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IVT NETWORK
IVT Network expands the global knowledge base for validation and compliance professionals in FDA regulated industries with educational publications, conferences, and more. APPLICATION OF GMP IN THE CANNABIS INDUSTRY ABSTRACT. Many European Union (EU) countries have legalized or decriminalized the medical use of cannabis to some degree. The advent of broad acceptance of medical cannabis as public opinion shifts in the EU is driving the need for the cannabis industry to implement strict regulatory controls on the production of cannabis products. A BASIC UNDERSTANDING OF DESIGN CONTROLS It is important for engineers to note that design controls are an integral part of making any device; if done correctly, design controls can save companies and designers last minute redesign and possible recall. Design control consists of eight parts: general requirements, planning for design and development, design input, design output,design
6 STEPS TO COMPLIANT EQUIPMENT QUALIFICATION Taken from a presentation at IVT’s Validation Week, the following are the six steps to a compliant equipment qualification. 1. Assemble the Validation Team. A multi-functional team, led by a project leader, should be established to plan and oversee the validation activities. A team approach to will guarantee the validation processes are well MANUFACTURING DATE OF DRUG SUBSTANCES Hence, the retest date is assigned based on the manufacturing date and the retest period. Surprisingly, there is no regulation provided regarding the assignment of the manufacturing date of drug substance. Some stakeholders intentionally claim that the formation of the chemical core structure of a drug substance defines the manufacturingdate.
CHANGE CONTROL FOR FUNCTIONALLY EQUIVALENT LIKE-FOR-LIKE At the other extreme, changes may be completely insignificant with minimal risk to patient, product, process, or equipment. Functionally equivalent (i.e., “like-for-like”) changes are often judged to be changes in this latter category. Like-for-like changes are minimal changes made to processes, equipment, utilities, facilities, computers DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status. ESTABLISHING A VALIDATION PROCESS FOR CLOUD HOSTED ABSTRACT . This article introduces the process of selecting a suitable cloud provider. It also discusses the different procedures, or other supporting documentation, that must be in place to define responsibilities and commitments between the service provider and theclient.
FDA STORYTELLING—FDA INSPECTIONAL OBSERVATIONS & WARNING The following FDA Form 483 Inspectional Observations and FDA Warning Letter citations are examples of significant violations of current good manufacturing practice (cGMP) regulations for Finished Pharmaceuticals, Code of Federal Regulations Title 21 Parts 210 and 211, identified by FDA investigators at various companies. The purpose of this supplement is to review the compiled RESOLVING THE 3 TYPES OF VALIDATION EXCEPTIONSIVT NETWORK
IVT Network expands the global knowledge base for validation and compliance professionals in FDA regulated industries with educational publications, conferences, and more. APPLICATION OF GMP IN THE CANNABIS INDUSTRY ABSTRACT. Many European Union (EU) countries have legalized or decriminalized the medical use of cannabis to some degree. The advent of broad acceptance of medical cannabis as public opinion shifts in the EU is driving the need for the cannabis industry to implement strict regulatory controls on the production of cannabis products. A BASIC UNDERSTANDING OF DESIGN CONTROLS It is important for engineers to note that design controls are an integral part of making any device; if done correctly, design controls can save companies and designers last minute redesign and possible recall. Design control consists of eight parts: general requirements, planning for design and development, design input, design output,design
6 STEPS TO COMPLIANT EQUIPMENT QUALIFICATION Taken from a presentation at IVT’s Validation Week, the following are the six steps to a compliant equipment qualification. 1. Assemble the Validation Team. A multi-functional team, led by a project leader, should be established to plan and oversee the validation activities. A team approach to will guarantee the validation processes are well MANUFACTURING DATE OF DRUG SUBSTANCES Hence, the retest date is assigned based on the manufacturing date and the retest period. Surprisingly, there is no regulation provided regarding the assignment of the manufacturing date of drug substance. Some stakeholders intentionally claim that the formation of the chemical core structure of a drug substance defines the manufacturingdate.
