Features:

• Provides comprehensive coverage of the US and EU group requirements
• Presents similarities and differences of each regulation in tabular format
• Offers practical methods, based on experience, for implementation and compliance
• Covers personnel and facilities management as well as manufacturing

Bridging the gap between US and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance comparatively presents the major substance of both the "US Current Good Manufacturing Practice for Finished Pharmaceutical Regulations" and the European "Guide to Good Manufacturing Practice for Medicinal Products."

It explores the reasoning behind the requirements and the ways and means of complying with them. Topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Contents

1. Introduction - Status and Applicability of US Regulations/EU Guidelines - General Quality Issues
2. Personnel, Organization and Training
3. Premises/Buildings and Facilities
4. Contamination and Contamination Control
5. Equipment
6. Materials Control
7. Production and Process Controls
8. Packaging and Labeling Control
9. Holding and Distribution
10. Laboratory Controls
11. Records and Reports
12. Returned and Salvaged Products
13. Sterile Products Manufacture - Basic principles
14. GMP and Quality Assurance in Sterile Products Manufacture
15. Validation - General Principles
16. Validation - Applications
17. Self-inspection and Quality Audit
18. UScGMPs and EC GMP Guide - Concluding Comparison

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