Cleaning Validation
portes grátis
Cleaning Validation
Practical Compliance Approaches for Pharmaceutical Manufacturing
LeBlanc, Destin A.
Taylor & Francis Ltd
12/2022
204
Dura
Inglês
9781032430836
15 a 20 dias
557
Descrição não disponível.
Terminology
Use of the Term "Product"
Use of the Terms Grouping and Matrixing
Deviations and Nonconformances
Clarifying Terms: Blanks vs. Controls
Meaning of "Dedicated"?
Words (Again??)
Health-based Limits
What's at Stake with HBELs
A Look at the Revised Risk-MaPP
EMA's Q&A Clarification: Part 1
EMA's Q&A Clarification: Part 2
The EMA Q&A "Clarification" on Limits
The EMA Q&A on Routine Analytical Testing
Other Issues in EMA's Q&A
Highly Hazardous Products in Shared Facilities
Limits - General
EMA vs. ISPE on Cleaning Limits?
Does a High "Margin of Safety" Protect Patients?
What If the Next Product is the Same Product?
Limits for "Product A to Product A"
Surfaces Areas in Carryover Calculations
Carryover Calculation Errors to Avoid
Protocol Limits for Yeasts/Molds?
Cleaning Validation for Homeopathic Drug Products
A Possible Approach for Biotech Limits
Establishing Clearance for Degraded Protein Actives
Visually Clean
Avoiding "Visually Dirty" Observations
What's a Visual Limit?
Visual Residue Limits - Part 1
Visual Residue Limits - Part 2
Analytical and Sampling Methods
Two More Nails in the Coffin?
More Swab Sampling Issues
Timing for Swab Sampling in a Protocol?
Pass/Fail Analytical Test Methods
Product Grouping
Issues in Product Grouping
Toxicity as a Worst-Case Grouping Factor
Another "Worst Case" Product Grouping Idea
Protocols and Procedures
Issues in Rinsing - Part 1
Issues in Rinsing - Part 2
Routine Monitoring for Highly Hazardous Products
"Concurrent Release" for Cleaning Validation
Dirty and Clean Hold Time Protocols
API Manufacture
A Critique of the APIC Guideline
Another Issue for API Synthesis
Contaminants in API Manufacture
Miscellaneous
Significant Figures: Back to Basics
The Value of a Protocol Worksheet for Manual Cleaning
Dealing with Used and New Equipment
Solving Cleaning Validation Problems by Analogy
Causing Cleaning Validation Problems by Analogy
Appendix A: Acronyms Used in this Volume
Appendix B: Shorthand Notations for Expressing Limits
Index
Use of the Term "Product"
Use of the Terms Grouping and Matrixing
Deviations and Nonconformances
Clarifying Terms: Blanks vs. Controls
Meaning of "Dedicated"?
Words (Again??)
Health-based Limits
What's at Stake with HBELs
A Look at the Revised Risk-MaPP
EMA's Q&A Clarification: Part 1
EMA's Q&A Clarification: Part 2
The EMA Q&A "Clarification" on Limits
The EMA Q&A on Routine Analytical Testing
Other Issues in EMA's Q&A
Highly Hazardous Products in Shared Facilities
Limits - General
EMA vs. ISPE on Cleaning Limits?
Does a High "Margin of Safety" Protect Patients?
What If the Next Product is the Same Product?
Limits for "Product A to Product A"
Surfaces Areas in Carryover Calculations
Carryover Calculation Errors to Avoid
Protocol Limits for Yeasts/Molds?
Cleaning Validation for Homeopathic Drug Products
A Possible Approach for Biotech Limits
Establishing Clearance for Degraded Protein Actives
Visually Clean
Avoiding "Visually Dirty" Observations
What's a Visual Limit?
Visual Residue Limits - Part 1
Visual Residue Limits - Part 2
Analytical and Sampling Methods
Two More Nails in the Coffin?
More Swab Sampling Issues
Timing for Swab Sampling in a Protocol?
Pass/Fail Analytical Test Methods
Product Grouping
Issues in Product Grouping
Toxicity as a Worst-Case Grouping Factor
Another "Worst Case" Product Grouping Idea
Protocols and Procedures
Issues in Rinsing - Part 1
Issues in Rinsing - Part 2
Routine Monitoring for Highly Hazardous Products
"Concurrent Release" for Cleaning Validation
Dirty and Clean Hold Time Protocols
API Manufacture
A Critique of the APIC Guideline
Another Issue for API Synthesis
Contaminants in API Manufacture
Miscellaneous
Significant Figures: Back to Basics
The Value of a Protocol Worksheet for Manual Cleaning
Dealing with Used and New Equipment
Solving Cleaning Validation Problems by Analogy
Causing Cleaning Validation Problems by Analogy
Appendix A: Acronyms Used in this Volume
Appendix B: Shorthand Notations for Expressing Limits
Index
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Microbiology;Cleaning validation protocol;Quality assurance;Grouping and matrixing;Hazardous materials;Health-based limits
Terminology
Use of the Term "Product"
Use of the Terms Grouping and Matrixing
Deviations and Nonconformances
Clarifying Terms: Blanks vs. Controls
Meaning of "Dedicated"?
