN RO AND EDI WATER SYSTEMS Water is the heart of the human body, 50-65 % on average, although when looking at infants the percentage is typically around 75-78%. Water intake is mostly recommended since most body processes require it to facilitate optimal body functioning. DIFFERENCE BETWEEN INJECTION AND INFUSION : PHARMACEUTICAL Both injection and infusion are medical terminologies. They are both ways of administering medicine to a patient and important in health and life-saving. The medicine is usually in liquid form. Many people are usually confused and do not know their differences. FAULT TREE ANALYSIS FOR INVESTIGATION : PHARMACEUTICAL Fault Tree Analysis for Investigation You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry. SOP FOR PROCESS VALIDATION : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE The purpose of this SOP is to lay down the minimum requirements for validation or revalidation of manufacturing processes applicable to marketed drug products in order to provide documented evidence that each specific process will consistently yield a product meeting all quality and design specifications. SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. POSSIBLE CAUSES OF OUT OF SPECIFICATION : PHARMACEUTICAL Out of specification results are not rare in pharmaceutical industries but their investigation and finding the real root cause is time consuming process. Their investigation process includes many steps. SOP FOR FIRST AID : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE To lay down the procedure to render immediate first aid in an emergency to preserve life and assist recovery. 2.0 SCOPE This procedure is applicable for a casualty for any injury or sudden illness before the arrival of a qualified medical expert. SOP FOR WASHING OF HPLC COLUMNS : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CONCEPT OF GXP IN PHARMACEUTICALS : PHARMACEUTICAL GUIDELINES So what is the main purpose of GxP? In simple terms, it is a set of guidelines in place to ensure that products and services are safe. To elaborate on this point, GxP enforces regulated industries to stick to very specific and secure manufacturing processes and storage procedures, ensures safe clinical trials involving human subjects and also establishes effective research standards for non FACTORY ACCEPTANCE TEST Factory acceptance test FAT is important for equipment because It helps to identify the problems with the equipment and correct themprior to shipping.
DIFFERENCE BETWEEN INJECTION AND INFUSION : PHARMACEUTICAL Both injection and infusion are medical terminologies. They are both ways of administering medicine to a patient and important in health and life-saving. The medicine is usually in liquid form. Many people are usually confused and do not know their differences. RELATIVE RESPONSE FACTOR (RRF) AND ITS CALCULATION IN HPLC Relative Response Factor (full form of RRF) is an alternate method for the determination of the quantity of the impurities present in pharmaceutical products and amount of the impurity can be calculated with the help of peak area of the components. PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOPS FOR STORES/ WAREHOUSE : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for stores/ warehouse department in pharmaceutical manufacturing plant. SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. GAP ANALYSIS FOR REGULATORY COMPLIANCE : PHARMACEUTICAL If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis. Gap analysis should be done for all SOPs, validation procedures and other activities to find out the possibilities ofimprovement.
SOP FOR DISINFECTANT EFFICACY TEST : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR SAMPLING AND TESTING OF PURE STEAM 1.0 PURPOSE To lay down the procedure for the sampling of Pure steam for Microbiological and Chemical analysis. 2.0 SCOPE It is applicable to Microbiology Laboratory SOP FOR OPERATION AND MAINTENANCE OF FOGGER Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOPS FOR STORES/ WAREHOUSE : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for stores/ warehouse department in pharmaceutical manufacturing plant. SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. GAP ANALYSIS FOR REGULATORY COMPLIANCE : PHARMACEUTICAL If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis. Gap analysis should be done for all SOPs, validation procedures and other activities to find out the possibilities ofimprovement.
