Are you over 18 and want to see adult content?
More Annotations
A complete backup of thecasestudysolutions.com
Are you over 18 and want to see adult content?
A complete backup of gelatofestival.com
Are you over 18 and want to see adult content?
A complete backup of vegrecipesofindia.com
Are you over 18 and want to see adult content?
A complete backup of danwilliamsroofing.com
Are you over 18 and want to see adult content?
Favourite Annotations
A complete backup of whiskiedwanderlust.com
Are you over 18 and want to see adult content?
A complete backup of karvycomputershare.com
Are you over 18 and want to see adult content?
A complete backup of download24x7.com
Are you over 18 and want to see adult content?
A complete backup of youmakefashion.fr
Are you over 18 and want to see adult content?
Text
indirectly
SOP FOR COMPUTER SYSTEM VALIDATION IN PHARMACEUTICAL INDUSTRY Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This SOP is applicable for presently installed / available / planned computerized systems. This practices and approaches can be also used for new such systems which may bebrought by the
SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : D VALUE, Z VALUE AND F VALUE The z-value is obtained by plotting the logarithms of at least 2 D-values against temperature or by the formula: Z = (T 2 -T 1 )/ (logD 1 -logD 2) Where T = temperature and D = D-value. The z-value of an organism is the temperature, in degrees Fahrenheit, that is required for the thermal destruction curve to move one log cycle. SOP OF CONTROL SAMPLE MANAGEMENT 1.Objective : To lay down procedure for handling of Control Sample. Also known as Retention Sample or Reserved Sample. 2. Scope : This procedure is applicable for sampling, storage, issuance and destruction of Control Sample of Key Raw material, Intermediate, Packing material, drug substance and drug product. 3. Responsibility: QC & QA 4. Definitions: DO'S & DONT'S IN MICROBIOLOGY LAB Objective : To lay down the procedure of Do’s and Don’ts to be followed in Microbiology Laboratory. Scope: Applicable to Microbiology Lab. Responsibility: All persons working in Microbiology Lab. Procedure: Do’s in Microbiology Lab Always maintain cleanliness & hygienic conditions in Lab. Personal hygiene and good habits should be practiced while working in Microbiology Laboratory. STABILITY STUDY PROTOCOL TEMPLATE Significant change criteria. 10. Test procedure and criteria. 11. Report generation. Objective of study. This protocol is prepared to carry out stability study of process validation and ongoing batches of Aspirin 75 mg Tablets, batch size 100000 Tablets as per ICH guideline. Each Aspirin Tablet contains 75 mg of Aspirin BP. TOOLING FOR TABLETING TOOLING FOR TABLETING. A set of tooling consists of upper punch, lower punch, and die. The upper punch has a shorter stem. The lower punch stem is longer because it travels longer distances up and down in the die for filling, compression, and ejection, thereby sealing the die hole from below during the entire process of compression. SOP: HANDLING OF RETURNED GOODS 1.Objective : To lay down the procedure for handling of returned goods from distributor / customer end. 2. Scope: This procedure is applicable for identifying, holding and/or disposition of Drugs Product & Drug Substances returned from distributors and / or customers. 3. Responsibilities QA, QC, Marketing, Warehouse, Production 4. Definitions: Returned Goods: The material which GLOBAL MEDICAL DEVICE MARKET OUTLOOK, 2018 Global Healthcare Revenue by Sector in 2017 and 2018 2017 2018 Growth Rate Total Healthcare Industry ($ Billion) 1,768.61 1,853.83 4.82%1,195 371