CHANGE CONTROL FOR FUNCTIONALLY EQUIVALENT LIKE-FOR-LIKE At the other extreme, changes may be completely insignificant with minimal risk to patient, product, process, or equipment. Functionally equivalent (i.e., “like-for-like”) changes are often judged to be changes in this latter category. Like-for-like changes are minimal changes made to processes, equipment, utilities, facilities, computers DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status. ESTABLISHING A VALIDATION PROCESS FOR CLOUD HOSTED ABSTRACT . This article introduces the process of selecting a suitable cloud provider. It also discusses the different procedures, or other supporting documentation, that must be in place to define responsibilities and commitments between the service provider and theclient.
FDA STORYTELLING—FDA INSPECTIONAL OBSERVATIONS & WARNING The following FDA Form 483 Inspectional Observations and FDA Warning Letter citations are examples of significant violations of current good manufacturing practice (cGMP) regulations for Finished Pharmaceuticals, Code of Federal Regulations Title 21 Parts 210 and 211, identified by FDA investigators at various companies. The purpose of this supplement is to review the compiled RESOLVING THE 3 TYPES OF VALIDATION EXCEPTIONS A BASIC UNDERSTANDING OF DESIGN CONTROLS It is important for engineers to note that design controls are an integral part of making any device; if done correctly, design controls can save companies and designers last minute redesign and possible recall. Design control consists of eight parts: general requirements, planning for design and development, design input, design output,design
TEMPERATURE SCANNERS: LIMITED VALUE IN DETECTING EMPLOYEE A related limitation is the lack of a single agreed-upon upper limit for normal temperature among the medical community, with different opinions for bioregulation outside of the norm expressing values between 37.2 and 38.3°C for the onset of fever. Fevers do not typically go higher than 41 to 42°C. 6 STEPS TO COMPLIANT EQUIPMENT QUALIFICATION Taken from a presentation at IVT’s Validation Week, the following are the six steps to a compliant equipment qualification. 1. Assemble the Validation Team. A multi-functional team, led by a project leader, should be established to plan and oversee the validation activities. A team approach to will guarantee the validation processes are well PHASES OF A FUNCTIONAL RISK ASSESSMENT Phase 1. The severity of a fault is any impact on patient safety, product quality, or data integrity. Probability is the likelihood of the fault occurring at all. The relationship between the severity and probability is the risk class. There are numerous faults that can, and do, occur in a GMP environment that can be considered to have a low ANTIMICROBIAL EFFECTIVENESS TESTING VALIDATION STRATEGIES TABLE 2: ANTIMICROBIAL EFFECTIVENESS TESTING COMPARISON . REQUIREMENT. USP JP 19. EP 5.1.3. COMPROMISE. REASON FOR TEST. Antimicrobial Effectiveness, whether inherent in the product or produced because of a preservative, must be demonstrated for all injections packaged in multiple-dose containers or for other products containing antimicrobial preservatives. AUDIT TRAILS REVIEWS FOR DATA INTEGRITY Low risk system can be reviewed on a yearly or bi-annual basis. The scope of the audit trail reviews for medium and low risk systems should include the following: Data changes. Data deletions. Unauthorized access or transactions. To implement audit trail A QUALITY RISK MANAGEMENT APPROACH FOR QUALIFICATION AND For commissioning and qualification of facilities, utilities, and equipment (F/U/E), a quality risk management approach can be used to identify and evaluate risk. The strategy will identify areas that will require more evaluation, adjustments, or re-design prior to implementation. Furthermore, it will provide controls to reduce riskto an
STREAMLINING CHANGE CONTROL: IMPLEMENTING A RISK BASED One factor that influences some of the challenges including the inefficiencies and ineffectiveness of the process is the fact that the traditional process takes a one size fits all approach to change management. Inadequate definition of change classifications has a direct negative impact on the change control process and disables theability to
ROADMAP TO GMP COMPLIANCE VOL. III Roadmap to GMP Compliance Vol. III. Apr 21, 2017 7:00 am EDT. This product has been added to your shopping cart. You can continue shopping or proceed to checkout. Product Code: SPEQ1704. Member Price: $175.00. Non-member Price: $295.00. Become a member of IVT Network and get this product for free! Add to Cart. RESOLVING THE 3 TYPES OF VALIDATION EXCEPTIONS However, the type of exception that occurs needs to be recognized. Each classification of exception has different characteristics and will require different subsequent actions. Based off a presentation given by Brian Nunnally at Validation Week EU, there are three types of validation exceptions; simple, non-critical, and critical; eachwith