SOP FOR DISINFECTANT EFFICACY TEST : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR SAMPLING AND TESTING OF PURE STEAM 1.0 PURPOSE To lay down the procedure for the sampling of Pure steam for Microbiological and Chemical analysis. 2.0 SCOPE It is applicable to Microbiology Laboratory SOP FOR OPERATION AND MAINTENANCE OF FOGGER Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask COVID-19 SOP FOR HOME : PHARMACEUTICAL GUIDELINES 1.0 Objective: To lay down the procedure for prevention from COVID-19 at home. 2.0 Scope: This procedure is applicable to the home of everyone. 3.0 Responsibility: Every member of the home. 4.0 Accountability: Housewife in the home. 5.0 Procedure: 5.1 Visits to the Market 5.1.1 Always wear a triple layer /N95 nose mask or use face cover when you go out of your home. PHARMA SOPS : PHARMACEUTICAL GUIDELINES Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
FAULT TREE ANALYSIS FOR INVESTIGATION : PHARMACEUTICAL Fault Tree Analysis for Investigation You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry. SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. SOP FOR FINGER DAB : PHARMACEUTICAL GUIDELINES QC Manager 5.0 Procedure 5.1 Equipment Required 5.1.1 Sterile dress 5.1.2 Clean SS container 5.2 Material Required 5.2.1 Sterile SCDA plates 5.2.2 Sterile 70% IPA solution STERILITY VALIDATION (MEMBRANE FILTRATION METHOD) IN Acceptance Criteria 1. If the conspicuous growth is observed within 3 days for bacteria and 5 days for fungi, and the growth of each challenge microorganisms in the Positive Product control containers are visually comparable to the growth in the positive control and there is no growth in negative control & negative product control, the product possess no antimicrobial activity under the CAUSES AND REMEDIES OF LAMINATION IN TABLET MANUFACTURING An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. SOP FOR HANDLING OF OUT OF SPECIFICATION RESULTS IN 1.0 PURPOSE To lay down the procedure for handling of out of specification results in microbiological testing. 2.0 SCOPE It is applicable to handling and investigation of Out Of Specification results in Sterility Test, Microbiological Testing of Non-Sterile Products and Bacterial Endotoxin Tests in Quality Control MicrobiologyLaboratory.
SOP FOR CLEANING OF DEHUMIDIFIER : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOPS FOR STORES/ WAREHOUSE : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for stores/ warehouse department in pharmaceutical manufacturing plant. SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. SOP FOR DISINFECTANT EFFICACY TEST : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR SAMPLING AND TESTING OF PURE STEAM 1.0 PURPOSE To lay down the procedure for the sampling of Pure steam for Microbiological and Chemical analysis. 2.0 SCOPE It is applicable to Microbiology Laboratory STERILITY VALIDATION (MEMBRANE FILTRATION METHOD) IN Acceptance Criteria 1. If the conspicuous growth is observed within 3 days for bacteria and 5 days for fungi, and the growth of each challenge microorganisms in the Positive Product control containers are visually comparable to the growth in the positive control and there is no growth in negative control & negative product control, the product possess no antimicrobial activity under the SOP FOR OPERATION AND MAINTENANCE OF FOGGER Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOPS FOR STORES/ WAREHOUSE : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for stores/ warehouse department in pharmaceutical manufacturing plant. SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. SOP FOR DISINFECTANT EFFICACY TEST : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR SAMPLING AND TESTING OF PURE STEAM 1.0 PURPOSE To lay down the procedure for the sampling of Pure steam for Microbiological and Chemical analysis. 2.0 SCOPE It is applicable to Microbiology Laboratory STERILITY VALIDATION (MEMBRANE FILTRATION METHOD) IN Acceptance Criteria 1. If the conspicuous growth is observed within 3 days for bacteria and 5 days for fungi, and the growth of each challenge microorganisms in the Positive Product control containers are visually comparable to the growth in the positive control and there is no growth in negative control & negative product control, the product possess no antimicrobial activity under the SOP FOR OPERATION AND MAINTENANCE OF FOGGER Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask COVID-19 SOP FOR HOME : PHARMACEUTICAL GUIDELINES 1.0 Objective: To lay down the procedure for prevention from COVID-19 at home. 2.0 Scope: This procedure is applicable to the home of everyone. 3.0 Responsibility: Every member of the home. 4.0 Accountability: Housewife in the home. 5.0 Procedure: 5.1 Visits to the Market 5.1.1 Always wear a triple layer /N95 nose mask or use face cover when you go out of your home. PHARMA SOPS : PHARMACEUTICAL GUIDELINES Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
FAULT TREE ANALYSIS FOR INVESTIGATION : PHARMACEUTICAL Fault Tree Analysis for Investigation You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry. SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. CHECKLIST FOR AUDIT IN QUALITY CONTROL : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask SOP FOR FINGER DAB : PHARMACEUTICAL GUIDELINES QC Manager 5.0 Procedure 5.1 Equipment Required 5.1.1 Sterile dress 5.1.2 Clean SS container 5.2 Material Required 5.2.1 Sterile SCDA plates 5.2.2 Sterile 70% IPA solution CAUSES AND REMEDIES OF LAMINATION IN TABLET MANUFACTURING An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. SOP FOR HANDLING OF OUT OF SPECIFICATION RESULTS IN 1.0 PURPOSE To lay down the procedure for handling of out of specification results in microbiological testing. 2.0 SCOPE It is applicable to handling and investigation of Out Of Specification results in Sterility Test, Microbiological Testing of Non-Sterile Products and Bacterial Endotoxin Tests in Quality Control MicrobiologyLaboratory.