SOP OF CONTROL SAMPLE MANAGEMENT 1.Objective : To lay down procedure for handling of Control Sample. Also known as Retention Sample or Reserved Sample. 2. Scope : This procedure is applicable for sampling, storage, issuance and destruction of Control Sample of Key Raw material, Intermediate, Packing material, drug substance and drug product. 3. Responsibility: QC & QA 4. Definitions: SOP OF GDP | GOOD DOCUMENTATION PRACTICES IN PHARMA INDUSTRY 1.Objective : To lay down a procedure for good documentation practices. 2. Scope: This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug Products, Drug Substances. 3. Responsibilities: It is the responsibility of all concerned who are involved directly orindirectly
DO'S & DONT'S IN MICROBIOLOGY LAB Objective : To lay down the procedure of Do’s and Don’ts to be followed in Microbiology Laboratory. Scope: Applicable to Microbiology Lab. Responsibility: All persons working in Microbiology Lab. Procedure: Do’s in Microbiology Lab Always maintain cleanliness & hygienic conditions in Lab. Personal hygiene and good habits should be practiced while working in Microbiology Laboratory. DEVIATION - PHARMASTATE BLOG DEVIATION:- Deviation is an unexpected event that occurs during the on-going operation / Activity / Documentation / Entries at any stage of Receipt, Storage and Manufacturing, Analysis and Distribution of Drug Products / Intermediates / Raw Materials / Packing materials.Deviations are to be reported as and when they occur and to be investigated for impact assessment. SOP FOR COMPUTER SYSTEM VALIDATION IN PHARMACEUTICAL INDUSTRY Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This SOP is applicable for presently installed / available / planned computerized systems. This practices and approaches can be also used for new such systems which may bebrought by the
HVAC DESIGN FOR PHARMACEUTICAL FACILITIES In pharmaceutical manufacturing, how space conditions impact the product being made is of primary importance. The pharmaceutical facilities are closely supervised by the U.S. food and drug administration (FDA), which requires manufacturing companies to conform to cGMP (current Good Manufacturing Practices). These regulations, which have the force of law, require that manufacturers, TOOLING FOR TABLETING TOOLING FOR TABLETING. A set of tooling consists of upper punch, lower punch, and die. The upper punch has a shorter stem. The lower punch stem is longer because it travels longer distances up and down in the die for filling, compression, and ejection, thereby sealing the die hole from below during the entire process of compression. SOP: HANDLING OF RETURNED GOODS 1.Objective : To lay down the procedure for handling of returned goods from distributor / customer end. 2. Scope: This procedure is applicable for identifying, holding and/or disposition of Drugs Product & Drug Substances returned from distributors and / or customers. 3. Responsibilities QA, QC, Marketing, Warehouse, Production 4. Definitions: Returned Goods: The material which STABILITY STUDY PROTOCOL TEMPLATE Significant change criteria. 10. Test procedure and criteria. 11. Report generation. Objective of study. This protocol is prepared to carry out stability study of process validation and ongoing batches of Aspirin 75 mg Tablets, batch size 100000 Tablets as per ICH guideline. Each Aspirin Tablet contains 75 mg of Aspirin BP. D VALUE, Z VALUE AND F VALUE The z-value is obtained by plotting the logarithms of at least 2 D-values against temperature or by the formula: Z = (T 2 -T 1 )/ (logD 1 -logD 2) Where T = temperature and D = D-value. The z-value of an organism is the temperature, in degrees Fahrenheit, that is required for the thermal destruction curve to move one log cycle. ENGINEERING SOP -FAT : FACTORY ACCEPTANCE TEST & SAT Learn about Factory Acceptance Test and Site Acceptance Test in qualification of equipments and systems to the accepted standards for Pharma manufacturing. INDIAN PHARMA WORKFORCE Explore in-depth about Indian Pharma Industry while it is projected to provide Employment opportunity to about 35 lakh professionals by theyear 2022.