Words (Again??)
Health-based Limits
What's at Stake with HBELs
A Look at the Revised Risk-MaPP
EMA's Q&A Clarification: Part 1
EMA's Q&A Clarification: Part 2
The EMA Q&A "Clarification" on Limits
The EMA Q&A on Routine Analytical Testing
Other Issues in EMA's Q&A
Highly Hazardous Products in Shared Facilities
Limits - General
EMA vs. ISPE on Cleaning Limits?
Does a High "Margin of Safety" Protect Patients?
What If the Next Product is the Same Product?
Limits for "Product A to Product A"
Surfaces Areas in Carryover Calculations
Carryover Calculation Errors to Avoid
Protocol Limits for Yeasts/Molds?
Cleaning Validation for Homeopathic Drug Products
A Possible Approach for Biotech Limits
Establishing Clearance for Degraded Protein Actives
Visually Clean
Avoiding "Visually Dirty" Observations
What's a Visual Limit?
Visual Residue Limits - Part 1
Visual Residue Limits - Part 2
Analytical and Sampling Methods
Two More Nails in the Coffin?
More Swab Sampling Issues
Timing for Swab Sampling in a Protocol?
Pass/Fail Analytical Test Methods
Product Grouping
Issues in Product Grouping
Toxicity as a Worst-Case Grouping Factor
Another "Worst Case" Product Grouping Idea
Protocols and Procedures
Issues in Rinsing - Part 1
Issues in Rinsing - Part 2
Routine Monitoring for Highly Hazardous Products
"Concurrent Release" for Cleaning Validation
Dirty and Clean Hold Time Protocols
API Manufacture
A Critique of the APIC Guideline
Another Issue for API Synthesis
Contaminants in API Manufacture
Miscellaneous
Significant Figures: Back to Basics
The Value of a Protocol Worksheet for Manual Cleaning
Dealing with Used and New Equipment
Solving Cleaning Validation Problems by Analogy
Causing Cleaning Validation Problems by Analogy
Appendix A: Acronyms Used in this Volume
Appendix B: Shorthand Notations for Expressing Limits
Index
Use of the Term "Product"
Use of the Terms Grouping and Matrixing
Deviations and Nonconformances
Clarifying Terms: Blanks vs. Controls
Meaning of "Dedicated"?
Words (Again??)
Health-based Limits
What's at Stake with HBELs
A Look at the Revised Risk-MaPP
EMA's Q&A Clarification: Part 1
EMA's Q&A Clarification: Part 2
The EMA Q&A "Clarification" on Limits
The EMA Q&A on Routine Analytical Testing
Other Issues in EMA's Q&A
Highly Hazardous Products in Shared Facilities
Limits - General
EMA vs. ISPE on Cleaning Limits?
Does a High "Margin of Safety" Protect Patients?
What If the Next Product is the Same Product?
Limits for "Product A to Product A"
Surfaces Areas in Carryover Calculations
Carryover Calculation Errors to Avoid
Protocol Limits for Yeasts/Molds?
Cleaning Validation for Homeopathic Drug Products
A Possible Approach for Biotech Limits
Establishing Clearance for Degraded Protein Actives
Visually Clean
Avoiding "Visually Dirty" Observations
What's a Visual Limit?
Visual Residue Limits - Part 1
Visual Residue Limits - Part 2
Analytical and Sampling Methods
Two More Nails in the Coffin?
More Swab Sampling Issues
Timing for Swab Sampling in a Protocol?
Pass/Fail Analytical Test Methods
Product Grouping
Issues in Product Grouping
Toxicity as a Worst-Case Grouping Factor
Another "Worst Case" Product Grouping Idea
Protocols and Procedures
Issues in Rinsing - Part 1
Issues in Rinsing - Part 2
Routine Monitoring for Highly Hazardous Products
"Concurrent Release" for Cleaning Validation
Dirty and Clean Hold Time Protocols
API Manufacture
A Critique of the APIC Guideline
Another Issue for API Synthesis
Contaminants in API Manufacture
Miscellaneous
Significant Figures: Back to Basics
The Value of a Protocol Worksheet for Manual Cleaning
Dealing with Used and New Equipment
Solving Cleaning Validation Problems by Analogy
Causing Cleaning Validation Problems by Analogy
Appendix A: Acronyms Used in this Volume
Appendix B: Shorthand Notations for Expressing Limits
Index
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