IVT NETWORK
IVT Network expands the global knowledge base for validation and compliance professionals in FDA regulated industries with educational publications, conferences, and more. PHASES OF A FUNCTIONAL RISK ASSESSMENT Phase 1. The severity of a fault is any impact on patient safety, product quality, or data integrity. Probability is the likelihood of the fault occurring at all. The relationship between the severity and probability is the risk class. There are numerous faults that can, and do, occur in a GMP environment that can be considered to have a low ULTRAFILTRATION AND DIAFILTRATION Ultrafiltration (UF) is a commonly used biotech process for concentrating a dilute product stream. UF separates molecules in solution based on the membrane pore size or molecular weight cutoff. Diafiltration (DF) is most often used to exchange product into a desired buffer (e.g., from an elution buffer into a final formulationbuffer) UF and DF
ICH Q9 (R1) QUALITY RISK MANAGEMENT REVISION A revision to ICH Q9 Quality Risk Management (QRM) has been recently approved by the ICH Management Committee (1). ICH Q9 is a key document associated with change management and validation. The original ICH Q9 was issued more than 10 years ago. Relevant documents associated with the approved revision project are linked below. ANTIMICROBIAL EFFECTIVENESS TESTING VALIDATION STRATEGIESSEE MORE ONIVTNETWORK.COM
CHANGE CONTROL FOR FUNCTIONALLY EQUIVALENT LIKE-FOR-LIKE At the other extreme, changes may be completely insignificant with minimal risk to patient, product, process, or equipment. Functionally equivalent (i.e., “like-for-like”) changes are often judged to be changes in this latter category. Like-for-like changes are minimal changes made to processes, equipment, utilities, facilities, computers DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status. MANUFACTURING DATE OF DRUG SUBSTANCES Hence, the retest date is assigned based on the manufacturing date and the retest period. Surprisingly, there is no regulation provided regarding the assignment of the manufacturing date of drug substance. Some stakeholders intentionally claim that the formation of the chemical core structure of a drug substance defines the manufacturingdate.
GAP ANALYSIS CHECKLIST FOR AN EQUIPMENT/SYSTEM/FACILITY Title: Gap Analysis Checklist for an Equipment/System/Facility Change Control Program Created Date: 6/5/2021 6:08:25 PM MAINTAINING QUALITY WHEN OUTSOURCING Outsourcing, or the use of contract service providers, has become a common practice in the pharmaceutical industry for a variety of reasons including lack of adequate in-house resources or other financial reasons. One means of controlling the quality of the outsourced product is through a contract or vendor agreement.IVT NETWORK
IVT Network expands the global knowledge base for validation and compliance professionals in FDA regulated industries with educational publications, conferences, and more. PHASES OF A FUNCTIONAL RISK ASSESSMENT Phase 1. The severity of a fault is any impact on patient safety, product quality, or data integrity. Probability is the likelihood of the fault occurring at all. The relationship between the severity and probability is the risk class. There are numerous faults that can, and do, occur in a GMP environment that can be considered to have a low ULTRAFILTRATION AND DIAFILTRATION Ultrafiltration (UF) is a commonly used biotech process for concentrating a dilute product stream. UF separates molecules in solution based on the membrane pore size or molecular weight cutoff. Diafiltration (DF) is most often used to exchange product into a desired buffer (e.g., from an elution buffer into a final formulationbuffer) UF and DF
ICH Q9 (R1) QUALITY RISK MANAGEMENT REVISION A revision to ICH Q9 Quality Risk Management (QRM) has been recently approved by the ICH Management Committee (1). ICH Q9 is a key document associated with change management and validation. The original ICH Q9 was issued more than 10 years ago. Relevant documents associated with the approved revision project are linked below. ANTIMICROBIAL EFFECTIVENESS TESTING VALIDATION STRATEGIESSEE MORE ONIVTNETWORK.COM
CHANGE CONTROL FOR FUNCTIONALLY EQUIVALENT LIKE-FOR-LIKE At the other extreme, changes may be completely insignificant with minimal risk to patient, product, process, or equipment. Functionally equivalent (i.e., “like-for-like”) changes are often judged to be changes in this latter category. Like-for-like changes are minimal changes made to processes, equipment, utilities, facilities, computers DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status. MANUFACTURING DATE OF DRUG SUBSTANCES Hence, the retest date is assigned based on the manufacturing date and the retest period. Surprisingly, there is no regulation provided regarding the assignment of the manufacturing date of drug substance. Some stakeholders intentionally claim that the formation of the chemical core structure of a drug substance defines the manufacturingdate.