SOP FOR CALIBRATION OF BROOK FIELD VISCOMETER Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatoryagencies.
SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. FAULT TREE ANALYSIS FOR INVESTIGATION : PHARMACEUTICAL Fault Tree Analysis for Investigation You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry. SOP FOR PROCESS VALIDATION : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE The purpose of this SOP is to lay down the minimum requirements for validation or revalidation of manufacturing processes applicable to marketed drug products in order to provide documented evidence that each specific process will consistently yield a product meeting all quality and design specifications. SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. SOP FOR FIRST AID : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE To lay down the procedure to render immediate first aid in an emergency to preserve life and assist recovery. 2.0 SCOPE This procedure is applicable for a casualty for any injury or sudden illness before the arrival of a qualified medical expert. OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR WASHING OF HPLC COLUMNS : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
DIFFERENCE BETWEEN INJECTION AND INFUSION : PHARMACEUTICAL Both injection and infusion are medical terminologies. They are both ways of administering medicine to a patient and important in health and life-saving. The medicine is usually in liquid form. Many people are usually confused and do not know their differences. PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatoryagencies.
SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. FAULT TREE ANALYSIS FOR INVESTIGATION : PHARMACEUTICAL Fault Tree Analysis for Investigation You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry. SOP FOR PROCESS VALIDATION : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE The purpose of this SOP is to lay down the minimum requirements for validation or revalidation of manufacturing processes applicable to marketed drug products in order to provide documented evidence that each specific process will consistently yield a product meeting all quality and design specifications. SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. SOP FOR FIRST AID : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE To lay down the procedure to render immediate first aid in an emergency to preserve life and assist recovery. 2.0 SCOPE This procedure is applicable for a casualty for any injury or sudden illness before the arrival of a qualified medical expert. OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR WASHING OF HPLC COLUMNS : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
DIFFERENCE BETWEEN INJECTION AND INFUSION : PHARMACEUTICAL Both injection and infusion are medical terminologies. They are both ways of administering medicine to a patient and important in health and life-saving. The medicine is usually in liquid form. Many people are usually confused and do not know their differences. SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. POSSIBLE CAUSES OF OUT OF SPECIFICATION : PHARMACEUTICAL Out of specification results are not rare in pharmaceutical industries but their investigation and finding the real root cause is time consuming process. Their investigation process includes many steps. FUNCTIONS OF QUALITY ASSURANCE : PHARMACEUTICAL GUIDELINES Quality assurance is an important part of pharmaceutical manufacturing. It assures the quality of the products those are manufactured in manufacturing facility. It is thought that documentation is the main function of quality assurance but it also controls the manufacturing system to RODAC PLATES AND THEIR USE IN PHARMACEUTICALS RODAC is an abbreviation of Replicate Organism Detection and Counting. It is usually used for surface sample testing. It is an agar, poured in a contact plate and SOP FOR WASHING OF HPLC COLUMNS : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask SOP FOR STARTING AND STOPPING OF BOILERS : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask STERILITY VALIDATION (MEMBRANE FILTRATION METHOD) IN Acceptance Criteria 1. If the conspicuous growth is observed within 3 days for bacteria and 5 days for fungi, and the growth of each challenge microorganisms in the Positive Product control containers are visually