SOP FOR PRODUCT RECALL IN PHARMACEUTICAL INDUSTRY Know about procedures involved in product recall in Pharma industry to rectify mistakes meted out in manufacturing, storage, distribution and other product touch points. DEVIATION - PHARMASTATE BLOG DEVIATION:- Deviation is an unexpected event that occurs during the on-going operation / Activity / Documentation / Entries at any stage of Receipt, Storage and Manufacturing, Analysis and Distribution of Drug Products / Intermediates / Raw Materials / Packing materials.Deviations are to be reported as and when they occur and to be investigated for impact assessment.SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : SOP - PLANNED MODIFICATION Learn about SOP for planned modification involving alteration, up-gradation or replacement of equipment or manufacturing facility due to breakdown maintenance. CONCURRENT VALIDATION Concurrent Validation Process. The concurrent validation process is identical to that of prospective validation. The process starts with the development of a Validation Plan, followed by the DQ, Risk Assessment (RA), IQ, OQ and PQ phases after which process, computer, analytical and cleaning validations are performed, ending with a finalreport.
QUALITY RISK MANAGEMENT Quality Risk Management (QRM) gives the possibility of determining the impact of a deviation in a process or product in an objective manner, in order to categorise it and facilitate its treatment. ICH Q9 describes in detail a methodology to perform QRM, and defines it as “a systematic process for the assessment, control, communication and EVALUATION OF TABLETS The strength of a tablet was determined by following ways; (a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there is a sharp snap, the tablet is an acceptable strength. (b) Tablet hardness can be defined as the force required breaking a tablet in a diametric compression. TABLET COATING AND ITS DIFFERENT METHODS INTRODUCTION:-Tablet is a pharmaceutical solid dosage form, comprising a mixture of active substances and excipients, commonly in powder form, pressed or compacted right into a stable.Capsules Dosage form is one of a most desired dosage form everywhere in the world. Almost all drug molecules may be formulated in a tablet and procedure of producing of drugs is very simple, and SOP OF GDP | GOOD DOCUMENTATION PRACTICES IN PHARMA INDUSTRY 1.Objective : To lay down a procedure for good documentation practices. 2. Scope: This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug Products, Drug Substances. 3. Responsibilities: It is the responsibility of all concerned who are involved directly orindirectly
SOP FOR COMPUTER SYSTEM VALIDATION IN PHARMACEUTICAL INDUSTRY Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This SOP is applicable for presently installed / available / planned computerized systems. This practices and approaches can be also used for new such systems which may bebrought by the
SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : D VALUE, Z VALUE AND F VALUE The z-value is obtained by plotting the logarithms of at least 2 D-values against temperature or by the formula: Z = (T 2 -T 1 )/ (logD 1 -logD 2) Where T = temperature and D = D-value. The z-value of an organism is the temperature, in degrees Fahrenheit, that is required for the thermal destruction curve to move one log cycle. SOP OF GDP | GOOD DOCUMENTATION PRACTICES IN PHARMA INDUSTRY 1.Objective : To lay down a procedure for good documentation practices. 2. Scope: This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug Products, Drug Substances. 3. Responsibilities: It is the responsibility of all concerned who are involved directly orindirectly
SOP FOR COMPUTER SYSTEM VALIDATION IN PHARMACEUTICAL INDUSTRY Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This SOP is applicable for presently installed / available / planned computerized systems. This practices and approaches can be also used for new such systems which may bebrought by the
SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : D VALUE, Z VALUE AND F VALUE The z-value is obtained by plotting the logarithms of at least 2 D-values against temperature or by the formula: Z = (T 2 -T 1 )/ (logD 1 -logD 2) Where T = temperature and D = D-value. The z-value of an organism is the temperature, in degrees Fahrenheit, that is required for the thermal destruction curve to move one log cycle. SOP OF CONTROL SAMPLE MANAGEMENT 1.Objective : To lay down procedure for handling of Control Sample. Also known as Retention Sample or Reserved Sample. 2. Scope : This procedure is applicable for sampling, storage, issuance and destruction of Control Sample of Key Raw material, Intermediate, Packing material, drug substance and drug product. 3. Responsibility: QC & QA 4. Definitions: DO'S & DONT'S IN MICROBIOLOGY LAB Objective : To lay down the procedure of Do’s and Don’ts to be followed in Microbiology Laboratory. Scope: Applicable to Microbiology Lab. Responsibility: All persons working in Microbiology Lab. Procedure: Do’s in Microbiology Lab Always maintain cleanliness & hygienic conditions in Lab. Personal hygiene and good habits should be practiced while working in Microbiology Laboratory. STABILITY STUDY PROTOCOL TEMPLATE Significant change criteria. 10. Test procedure and criteria. 11. Report generation. Objective of study. This protocol is prepared to carry out stability study of process validation and ongoing batches of Aspirin 75 mg Tablets, batch size 100000 Tablets as per ICH guideline. Each Aspirin Tablet contains 75 mg of Aspirin BP. TOOLING FOR TABLETING TOOLING FOR TABLETING. A set of tooling consists of upper punch, lower punch, and die. The upper punch has a shorter stem. The lower punch stem is longer because it travels longer distances up and down in the die for filling, compression, and ejection, thereby sealing the die hole from below during the entire process of compression. SOP: HANDLING OF RETURNED GOODS 1.Objective : To lay down the procedure for handling of returned goods from distributor / customer end. 2. Scope: This procedure is applicable for identifying, holding and/or disposition of Drugs Product & Drug Substances returned from distributors and / or customers. 3. Responsibilities QA, QC, Marketing, Warehouse, Production 4. Definitions: Returned Goods: The material which GLOBAL MEDICAL DEVICE MARKET OUTLOOK, 2018 Global Healthcare Revenue by Sector in 2017 and 2018 2017 2018 Growth Rate Total Healthcare Industry ($ Billion) 1,768.61 1,853.83 4.82%1,195 371
IMPORTANCE OF PHARMACEUTICAL MARKETING Know more about Pharma Marketing in establishing brand reputation in the market, enabling penetration into new geographies while retaining the existing customer base. ENGINEERING SOP -FAT : FACTORY ACCEPTANCE TEST & SAT Learn about Factory Acceptance Test and Site Acceptance Test in qualification of equipments and systems to the accepted standards for Pharma manufacturing. SOP - PLANNED MODIFICATION Learn about SOP for planned modification involving alteration, up-gradation or replacement of equipment or manufacturing facility due to breakdown maintenance. DEVIATION - PHARMASTATE BLOG DEVIATION:- Deviation is an unexpected event that occurs during the on-going operation / Activity / Documentation / Entries at any stage of Receipt, Storage and Manufacturing, Analysis and Distribution of Drug Products / Intermediates / Raw Materials / Packing materials.Deviations are to be reported as and when they occur and to be investigated for impact assessment.SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : CONCURRENT VALIDATION Concurrent Validation Process. The concurrent validation process is identical to that of prospective validation. The process starts with the development of a Validation Plan, followed by the DQ, Risk Assessment (RA), IQ, OQ and PQ phases after which process, computer, analytical and cleaning validations are performed, ending with a finalreport.