GAP ANALYSIS CHECKLIST FOR AN EQUIPMENT/SYSTEM/FACILITY Title: Gap Analysis Checklist for an Equipment/System/Facility Change Control Program Created Date: 6/5/2021 6:08:25 PM MAINTAINING QUALITY WHEN OUTSOURCING Outsourcing, or the use of contract service providers, has become a common practice in the pharmaceutical industry for a variety of reasons including lack of adequate in-house resources or other financial reasons. One means of controlling the quality of the outsourced product is through a contract or vendor agreement. WHAT’S IN A SITE MASTER VALIDATION PLAN? (FREE TEMPLATE The VMP should consist of a program description at the site along with chapters or individual validation master plans for each area of validation (e.g., process, equipment, cleaning, computer). Furthermore, it is a “living” document that should be continually updated for regulatory inspections and audits. A VMP site document isone of the
LIMITED ABILITY: UNDERSTANDING THE CONCERNS AROUND Dr. Tim Sandle Ph.D., is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. PHASES OF A FUNCTIONAL RISK ASSESSMENT Phase 1. The severity of a fault is any impact on patient safety, product quality, or data integrity. Probability is the likelihood of the fault occurring at all. The relationship between the severity and probability is the risk class. There are numerous faults that can, and do, occur in a GMP environment that can be considered to have a low A BASIC UNDERSTANDING OF DESIGN CONTROLS It is important for engineers to note that design controls are an integral part of making any device; if done correctly, design controls can save companies and designers last minute redesign and possible recall. Design control consists of eight parts: general requirements, planning for design and development, design input, design output,design
QUALITY RISK MANAGEMENT Member Price: $175.00. Non-member Price: $195.00. Become a member of IVT Network and get this product for free! Add to Cart. It has been over years since the finalisation of ICH Q9, and this Specal Edition commemorates some of the greatest regulatory and industry thought leaders within the field of QRM. In this issue you will find elevenpapers
TEMPERATURE SCANNERS: LIMITED VALUE IN DETECTING EMPLOYEE A related limitation is the lack of a single agreed-upon upper limit for normal temperature among the medical community, with different opinions for bioregulation outside of the norm expressing values between 37.2 and 38.3°C for the onset of fever. Fevers do not typically go higher than 41 to 42°C. ICH Q9 (R1) QUALITY RISK MANAGEMENT REVISION A revision to ICH Q9 Quality Risk Management (QRM) has been recently approved by the ICH Management Committee (1). ICH Q9 is a key document associated with change management and validation. The original ICH Q9 was issued more than 10 years ago. Relevant documents associated with the approved revision project are linked below.AUDIT TRAIL
PURPOSE Describe the purpose or the intent of the audit. SCOPE Define the scope. What is the range of what you are attempting to accomplish. Out of Scope. Briefly define what is out of scope such as indicating “Non-GMP or Non-GxP systems or equipment. RESPONSIBILITY Define the responsibilities for those involved in this audit. DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status. FDA STORYTELLING—FDA INSPECTIONAL OBSERVATIONS & WARNING The following FDA Form 483 Inspectional Observations and FDA Warning Letter citations are examples of significant violations of current good manufacturing practice (cGMP) regulations for Finished Pharmaceuticals, Code of Federal Regulations Title 21 Parts 210 and 211, identified by FDA investigators at various companies. The purpose of this supplement is to review the compiledAUDIT TRAIL