comparable to the growth in the positive control and there is no growth in negative control & negative product control, the product possess no antimicrobial activity under the METHOD OF ANALYSIS FOR SODIUM HYDROXIDE : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask RELATIVE RESPONSE FACTOR (RRF) AND ITS CALCULATION IN HPLC Relative Response Factor (full form of RRF) is an alternate method for the determination of the quantity of the impurities present in pharmaceutical products and amount of the impurity can be calculated with the help of peak area of the components. DIFFERENCE BETWEEN RECALL AND MOCK RECALL : PHARMACEUTICAL Difference between Recall and Mock Recall Recall and mock recall procedures for pharmaceuticals are different from each other. One is used to get back the marketed PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. FAULT TREE ANALYSIS FOR INVESTIGATION : PHARMACEUTICAL Fault Tree Analysis for Investigation You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry. SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. SOP FOR PROCESS VALIDATION : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE The purpose of this SOP is to lay down the minimum requirements for validation or revalidation of manufacturing processes applicable to marketed drug products in order to provide documented evidence that each specific process will consistently yield a product meeting all quality and design specifications. SOP FOR GOOD LABORATORY PRACTICE (GLP) : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask ROLE OF REGULATORY AFFAIRS IN PHARMACEUTICALS Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. They assess and perform quality checks to ensure that the medicinal drugs, veterinary drugs, and nutritional supplements rolled out by the pharmaceutical industry are safe and effective for the consumers to use. OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. QUALIFICATION PROCEDURE FOR VIAL WASHING MACHINE Procedure: About 3000 vials of the selected size are loaded on the feed belt and vial washing machine is operated as per the standard operating procedure. Place the spiked vials marked with permanent marker in between the other vials while the machine is running. These vials should be placed at the initial, middle and end of the washingsession.
TEMPERATURE AND HUMIDITY VALIDATION/MAPPING IN STORAGE Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at a higher temperature, therefore, it important to validate the storage area for temperature. PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. FAULT TREE ANALYSIS FOR INVESTIGATION : PHARMACEUTICAL Fault Tree Analysis for Investigation You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry. SOP FOR ACCEPTABLE QUALITY LEVEL (AQL) : PHARMACEUTICAL 5.5.1 If the no. of major /minor reject is at higher side. 5.5.2 If the results of AQL does not comply with the accept level. 5.6 If the cumulative total of a different defective sample in critical / major / minor category exceeds the stated ‘accept’ level, follow instruction 5.5 and again carry out AQL test as per procedure. SOP FOR PROCESS VALIDATION : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE The purpose of this SOP is to lay down the minimum requirements for validation or revalidation of manufacturing processes applicable to marketed drug products in order to provide documented evidence that each specific process will consistently yield a product meeting all quality and design specifications. SOP FOR GOOD LABORATORY PRACTICE (GLP) : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask ROLE OF REGULATORY AFFAIRS IN PHARMACEUTICALS Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. They assess and perform quality checks to ensure that the medicinal drugs, veterinary drugs, and nutritional supplements rolled out by the pharmaceutical industry are safe and effective for the consumers to use. OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. QUALIFICATION PROCEDURE FOR VIAL WASHING MACHINE Procedure: About 3000 vials of the selected size are loaded on the feed belt and vial washing machine is operated as per the standard operating procedure. Place the spiked vials marked with permanent marker in between the other vials while the machine is running. These vials should be placed at the initial, middle and end of the washingsession.