QUALITY RISK MANAGEMENT Quality Risk Management (QRM) gives the possibility of determining the impact of a deviation in a process or product in an objective manner, in order to categorise it and facilitate its treatment. ICH Q9 describes in detail a methodology to perform QRM, and defines it as “a systematic process for the assessment, control, communication and HVAC DESIGN FOR PHARMACEUTICAL FACILITIES In pharmaceutical manufacturing, how space conditions impact the product being made is of primary importance. The pharmaceutical facilities are closely supervised by the U.S. food and drug administration (FDA), which requires manufacturing companies to conform to cGMP (current Good Manufacturing Practices). These regulations, which have the force of law, require that manufacturers, TABLET COATING AND ITS DIFFERENT METHODS INTRODUCTION:-Tablet is a pharmaceutical solid dosage form, comprising a mixture of active substances and excipients, commonly in powder form, pressed or compacted right into a stable.Capsules Dosage form is one of a most desired dosage form everywhere in the world. Almost all drug molecules may be formulated in a tablet and procedure of producing of drugs is very simple, and EVALUATION OF TABLETS The strength of a tablet was determined by following ways; (a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there is a sharp snap, the tablet is an acceptable strength. (b) Tablet hardness can be defined as the force required breaking a tablet in a diametric compression. DO'S & DONT'S IN MICROBIOLOGY LAB Objective : To lay down the procedure of Do’s and Don’ts to be followed in Microbiology Laboratory. Scope: Applicable to Microbiology Lab. Responsibility: All persons working in Microbiology Lab. Procedure: Do’s in Microbiology Lab Always maintain cleanliness & hygienic conditions in Lab. Personal hygiene and good habits should be practiced while working in Microbiology Laboratory.SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : D VALUE, Z VALUE AND F VALUE The z-value is obtained by plotting the logarithms of at least 2 D-values against temperature or by the formula: Z = (T 2 -T 1 )/ (logD 1 -logD 2) Where T = temperature and D = D-value. The z-value of an organism is the temperature, in degrees Fahrenheit, that is required for the thermal destruction curve to move one log cycle. SOP OF GDP | GOOD DOCUMENTATION PRACTICES IN PHARMA INDUSTRY 1.Objective : To lay down a procedure for good documentation practices. 2. Scope: This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug Products, Drug Substances. 3. Responsibilities: It is the responsibility of all concerned who are involved directly orindirectly
CONCURRENT VALIDATION Concurrent Validation Process. The concurrent validation process is identical to that of prospective validation. The process starts with the development of a Validation Plan, followed by the DQ, Risk Assessment (RA), IQ, OQ and PQ phases after which process, computer, analytical and cleaning validations are performed, ending with a finalreport.
EVALUATION OF TABLETS The strength of a tablet was determined by following ways; (a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there is a sharp snap, the tablet is an acceptable strength. (b) Tablet hardness can be defined as the force required breaking a tablet in a diametric compression. STABILITY STUDY PROTOCOL TEMPLATE Significant change criteria. 10. Test procedure and criteria. 11. Report generation. Objective of study. This protocol is prepared to carry out stability study of process validation and ongoing batches of Aspirin 75 mg Tablets, batch size 100000 Tablets as per ICH guideline. Each Aspirin Tablet contains 75 mg of Aspirin BP.SOP ON CAPA
Objective : To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). 2.Scope: This SOP is applicable for all Corrective Actions and Preventive Actions (CAPA) initiated for following GxP systems, processes and records, but not limited to SOP FOR COMPUTER SYSTEM VALIDATION IN PHARMACEUTICAL INDUSTRY Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This SOP is applicable for presently installed / available / planned computerized systems. This practices and approaches can be also used for new such systems which may bebrought by the
SOP FOR RAW MATERIAL FIFO AND FEFO PROCEDURE 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To lay down a procedure for Raw Material FIFO and FEFO Procedure. 2.0 SCOPE: 2.1 This SOP is applicable for Raw Material FIFO and FEFO Procedure. 3.0 RESPONSIBILITY: 3.1 The Officer /Supervisor Store shall be: 3.1.1 Responsible for Raw Material FIFO and FEFO Procedure. 4.0 DO'S & DONT'S IN MICROBIOLOGY LAB Objective : To lay down the procedure of Do’s and Don’ts to be followed in Microbiology Laboratory. Scope: Applicable to Microbiology Lab. Responsibility: All persons working in Microbiology Lab. Procedure: Do’s in Microbiology Lab Always maintain cleanliness & hygienic conditions in Lab. Personal hygiene and good habits should be practiced while working in Microbiology Laboratory.SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : D VALUE, Z VALUE AND F VALUE The z-value is obtained by plotting the logarithms of at least 2 D-values against temperature or by the formula: Z = (T 2 -T 1 )/ (logD 1 -logD 2) Where T = temperature and D = D-value. The z-value of an organism is the temperature, in degrees Fahrenheit, that is required for the thermal destruction curve to move one log cycle. SOP OF GDP | GOOD DOCUMENTATION PRACTICES IN PHARMA INDUSTRY 1.Objective : To lay down a procedure for good documentation practices. 2. Scope: This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug Products, Drug Substances. 3. Responsibilities: It is the responsibility of all concerned who are involved directly orindirectly
CONCURRENT VALIDATION Concurrent Validation Process. The concurrent validation process is identical to that of prospective validation. The process starts with the development of a Validation Plan, followed by the DQ, Risk Assessment (RA), IQ, OQ and PQ phases after which process, computer, analytical and cleaning validations are performed, ending with a finalreport.