PURPOSE Describe the purpose or the intent of the audit. SCOPE Define the scope. What is the range of what you are attempting to accomplish. Out of Scope. Briefly define what is out of scope such as indicating “Non-GMP or Non-GxP systems or equipment. RESPONSIBILITY Define the responsibilities for those involved in this audit. ROADMAP TO GMP COMPLIANCE VOL. III Roadmap to GMP Compliance Vol. III. Apr 21, 2017 7:00 am EDT. This product has been added to your shopping cart. You can continue shopping or proceed to checkout. Product Code: SPEQ1704. Member Price: $175.00. Non-member Price: $295.00. Become a member of IVT Network and get this product for free! Add to Cart. DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status. CHANGE CONTROL FOR FUNCTIONALLY EQUIVALENT LIKE-FOR-LIKE At the other extreme, changes may be completely insignificant with minimal risk to patient, product, process, or equipment. Functionally equivalent (i.e., “like-for-like”) changes are often judged to be changes in this latter category. Like-for-like changes are minimal changes made to processes, equipment, utilities, facilities, computers VALIDATION OF A CLEANING PROCESS FOR MEDICAL DEVICES The concepts described within this paper can be utilized by a medical device manufacturer to establish a cleaning process that will consistently provide clean medical devices and comply with the relevant regulations. Introduction Contamination of a medical device can have serious implications. This content is only available to IVTmembers.
CAPA AND THE CHANGE CONTROL PROCESS CAPA is a trigger that can be used to identify deficiencies in a change control process, stated Joseph Zec at IVT's 12th Annual Change Control conference. As Zec explained, a CAPA could be initiated as a result of executing a change request. There is a commonality between CAPA and change control, Zec continued, in that they are bothsystematic
RESOLVING THE 3 TYPES OF VALIDATION EXCEPTIONS MAINTAINING QUALITY WHEN OUTSOURCING Outsourcing, or the use of contract service providers, has become a common practice in the pharmaceutical industry for a variety of reasons including lack of adequate in-house resources or other financial reasons. One means of controlling the quality of the outsourced product is through a contract or vendor agreement.ALLAN MARINELLI
Allan Marinelli. Editorial Advisory Board, IVT Network. Allan Marinelli is currently the President of Quality Validation 360 Incorporated and has acquired over 25 years of experience within the Pharmaceutical, Medical Devices (Class 3), Vaccines, and Food/Beverage industries. His cGMP experience has cultivated expertise in qualityassurance
PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge AwitsAUDIT TRAIL
PURPOSE Describe the purpose or the intent of the audit. SCOPE Define the scope. What is the range of what you are attempting to accomplish. Out of Scope. Briefly define what is out of scope such as indicating “Non-GMP or Non-GxP systems or equipment. RESPONSIBILITY Define the responsibilities for those involved in this audit. ROADMAP TO GMP COMPLIANCE VOL. III Roadmap to GMP Compliance Vol. III. Apr 21, 2017 7:00 am EDT. This product has been added to your shopping cart. You can continue shopping or proceed to checkout. Product Code: SPEQ1704. Member Price: $175.00. Non-member Price: $295.00. Become a member of IVT Network and get this product for free! Add to Cart. DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status. CHANGE CONTROL FOR FUNCTIONALLY EQUIVALENT LIKE-FOR-LIKE At the other extreme, changes may be completely insignificant with minimal risk to patient, product, process, or equipment. Functionally equivalent (i.e., “like-for-like”) changes are often judged to be changes in this latter category. Like-for-like changes are minimal changes made to processes, equipment, utilities, facilities, computers VALIDATION OF A CLEANING PROCESS FOR MEDICAL DEVICES The concepts described within this paper can be utilized by a medical device manufacturer to establish a cleaning process that will consistently provide clean medical devices and comply with the relevant regulations. Introduction Contamination of a medical device can have serious implications. This content is only available to IVTmembers.