TEMPERATURE AND HUMIDITY VALIDATION/MAPPING IN STORAGE Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at a higher temperature, therefore, it important to validate the storage area for temperature. SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. SOP FOR GOOD LABORATORY PRACTICE (GLP) : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. SOP FOR FIRST AID : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE To lay down the procedure to render immediate first aid in an emergency to preserve life and assist recovery. 2.0 SCOPE This procedure is applicable for a casualty for any injury or sudden illness before the arrival of a qualified medical expert. ROLE OF REGULATORY AFFAIRS IN PHARMACEUTICALS Regulatory affairs in pharmaceuticals are like vehicle inspectors in the automotive industry. They assess and perform quality checks to ensure that the medicinal drugs, veterinary drugs, and nutritional supplements rolled out by the pharmaceutical industry are safe and effective for the consumers to use. SOP FOR STARTING AND STOPPING OF BOILERS : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CAUSES AND REMEDIES OF LAMINATION IN TABLET MANUFACTURING An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. SOP FOR SAMPLING AND TESTING OF PURE STEAM 1.0 PURPOSE To lay down the procedure for the sampling of Pure steam for Microbiological and Chemical analysis. 2.0 SCOPE It is applicable to Microbiology Laboratory SOP FOR OPERATION AND MAINTENANCE OF FOGGER Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask METHOD OF ANALYSIS FOR SODIUM HYDROXIDE : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatoryagencies.
PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOPS FOR STORES/ WAREHOUSE : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for stores/ warehouse department in pharmaceutical manufacturing plant. SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. ABOUT ANKUR CHOUDHARY : PHARMACEUTICAL GUIDELINES Ankur Choudhary is a professional pharmaceutical blogger from India having rich experience in the pharmaceutical field. After completion of his Masters of Science in Microbiology in 2002 from Gurukul Kangri University, he started his job in the pharmaceutical industry. GOOD DOCUMENTATION PRACTICES (GDP) These are the articles on good documentation practices in a pharmaceutical manufacturing facility, those are helpful to new as well as experienced pharmaceutical professionals SOP FOR DISINFECTANT EFFICACY TEST : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR PASSWORD POLICY AND DATA BACKUP AND STORAGE FOR 5.3.1 Yearly Backup: Upon completion of the year, analytical data of previous year shall be backed-up from IT server in pre-numbered tape in duplicate, Head IT shall be the custodian for the backup tapes. 5.3.1.1 Tolerance of the yearly backup data shall be ten working days after due date of yearly back-up. 5.3.1.2 Necessary entry shall be made in the yearly backup register. CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
PHARMACEUTICAL GUIDELINES : TOTAL PHARMACEUTICAL SOLUTIONSOPSQUALITY CONTROLQUALITY ASSURANCEMICROBIOLOGYPRODUCTIONVALIDATION A blog about pharmaceutical quality control, quality assurance, microbiology, production and regulatory updates provided by regulatoryagencies.
PHARMA SOPS : PHARMACEUTICAL GUIDELINESPRODUCTIONDOCUMENTSSOPS FOR QUALITY CONTROLABOUT ANKUR CHOUDHARY Standard Operating Procedures (SOPs) is a written procedure for any process or system that is followed during the operation of any systemor equipment.
SOPS FOR STORES/ WAREHOUSE : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for stores/ warehouse department in pharmaceutical manufacturing plant. SOPS FOR MICROBIOLOGY : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for microbiology department (sterile and non-sterile) in pharmaceutical products manufacturing facility. ABOUT ANKUR CHOUDHARY : PHARMACEUTICAL GUIDELINES Ankur Choudhary is a professional pharmaceutical blogger from India having rich experience in the pharmaceutical field. After completion of his Masters of Science in Microbiology in 2002 from Gurukul Kangri University, he started his job in the pharmaceutical industry. GOOD DOCUMENTATION PRACTICES (GDP) These are the articles on good documentation practices in a pharmaceutical manufacturing facility, those are helpful to new as well as experienced pharmaceutical professionals SOP FOR DISINFECTANT EFFICACY TEST : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask OCCUPATIONAL EXPOSURE BANDS (OEBS) FOR CHEMICALS Occupational exposure bands are measures put in place to categorize chemicals so that the health of the worker is not compromised. This is because Active Pharmaceutical Ingredients can have serious and adverse effects on the worker when they become lowly airborne. SOP FOR PASSWORD POLICY AND DATA BACKUP AND STORAGE FOR 5.3.1 Yearly Backup: Upon completion of the year, analytical data of previous year shall be backed-up from IT server in pre-numbered tape in duplicate, Head IT shall be the custodian for the backup tapes. 5.3.1.1 Tolerance of the yearly backup data shall be ten working days after due date of yearly back-up. 5.3.1.2 Necessary entry shall be made in the yearly backup register. CLIMATIC ZONES FOR STABILITY STUDIES : PHARMACEUTICAL The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into fivedifferent zones.