EVALUATION OF TABLETS The strength of a tablet was determined by following ways; (a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there is a sharp snap, the tablet is an acceptable strength. (b) Tablet hardness can be defined as the force required breaking a tablet in a diametric compression. STABILITY STUDY PROTOCOL TEMPLATE Significant change criteria. 10. Test procedure and criteria. 11. Report generation. Objective of study. This protocol is prepared to carry out stability study of process validation and ongoing batches of Aspirin 75 mg Tablets, batch size 100000 Tablets as per ICH guideline. Each Aspirin Tablet contains 75 mg of Aspirin BP.SOP ON CAPA
Objective : To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). 2.Scope: This SOP is applicable for all Corrective Actions and Preventive Actions (CAPA) initiated for following GxP systems, processes and records, but not limited to SOP FOR COMPUTER SYSTEM VALIDATION IN PHARMACEUTICAL INDUSTRY Objective: To lay down a procedure for computer system validation. Scope: This procedure is applicable for all computerized system used in GxP regulated activities. This SOP is applicable for presently installed / available / planned computerized systems. This practices and approaches can be also used for new such systems which may bebrought by the
SOP FOR RAW MATERIAL FIFO AND FEFO PROCEDURE 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To lay down a procedure for Raw Material FIFO and FEFO Procedure. 2.0 SCOPE: 2.1 This SOP is applicable for Raw Material FIFO and FEFO Procedure. 3.0 RESPONSIBILITY: 3.1 The Officer /Supervisor Store shall be: 3.1.1 Responsible for Raw Material FIFO and FEFO Procedure. 4.0 IMPORTANCE OF PHARMACEUTICAL MARKETING Know more about Pharma Marketing in establishing brand reputation in the market, enabling penetration into new geographies while retaining the existing customer base. ENGINEERING SOP -FAT : FACTORY ACCEPTANCE TEST & SAT Learn about Factory Acceptance Test and Site Acceptance Test in qualification of equipments and systems to the accepted standards for Pharma manufacturing. SOP - PLANNED MODIFICATION Learn about SOP for planned modification involving alteration, up-gradation or replacement of equipment or manufacturing facility due to breakdown maintenance.SOP FOR SAMPLING
Sample: Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples. 4. Responsibility : CLEAN ROOMS IN PHARMACEUTICAL MANUFACTURING A Clean- Room is an environment in which several parameters (like Contamination, Pressurization, Temperature & Humidity and Personnel Access) are controlled, monitored and maintained. Basically Clean- Room is an area in which the Quantity & Size of Air- borne particles are controlled in order to limit contamination. – It is constructed& operated in a
EVALUATION OF TABLETS The strength of a tablet was determined by following ways; (a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there is a sharp snap, the tablet is an acceptable strength. (b) Tablet hardness can be defined as the force required breaking a tablet in a diametric compression.FRIABILITY TEST