CAPA AND THE CHANGE CONTROL PROCESS CAPA is a trigger that can be used to identify deficiencies in a change control process, stated Joseph Zec at IVT's 12th Annual Change Control conference. As Zec explained, a CAPA could be initiated as a result of executing a change request. There is a commonality between CAPA and change control, Zec continued, in that they are bothsystematic
RESOLVING THE 3 TYPES OF VALIDATION EXCEPTIONS MAINTAINING QUALITY WHEN OUTSOURCING Outsourcing, or the use of contract service providers, has become a common practice in the pharmaceutical industry for a variety of reasons including lack of adequate in-house resources or other financial reasons. One means of controlling the quality of the outsourced product is through a contract or vendor agreement.ALLAN MARINELLI
Allan Marinelli. Editorial Advisory Board, IVT Network. Allan Marinelli is currently the President of Quality Validation 360 Incorporated and has acquired over 25 years of experience within the Pharmaceutical, Medical Devices (Class 3), Vaccines, and Food/Beverage industries. His cGMP experience has cultivated expertise in qualityassurance
PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge Awits WHAT’S IN A SITE MASTER VALIDATION PLAN? (FREE TEMPLATE The VMP should consist of a program description at the site along with chapters or individual validation master plans for each area of validation (e.g., process, equipment, cleaning, computer). Furthermore, it is a “living” document that should be continually updated for regulatory inspections and audits. A VMP site document isone of the
LIMITED ABILITY: UNDERSTANDING THE CONCERNS AROUND Dr. Tim Sandle Ph.D., is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles.AUDIT TRAIL
PURPOSE Describe the purpose or the intent of the audit. SCOPE Define the scope. What is the range of what you are attempting to accomplish. Out of Scope. Briefly define what is out of scope such as indicating “Non-GMP or Non-GxP systems or equipment. RESPONSIBILITY Define the responsibilities for those involved in this audit. STERILE OPHTHALMIC PREPARATIONS AND CONTAMINATION CONTROL Ophthalmic preparations are sterile liquid, semi-solid, or solid preparations intended for application to the conjunctiva, the conjunctival sac, or the eyelids. Sterility is a key issue in manufacture and use of ophthalmic products. Preservative selection is a critical activity in product design. Other important aspects requiring assessment in PROCESS PERFORMANCE—CONFORMANCE LOTS This approach includes process understanding derived from laboratory studies and process development history, confirmatory process performance at commercial scale using specified process parameter values (conformance lots), and maintenance of the validated state during routine manufacturing by ongoing process monitoring. A QUALITY RISK MANAGEMENT APPROACH FOR QUALIFICATION AND For commissioning and qualification of facilities, utilities, and equipment (F/U/E), a quality risk management approach can be used to identify and evaluate risk. The strategy will identify areas that will require more evaluation, adjustments, or re-design prior to implementation. Furthermore, it will provide controls to reduce riskto an
VALIDATION OF A CLEANING PROCESS FOR MEDICAL DEVICES The concepts described within this paper can be utilized by a medical device manufacturer to establish a cleaning process that will consistently provide clean medical devices and comply with the relevant regulations. Introduction Contamination of a medical device can have serious implications. This content is only available to IVTmembers.
AN ANATOMY OF A CONTAMINATION CONTROL STRATEGY FOR STERILE An effective strategy, depending on the type of pharmaceutical product being manufactured, considers (3, 4): Microbial contamination Sterility assurance Facility design Chemical contamination Particle contamination (visible and sub-visible) Viral control Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and CQV #2: "LIKE-FOR-LIKE" CHANGE PROBLEMS Validation and quality managers identified several types of “like-for-like” and associated problems –problems that should not happen. Interpretation. The definition of like-for-like is often too-broadly interpreted. The rationale -- “This really isn’t a change” – has been heard by validation and quality managersnumerous times.