COVID-19 SOP FOR HOME : PHARMACEUTICAL GUIDELINES 1.0 Objective: To lay down the procedure for prevention from COVID-19 at home. 2.0 Scope: This procedure is applicable to the home of everyone. 3.0 Responsibility: Every member of the home. 4.0 Accountability: Housewife in the home. 5.0 Procedure: 5.1 Visits to the Market 5.1.1 Always wear a triple layer /N95 nose mask or use face cover when you go out of your home. SOPS FOR QUALITY CONTROL : PHARMACEUTICAL GUIDELINES List of Standard Operating Procedures (SOPs) for Quality Control laboratories in pharmaceutical products manufacturing facilities. SOP FOR DATA INTEGRITY : PHARMACEUTICAL GUIDELINES Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask CHECKLIST FOR AUDIT IN QUALITY CONTROL : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask SOP FOR WATER BATH : PHARMACEUTICAL GUIDELINES 1.0 OBJECTIVE To describe the procedure for Operation and calibration of the water bath. 2.0 SCOPE This SOP is applicable for Operation and calibration of the water bath. SOP FOR PERSONNEL GOWNING QUALIFICATION : PHARMACEUTICAL 5.3.1.1 Personal Monitoring by Contact plate (RODAC) technique. The Personnel shall enter in the aseptic area along with the microbiologist; Personnel and Microbiologist shall enter into the aseptic area as per current SOP of entry and exit to the Microbiology and Production area. CHECKLIST FOR AUDIT IN WAREHOUSE : PHARMACEUTICAL GUIDELINES Checklist to prepare for audit in warehouse/ stores. 1. Whether the storage area is adequately designed for better storage conditions? (i.e. temperature, light, humidity & cleanliness). CAUSES AND REMEDIES OF LAMINATION IN TABLET MANUFACTURING An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. METHOD OF ANALYSIS FOR ASCORBIC ACID : PHARMACEUTICAL Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips..moc.enilediugamrahp@ofni :liamE Need Help: Ask DIFFERENCE BETWEEN RECALL AND MOCK RECALL : PHARMACEUTICAL Difference between Recall and Mock Recall Recall and mock recall procedures for pharmaceuticals are different from each other. One is used to get back the marketed Pharmaceutical Guidelines : Total Pharmaceutical Solution --> PHARMACEUTICAL GUIDELINES* About
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GAP ANALYSIS FOR REGULATORY COMPLIANCE __May 30, 2021_ _GDP,
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Quality Assurance
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If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gapanalysis.
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PROCESS ANALYTICAL TECHNOLOGY (PAT) IN PHARMACEUTICALS __May 23, 2021_ _GDP,
GMP
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Regulatory
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Process Analytical Technology is a system for designing, analyzing and controlling manufacturing processes through timely measurement during processing. With the goal of ensuring final product quality, it analyzes raw and in-process materials. The PAT is now being deployed in the pharmaceutical industry, where it is seen as a technology that can help companies to improve their conformity with ma…____
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DETERGENTS USED FOR CLEANING OF PHARMACEUTICAL EQUIPMENTS __May 17, 2021_ _Cleaning,
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There are different types of detergents such as anionic detergents, cationic detergents, amphoteric detergents, alkaline detergent etc. This nature of the detergent depends upon the nature of the surfactant found in the detergent. These all have their specific use due to their cleaning properties.____
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QUALITY BY DESIGN (QBD) IN PHARMACEUTICALS__May 2, 2021_ _GMP
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Quality Control
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The term quality means the appropriateness for the intended use. In the field of pharmacy, quality refers to the state of being free from any contamination and ability to treat the disease intended for. The Quality of the pharmaceutical commodity can be assessed by in vivo or in vitro execution tests.____
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CELLULOSE MEMBRANE FILTERS USED IN PHARMACEUTICALS __Apr 26, 2021_ _Microbiology,
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Sterility
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Membrane filters are thin polymer films those have many microscopic pores. These filters have different pores sizes and used for different purposes accordingly. Membrane filters are used in various pharmaceutical activities. Cellulose filters are most commonly used filters in microbial analysis and reverse osmosis water systems. Most of the cellulose membrane filters are hydrophobic in nature.____
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DIFFERENT TYPES OF TEMPERATURE SENSORS __Apr 18, 2021_ _Engineering,
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Temperature sensors are used in different processes in pharmaceuticals. Different types of temperature sensors are used in different processes according to their accuracy needs.____