(A) Subjective: Procedure for performing Friability test on Tablets. (B) Purpose: This procedure is applicable for friability test on tablets and calibration of friabilator used in pharmaceutical company. (C) Name of the Apparatus: Friabilator. (D) Significance of Friability Test: This test is intended to determine the Physical Strength of the Tablet. (E) Description of Apparatus: QUALITY RISK MANAGEMENT Quality Risk Management (QRM) gives the possibility of determining the impact of a deviation in a process or product in an objective manner, in order to categorise it and facilitate its treatment. ICH Q9 describes in detail a methodology to perform QRM, and defines it as “a systematic process for the assessment, control, communication and SANITIZATION TECHNIQUES FOR WATER SYSTEM IN PHARMA SANITIZATION:- Microbial control in water systems is achieved primarily through sanitization practices.Systems can be sanitized using either thermal or (photo-) chemical means. THERMAL SANITIZATION:- Thermal approaches to system sanitization include periodic or continuously circulating hot water and the use of steam.Temperatures of 65°–80° are most commonly used for ALCOA IN PHARMA INDUSTRY ALCOA IN PHARMA INDUSTRY. The acronym ALCOA is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original, and Accurate.Skip to content
* Home
* About
* Contact us
* YouTube
* Website
* Search
Search for: Search
PHARMASTATE BLOG
PHARMACEUTICAL GUIDELINES – JOBS – NEWS – DATA: FOR PHARMAPROFESSIONALS
* Pharma Jobs
* Reference Jobs
* Walk-in Interviews* Fresher Jobs
* Sales & Marketing
* QA & QC
* Production Jobs
* Regulatory
* R&D
* Pharmacist
* Printing & Packing * Purchase & Accounts* Medical Writer
* Interviews Q&A
* Pharma Industry News* Daily Pharma News
* Breaking News
* Pharma Share Market* Guidelines & SOPs
* Quality Assurance
* Quality Control
* Production
* Microbiology
* Validation
* GMP & Guidelines
* Audits
* SOPs
* Exclusive
* Pharma Trivia & Stats.* Quiz
* The Speaking Mind
* PharmaState Desk
* New Drug Approvals* Case Study
* Survey
* Services
* Career Counseling
* Resume & Cover Letter Service * Generate Pharma Business Leads with B2B feature* Advertise with us
Daily Pharma News
,
Pharma Industry News PHARMA INDUSTRY NEWS @20 JANUARY 202020/01/2020
— 0
Comments
Fresher Jobs , Printing &Packing ,
Production Jobs
, QA & QC
, R&D
, Walk-in Interviews PHARMA COMPANY WALK-IN INTERVIEWS FOR VARIOUS DEPARTMENTS 20TH & 25THJAN 2020
20/01/2020
— 0 Comments
Fresher Jobs , Printing &Packing ,
Production Jobs
, QA & QC
, R&D
, Sales & Marketing
, Walk-in
Interviews
PHARMA COMPANY WALK-IN INTERVIEWS FOR VARIOUS DEPARTMENTS ON 19TH &24TH JAN 2020
18/01/2020
— 0 Comments
Fresher Jobs , Printing &Packing ,
Production Jobs
,
Purchase & Accounts
, QA & QC
, R&D
, Sales & Marketing
, Walk-in
Interviews
PHARMA COMPANY WALK-IN INTERVIEWS FOR VARIOUS DEPARTMENTS 18TH TO 20THJAN 2020
17/01/2020
— 0 Comments
Fresher Jobs , Printing &Packing ,
Production Jobs
, QA & QC
, R&D
, Sales & Marketing
, Walk-in
Interviews
PHARMA COMPANY WALK-IN INTERVIEWS FOR VARIOUS DEPARTMENTS 16TH TO 19THJAN 2020
16/01/2020
— 0 Comments
Daily Pharma News
,
Pharma Industry News PHARMA INDUSTRY NEWS @15 JANUARY 202015/01/2020
— 0
Comments
Fresher Jobs , ProductionJobs , QA
& QC , R&D
, Walk-in Interviews PHARMA COMPANY WALK-IN INTERVIEWS FOR VARIOUS DEPARTMENTS 15TH TO 19THJAN 2020
15/01/2020
— 0 Comments
Fresher Jobs , Printing &Packing ,
Production Jobs
, QA & QC
, R&D
, Sales & Marketing