PROCESS PERFORMANCE QUALIFICATION: SELECTING THE OPTIMAL Process validation is defined as the collection and evaluation of data from the process design stage through the commercial production that establishes scientific evidence that a process is capable of consistently delivering quality product and thereby also assuring reliability of supply.IVT NETWORK
IVT Network expands the global knowledge base for validation and compliance professionals in FDA regulated industries with educational publications, conferences, and more. QUALITY RISK MANAGEMENT ICH Q9 - A Critical Review, 2005-2015 It has been over years since the finalisation of ICH Q9, and this Special Edition commemorates som IMPLEMENTING QUALITY METRICS FOR VALIDATION Ivan Soto is the Director CQV at Emergent Biosolutions, he is responsible for leading the team responsible for commissioning, qualification and validation activities at the Canton Massachusetts manufacturing facility. MAINTAINING QUALITY WHEN OUTSOURCING Tim Fields is the Vice President of Quality at Protein Sciences Corporation Meriden, CT Mr. Fields joined Protein Sciences in 2010 as Director of Compliance and Training, and subsequently served as SeniorDirector of
GAP ANALYSIS CHECKLIST FOR AN EQUIPMENT/SYSTEM/FACILITY Title: Gap Analysis Checklist for an Equipment/System/Facility Change Control Program Created Date: 5/25/2021 1:08:08 PM AUDIT TRAILS REVIEWS FOR DATA INTEGRITY INTRODUCTION. Annex 11 requires that audit trails are regularly reviewed to ensure data integrity. There are a significant amount of inconsistent interpretations about the requirement to regularly reviewaudit trails.
DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT Birgitte Holst has worked for Novo Nordisk for more than 20 years, always with validation as a theme. Ms. Holst’s main experience hasbeen gathered in
INVESTIGATING AND ADDRESSING FUNGAL CONTAMINATION IN Introduction. There are different types of microorganisms associated with medicinal product recalls, as a review of recall notices indicates. One of the major reasons for recalls, aside from Gram-negative bacteria (which prompt the most common reason for microbiologically related recalls), is fungal contamination. PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge Awits USE OF HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCPSEE MORE ONIVTNETWORK.COM
IVT NETWORK
IVT Network expands the global knowledge base for validation and compliance professionals in FDA regulated industries with educational publications, conferences, and more. QUALITY RISK MANAGEMENT ICH Q9 - A Critical Review, 2005-2015 It has been over years since the finalisation of ICH Q9, and this Special Edition commemorates som IMPLEMENTING QUALITY METRICS FOR VALIDATION Ivan Soto is the Director CQV at Emergent Biosolutions, he is responsible for leading the team responsible for commissioning, qualification and validation activities at the Canton Massachusetts manufacturing facility. MAINTAINING QUALITY WHEN OUTSOURCING Tim Fields is the Vice President of Quality at Protein Sciences Corporation Meriden, CT Mr. Fields joined Protein Sciences in 2010 as Director of Compliance and Training, and subsequently served as SeniorDirector of
GAP ANALYSIS CHECKLIST FOR AN EQUIPMENT/SYSTEM/FACILITY Title: Gap Analysis Checklist for an Equipment/System/Facility Change Control Program Created Date: 5/25/2021 1:08:08 PM AUDIT TRAILS REVIEWS FOR DATA INTEGRITY INTRODUCTION. Annex 11 requires that audit trails are regularly reviewed to ensure data integrity. There are a significant amount of inconsistent interpretations about the requirement to regularly reviewaudit trails.