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BUFFER AREA AND ITS MAINTENANCE IN STERILE FACILITY __Apr 11, 2021_ _HVAC,
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The buffer area is the sterile zones in pharmaceutical manufacturing. Generally compounding area in sterile pharmaceutical preparation facility is known as the buffer area. The buffer area is always ISO 7 area (class 10,000) or better air quality.____
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DIFFERENT TYPES OF TITRATIONS __Apr 4, 2021_ _Quality Control,
Test
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Titrimetry, or in more general terms titration is a process which is carried out to analyze an unknown compound in order to determine the concentrations of various substances present in it. It is a well-known method used in laboratories for the sole purpose of quantitative and qualitative estimation of a particular chemical substance.____
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REQUIREMENTS AND MAINTENANCE OF HVAC SYSTEM IN MANUFACTURINGFACILITIES
__Mar 15, 2021_ _Engineering,
GMP
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HVAC
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Installation of a working and well-maintained heating, ventilation, and air conditioning system (HVAC) is a fundamental requirement in any pharmaceutical facility that value quality, and conducive working environment. Many pharmaceutical and biopharmaceutical products fail due to the improper environmental condition in the manufacturing area. Therefore, environmental conditions of the manufacturi…____
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STEPS TO MINIMIZE THE DATA INTEGRITY RISK__Mar 7, 2021_ _GDP
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GMP
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Data security and has become a hot issue in pharmaceuticals over the past few years because FDA and other regulatory agencies have issued many warning letters and import alerts due to lack of data integrity in records. Recently FDA has published a guideline in the form of question and answer for the compliance of data integrity in firms. These documents clarify the expectations of the FDA from ph…____
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WORKING OF A HVAC SYSTEM AND ITS FUNCTIONS __Feb 21, 2021_ _Engineering,
HVAC
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Heating, ventilation and air conditioning (HVAC) is the key to ensuring that the pharmaceutical products manufactured by an industry are of good quality. It ensures that there are all the necessary favorable conditions for successful manufacturing. A basic working HVAC system works as explained below: First, the system collects fresh air from outside the plant from where it is filtered using a fi…____
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MAINTENANCE OF PHARMACEUTICAL CLEAN AREA: FDA RECOMMENDATION __Feb 14, 2021_ _GMP,
HVAC
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Sterile
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Maintenance of pharmaceutical clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most important factor for the product quality and it can be achieved only by the proper maintenance of the manufacturing area.____
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DIFFERENCE BETWEEN HEPA AND ULPA FILTERS __Jan 31, 2021_ _Engineering,
GMP
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HVAC
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2 comments
The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air purification, and vacuum cleaner filters are High-Efficiency Particulate Air (HEPA) filters and Ultra-Low Particulate Air (ULPA) filters. Both these filters are designed to catch and remove tiny, airborne particulate matter such as bacteria, pollutants, and dust…____
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ISOLATORS AND THEIR USE IN STERILE MANUFACTURING __Jan 17, 2021_ _GMP,
Microbiology
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Sterile
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1 comment
An isolator can best be defined as an arrangement of physical barricades which are incorporated to a degree that the isolator is capable of being sealed; so as that it can undertake a scheduled leak tests that are based on pressure, to attain stated limits.____
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RESTRICTED ACCESS BARRIER SYSTEM (RABS) IN PHARMACEUTICALS __Jan 10, 2021_ _Equipment,
Production
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Sterile
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The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms and useful in aseptic filling systems. RABS process in an ISO 5 environment, similar to isolators. RABS manually performs bio-decontamination. If the doors are ever opened, the system must be sanitized correctly, a line clearance must be performed, and theint…
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