, Walk-in
Interviews
PHARMA COMPANY WALK-IN INTERVIEWS FOR VARIOUS DEPARTMENTS 14TH TO 19THJAN 2020
13/01/2020
— 0 Comments
Daily Pharma News
,
Pharma Industry News PHARMA INDUSTRY NEWS @11 JANUARY 202011/01/2020
— 0
Comments
Fresher Jobs , Printing &Packing ,
Production Jobs
, QA & QC
, R&D
, Walk-in Interviews PHARMA COMPANY WALK-IN INTERVIEWS FOR VARIOUS DEPARTMENTS 12TH TO 14THJAN 2020
11/01/2020
— 0 Comments
POSTS NAVIGATION
Older posts
PHARMA JOBS
B2B LEADS FOR PHARMA BUSINESSES KNOW MORE ABOUT PHARMASTATEVideo Player
https://www.youtube.com/watch?v=onLhjDx7UR000:00
00:00
00:28
Use Up/Down Arrow keys to increase or decrease volume.CATEGORIES
* Case Study (7)
* Exclusive (72)
* PharmaState Desk
(49)
* The Speaking Mind
(33)
* Fresher Jobs (65) * Interviews for Pharmaceuticals(6)
* New Drug Approvals(19)
* Pharma Industry Guidelines(345)
* Articles
(13)
* Audits
(7)
* Equipments
(4)
* Flow Charts
(15)
* GMP & Guidelines
(48)
* Microbiology
(37)
* Production
(74)
* Quality Assurance
(132)
* Quality Control
(67)
* SOPs
(96)
* Useful Formats
(9)
* Validation
(33)
* Pharma Industry News(63)
* Breaking News
(1)
* Daily Pharma News
(56)
* Pharma Share Market(3)
* Pharma Industry Quiz(26)
* Pharma Trivia & Stats.(22)
* PharmaState Jobs Portal Updates(1)
* Printing & Packing(37)
* Production Jobs
(80)
* Purchase & Accounts(13)
* QA & QC (73)
* R&D (41)
* Regulatory (20)
* Sales & Marketing
(16)
* Survey (3)
* Walk-in Interviews(130)
RECENT POSTS
* Pharma Industry News @20 January 202020/01/2020
* Pharma Company Walk-in Interviews for Various Departments 20th &25th Jan 2020
20/01/2020
* Pharma Company Walk-in Interviews for Various Departments on 19th& 24th Jan 2020
18/01/2020
* Pharma Company Walk-in Interviews for Various Departments 18th to20th Jan 2020
17/01/2020
* Pharma Company Walk-in Interviews for Various Departments 16th to19th Jan 2020
16/01/2020
COPYRIGHT NOTICE
PharmaState Blog and pharmastate.com | Pharmaceutical Industry Guidelines, SOPs, News, Views & Articles by Industry Experts. Articles/SOPs/Compilations/Published Content on pharmastate.blog is protected by Indian & International Copyright Laws. Reproduction and Distribution of the same without written permission is prohibited. Mail us at: info@pharmastate.com. Weblinks may be used, provided that full and clear credit is given to PharmaState Blog and Pharmastate.com with appropriate and specific direction to the original content.DISCLAIMER
All compilations/publications are for informational purposes only & we do not suggest to take any action/decision on the basis of this information. We do not guarantee the accuracy of this information or any results and the user is advised to take any decision or action on his/her sole discretion & responsibility. For the latest updates pertaining to this compilation visit the relevant website.PHARMASTATE
Exclusive platform for Professionals working in the pharmaceuticals industry for Jobs, News, Pharmaceutical Guidelines & SOPs, B2B Networking, Professional Profile display space. Find more at https://pharmastate.com 2020 PharmaState BlogPharmaState Blog
Proudly powered by WordPress Theme: Rowling.Details
Copyright © 2024 ArchiveBay.com. All rights reserved. Terms of Use | Privacy Policy | DMCA | 2021 | Feedback | Advertising | RSS 2.0