DEVELOPING A CLEANING PROCESS: CLEANING IN DEVELOPMENT Birgitte Holst has worked for Novo Nordisk for more than 20 years, always with validation as a theme. Ms. Holst’s main experience hasbeen gathered in
INVESTIGATING AND ADDRESSING FUNGAL CONTAMINATION IN Introduction. There are different types of microorganisms associated with medicinal product recalls, as a review of recall notices indicates. One of the major reasons for recalls, aside from Gram-negative bacteria (which prompt the most common reason for microbiologically related recalls), is fungal contamination. PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge Awits USE OF HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCPSEE MORE ONIVTNETWORK.COM
RISK-BENEFIT ANALYSIS OF THE FDA’S DECISION TO PAUSE J&J INTRODUCTION On April 23rd, the FDA and CDC released a joint statement lifting the recommended pause on the Johnson & Johnson (Janssen)COVID-19 V
THE JOURNAL OF GXP COMPLIANCE A case study involving unexpected green and brown spots on a previously problem-free white tablet product is described. Interaction between trace impurities in talc (formulation ingredient) and the tablet press punch lubricant, combined with worn dust cups used in the tablet compressing process were determined to be the causes of thespots.
APPROACHING MICROBIOLOGICAL METHOD VALIDATION With the above, a degree of interpretation is required. It follows: i) Method suitability: accuracy, precision and specificity (recovery of challenge organisms) for quantitative methods; for qualitative methods, only specificity would apply. ii) Robustness is assessed as above. It is not directly compared with a current method. Manufacturer’s data may be considered. APPLICATION OF GMP IN THE CANNABIS INDUSTRY ABSTRACT. Many European Union (EU) countries have legalized or decriminalized the medical use of cannabis to some degree. The advent of broad acceptance of medical cannabis as public opinion shifts in the EU is driving the need for the cannabis industry to implement strict regulatory controls on the production of cannabis products.AUDIT TRAIL
PURPOSE Describe the purpose or the intent of the audit. SCOPE Define the scope. What is the range of what you are attempting to accomplish.Out of Scope.
STERILE OPHTHALMIC PREPARATIONS AND CONTAMINATION CONTROL Dr. Tim Sandle Ph.D., is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. MANUFACTURING DATE OF DRUG SUBSTANCES ABSTRACT. The pharmaceutical industry is a very competitive field where human safety plays a superior role. For this reason, highstandards for
GOOD HYGIENIC DESIGN PRINCIPLES FOR PHARMACEUTICAL Dr. Tim Sandle Ph.D., is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles.RENEE PHILLIPS
Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. RISK ANALYSIS AND ORDINAL RISK RATING SCALES—A CLOSER LOOK ABSTRACT. This paper offers practical advice on how to improve the risk analysis portion of the QRM lifecycle, with particular attention paid to the typical ordinal risk rating scales that are used duringrisk analysis.
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4.0 - The next revolution Posted: Nov 12 2019 - 10:42 am On today's episode, Stacey Bruzzese welcomes Karen Ginsbury to talk about Pharma 4.0. Discussing a variety of topics, listen to discover what exactly is Pharma 4.0, and how will it impact the...0 comments
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NEXT INDUSTRIAL REVOLUTION – PHARMA 4.0 Posted: Nov 8 2019 - 12:34 pm Karen Ginsbury recently guested on Voices in Validation podcast and shared her insights on the pharmaceutical industry and the implementation of prevailing technologies. Traditionally anindustry...
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of a Riboprinter® for Microbiological Control... Posted: Nov 20 2019 - 11:12 am This article outlines the Riboprinting technology and discusses some applications of the approach, which can assist within investigations within the pharmaceutical context.0 comments
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Manufacturing Practices (GMP) Approach to Post-Harvest... Posted: Nov 20 2019 - 4:29 pm This article provides guidance on GMP considerations that must be made when conducting trimming, drying, and curing processes for cannabis production, as well as providing highlights to operational...0 comments
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Adult Learning Principles, CGMP Training Modalities... Posted: Sep 16 2019 - 12:02 pm In this first article, we consider whether our CGMP learning programs providing the benefits that we are seeking; with effective knowledge transfer relevant to the adult learner in the CGMP...0 comments
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