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Good Manufacturing Practices (3rd Edition)

Drug and Market Development Publishing
July 1, 2006
423 Pages - SKU: DSMD1317950

Abstract Table of Contents Search inside this report Related Reports

D&MD's updated Good Manufacturing Practices professional development guide provides pharmaceutical and biological companies of all sizes with assistance in regulatory compliance. The guide examines the new FDA Guidance for Industry documents and a new amendment covering an exemption for investigational drugs in Phase 1 studies. The guide is addressed particularly to smaller sized companies, perhaps those with their first new drug, working on this extra challenge to their capabilities.

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; 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
Chapter 5: Validation of Procedures, Processes, and Methods: What is Validation?; Process Analytical Technology (PAT) and Validation; The Validation Master Plan; Creating the Validation Protocols; Guide to the Performance of Validations; Points to Consider in Selected Validations
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); Records and Reports (Subpart J, §211.180 - 198); 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); 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; Regulatory Inspections - FDA’s New “Six Systems” Approach; Critical Aspects of Inspections; How to Survive Inspections
Chapter 10: Conclusions
Chapter 11: References and Further Reading: Access to Regulatory Documents; Regulatory, Validation and Inspection Guides USA; Advisory Bodies, Publications and other Web Sites
Chapter 12: Appendices: Forms for the Performance of Internal Inspections; Texts of Regulations and Selected Guidelines
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

Good Manufacturing Practices (3rd Edition)

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