Good Manufacturing Practices (3rd Edition) - Regulatory Issues

Good Manufacturing Practices (3rd Edition)
Published Date: July 2006
Published By: Drug and Market Development Publishing
Page Count: 423
Order Code: R294-212
$795 Online Download
Chapter 1: Executive Summary
Chapter 2: Introduction
Quality Assurance in Drug Manufacturing & Testing
Corporate Responsibility for GMP Compliance
The Cost of Non-Compliance
Chapter 3: International Regulations Governing GMP
Chronology and Current Regulations
USA
Canada
Japan
International Conference on Harmonization
European Union
World Health Organization
Comparison of the Regulations
Differences between Regulations
Definitions
Chapter 4: Standard Operating Procedures
What are Standard Operating Procedures?
Guide to Writing SOPs
List of Basic SOPs for All Facilities
Subpart B: Organization & Personnel
Subpart C: Buildings and Facilities
Subpart D: Equipment
Subpart E: Control of Components and Drug Product Containers and Closures
Subpart F: Production and Process Controls
Subpart G: Packaging and Labeling Control
211.122. Materials examination and usage criteria
Subpart H: Holding and Distribution
Subpart I: Laboratory Controls
Subpart J: Records and Reports
Subpart K: Returned and Salvaged Drug Products
211.204. Returned drug products
Subpart L: Validation (Proposed 1996 Addition)
Subpart M: Contamination (Proposed 1996 Addition)
Chapter 5: Validation of Procedures, Processes, and Methods
What is Validation?
Process Analytical Technology (PAT) and Validation
The Validation Master Plan
Validation Master Plan Contents
Creating the Validation Protocols
Process Validation
Method Validation
Guide to the Performance of Validations
Points to Consider in Selected Validations
Purified Water Systems
Cleaning Procedures
Sterilization Procedures
Fermentor and Bioreactor Control
Chromatographic Separation
Computerized Systems
Chapter 6: Critical Compliance Issues for Active Principal Ingriedients
and Drug Products
Organization and Personnel (Subpart B, ?211.22 - 34)
Buildings and Facilities (Subpart C, 211.42 - 58)
Equipment (Subpart D, ?211.63 - 72)
Control of Components, Containers & Closures (Subpart E, ?211.80 -94)
Production and Process Controls (Subpart F, ?211.100 - 115)
Packaging and Labeling Controls (Subpart G, ?211.122 - 137)
Holding and Distribution (Subpart H, ?211.142 - 150)
Laboratory Controls (Subpart I, ?211.160 - 173)
Notes on the Validation of Analytical Test Methods
Note on Out-of-Specification.(OOS).Results
Records and Reports (Subpart J, ?211.180 - 198)
Note on Electronic Recordkeeping
Returns and Salvaged Drug Products (Subpart K, ?211.204 - 208)
Validation (New Subpart L, ?211.220 - 222)
Contamination (Subpart M, ? 211.240)
Chapter 7: Critical Compliance Issues for Biologicals
Establishment Standards (Subpart B, ?600.10 - 15)
Personnel.(?600.10)
Physical Establishment,.Equipment, Animals & Care.(?600.11)
Air Quality Specifications for Clean Rooms
Aseptic Processing of Sterile Products
Facilities
Operations
Training
Other Topics
Records and Retention of Samples.(?600.12)
Reporing of Deviations.(?600.14)
Control of Product Temperature during Shipment.(?600.15)
Other Regulatory Agencies
Chapter 8: Preparation of ICH Manufacturing Documentation
The CMC Section According to FDA
ICH Modules 2 and 3
Chapter 9: Internal and External Inspections
Internal QA Inspections and Audits
Self-inspections
Internal audits
Regulatory Inspections - FDA?s New ?Six Systems? Approach
Establishment Inspections - the Six Systems Approach
Surveillance and Compliance Inspections
Critical Aspects of Inspections
The Quality System
Facilities and Equipment System
Materials System
Production System
Packaging and Labeling Control
Laboratory Control System
Quality System:
Facilities and Equipment
Materials System
Production System
Packaging and Labeling
Laboratory Control System
How to Survive Inspections
Preparing for the inspection
Inspection Days
Dealing with Inspection Reports
The Most Common Form 483 Comments
FDA Enforcement Procedures
Chapter 10: Conclusions
Chapter 11: References and Further Reading
Access to Regulatory Documents
Regulatory, Validation and Inspection Guides USA
Canada
European Union
ICH
Advisory Bodies, Publications and other Web Sites
Chapter 12: Appendices
Forms for the Performance of Internal Inspections
Texts of Regulations and Selected Guidelines
USA
Canada
Japan
The European Union
Guidance for Industry: Q8 Pharmaceutical Development
Guidance for Industry: Q9 Quality Risk Management
Table Of Exhibits
Exhibit 2.1 The Drug Development Pathway
Exhibit 2.2 What is Quality Assurance?
Exhibit 3.1 Revision to Japanese GMP Laws
Exhibit 3.2 Member Nations of the European Nations
Exhibit 3.3 Comparison of the Contents of GMP Regulations for Drug Products
Exhibit 3.4 Comparison of the Contents of Regulations for Biologicals
Exhibit 3.5 Definitions of Commonly Used Terms
Exhibit 4.1 Guide for SOP Form for a Manufacturing Process
Exhibit 4.2 SOP Form for a QC Test
Exhibit 5.1 Analytical Method Guidances
Exhibit 5.2 Process Validation and the Product Development Cycle
Exhibit 5.3 Typical ?System Definition? Table for a VMP
Exhibit 5.4 Validation Protocol Contents List
Exhibit 5.5 Control of a Cell Culture Bioreactor
Exhibit 5.6 Examples of Software Archived at the Audit Center
Exhibit 5.7 Product Codes Mentioned in 5.6
Exhibit 6.1 21CFR210/211 Regulations Relating to Management Responsibilities
Exhibit 6.2 Floor Plan of an Aseptic Fill/Finish Suite
Exhibit 6.3 Equipment Cleaning & Maintenance Log - Specimen Page
Exhibit 6.4 21CFR210/211 Regulations Relating to QSM Resources
Exhibit 6.5 Example of a Warehousing Label
Exhibit 6.6 Label for Raw Material/Packaging Sample
Exhibit 6.7 Label for a Dispensed Component
Exhibit 6.8 Label for In-process Material
Exhibit 6.9 Regulations Relating to Manufacturing Controls
Exhibit 6.10 Parameters for the Validation of Different Types of Analytical Method
Exhibit 6.11 Retention of Records
Exhibit 6.12 Regulations Relevant to Evaluation Issues
Exhibit 7.1 Diagram of a Laminar-flow Clean Room
Exhibit 7.2 Section Through a BL2/3 Aseptic Suite
Exhibit 7.3 Floor Plan of a Containment Animal Unit
Exhibit 7.4 Diagram of an Aseptic Filling/Lyophilization Suite
Exhibit 7.5 Clean Room Classifications
Exhibit 8.1 Diagrammatic Representation of the CTD
Exhibit 8.2 Module 2, The ?Quality? Portion of the Table of Contents
Exhibit 8.3 CTD Module 3 - Quality, Format of Contents