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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. 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge AwitsIVT 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 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge Awits 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. 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
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
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 APPLICATION OF GMP IN THE CANNABIS INDUSTRY 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. There is therefore a shift to implementation of GMP (Good Manufacturing Practices) in the cannabis space, most notably in CanadaAUDIT 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. VALIDATION COST REDUCTION Peer Reviewed: Validation Cost Reduction. Editor’s Note: This paper was originally submitted to the Journal of Validation Technology. We offer it to our JGXP readers for application in their quality and compliance organizations. Minimizing the cost 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.
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.
RISK ANALYSIS AND ORDINAL RISK RATING SCALES—A CLOSER LOOK 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 during risk analysis. Rating scales are criticality important in the risk process. A wealth of academic and industry literature exists that imply that ratingIVT 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 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge AwitsIVT 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 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge Awits 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. 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
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
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 APPLICATION OF GMP IN THE CANNABIS INDUSTRY 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. There is therefore a shift to implementation of GMP (Good Manufacturing Practices) in the cannabis space, most notably in CanadaAUDIT 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. VALIDATION COST REDUCTION Peer Reviewed: Validation Cost Reduction. Editor’s Note: This paper was originally submitted to the Journal of Validation Technology. We offer it to our JGXP readers for application in their quality and compliance organizations. Minimizing the cost 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.
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.
RISK ANALYSIS AND ORDINAL RISK RATING SCALES—A CLOSER LOOK 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 during risk analysis. Rating scales are criticality important in the risk process. A wealth of academic and industry literature exists that imply that ratingIVT 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 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge AwitsIVT 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 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge Awits 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. 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
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
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 APPLICATION OF GMP IN THE CANNABIS INDUSTRY 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. There is therefore a shift to implementation of GMP (Good Manufacturing Practices) in the cannabis space, most notably in CanadaAUDIT 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. VALIDATION COST REDUCTION Peer Reviewed: Validation Cost Reduction. Editor’s Note: This paper was originally submitted to the Journal of Validation Technology. We offer it to our JGXP readers for application in their quality and compliance organizations. Minimizing the cost 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.
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.
RISK ANALYSIS AND ORDINAL RISK RATING SCALES—A CLOSER LOOK 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 during risk analysis. Rating scales are criticality important in the risk process. A wealth of academic and industry literature exists that imply that ratingIVT 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 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge AwitsIVT 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 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
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
IMPLEMENTING QUALITY METRICS FOR VALIDATION Quality validation metrics are those metrics that provide an assessment and measurement of the quality of the validation program. The quality of the validation program can be defined as the ability to execute the process with the highest level of quality. The quality of the validation program also includes the ability to meet the intent ofthe
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 trailRENEE PHILLIPS
Renee Phillips. Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs atJohnson
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. VALIDATION OF THE GROWTH DIRECT SYSTEM TO PERFORM Abstract. The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates. The validation strategy conforms to the recently updated USP Ch 1 and sample data are given to demonstrate that the 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 PROCESS PERFORMANCE CONFORMANCE LOTS NETWORK INSTITUTE OF VALIDATION TECHNOLOGY NETWORK I INSTITUTE OF VALIDATION TECHNOLOGY business Unlimited Validation Knowledge Awits 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. 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
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
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 APPLICATION OF GMP IN THE CANNABIS INDUSTRY 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. There is therefore a shift to implementation of GMP (Good Manufacturing Practices) in the cannabis space, most notably in CanadaAUDIT 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. VALIDATION COST REDUCTION Peer Reviewed: Validation Cost Reduction. Editor’s Note: This paper was originally submitted to the Journal of Validation Technology. We offer it to our JGXP readers for application in their quality and compliance organizations. Minimizing the cost 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.
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.
RISK ANALYSIS AND ORDINAL RISK RATING SCALES—A CLOSER LOOK 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 during risk analysis. Rating scales are criticality important in the risk process. A wealth of academic and industry literature exists that imply that rating Sign In | Become a memberShopping Cart:
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Essentials of Designing for Manufacturability Posted: Mar 5 2020 - 2:35 pm This week on Voices in Validation we will be covering the essentials of designing for manufacturability. Roberta Goode provides an overview of the details necessary in DFM, breaking it down to an...0 comments
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1 Draft Revision and Stakeholder Comment Period Posted: Mar 17 2020 - 8:48 am Annex 1 was first published in 1971, to ensure sterility of medicinal products for the benefits of patients. Now is the first time its under a complete review. According to the European...0 comments
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Trails and Data Integrity in Pharmaceutical and Life Sciences Posted: Jan 28 2020 - 10:00 am On today's episode we invited Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions, to help us cover a variety of aspects around the topic of data integrity.0 comments
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Integrity: Hidden Issues and Blind Spots Posted: Jan 28 2020 - 10:06 am On today's episode of Voices in Validation we catch up with Dr. Siegfried Schmitt, in his home office to discuss hidden issues sometimes hiding in plain sight, and how to avoid blind spots when...0 comments
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Annex 1 – Revision 2 Draft Update Brief Posted: Feb 28 2020 - 11:57 am The long-awaited revision to the EU Annex 1 draft documents has caused much excitement in the world of regulated industry. In drafting the revision, the EC worked closely with the World Health...0 comments
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