ABSTRACT
The main body of the text of the EC Guide is presented in nine chapters, approximately (but not precisely) in line with the Principles of the corresponding EC Directive 91/356. The chapter headings of the EC GMP Guide are:
Chapter 1 Quality Management Chapter 2 Personnel Chapter 3 Premises and Equipment Chapter 4 Documentation Chapter 5 Production Chapter 6 Quality Control Chapter 7 Contract Manufacture and Analysis Chapter 8 Complaints and Product Recall Chapter 9 Self Inspection
These nine chapters are followed by 18 annexes as follows:
1. Manufacture of Sterile Medicinal Products 2. Manufacture of Biological Medicinal Products for Human Use 3. Manufacture of Radiopharmaceuticals 4. Manufacture of Veterinary Medicinal Products other than Immunologicals 5. Manufacture of Immunological Veterinary Medicinal Products 6. Manufacture of Medicinal Gases 7. Manufacture of Herbal Medicinal Products 8. Sampling of Starting and Packaging Materials 9. Manufacture of Liquids, Creams and Ointments
10. Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
11. Computerised Systems 12. Use of Ionising Radiation in the Manufacture of Medicinal Products 13. Manufacture of Investigational Medicinal Products 14. Manufacture of Products derived from Human Blood or Human Plasma 15. Qualification and Validation 16. Certification by a Qualified Person and Batch Release 17. Parametric Release 18. Good Manufacturing Practice for Active Pharmaceutical Ingredients
The US cGMPs for Finished Pharmaceutical Products are in two parts: 21 CFR Part 210 General, which deals with such matters as status, applicability, and definitions of terms; and 21 CFR Part 211, which contains the specific “meat” of the cGMPs. This Part 211 has 11 subparts:
A. General Provisions B. Organization and Personnel C. Buildings and Facilities D. Equipment E. Control of Componentsand Drug Product Containers and Closures F. Production and Process Controls G. Packaging and Labelling Control H. Holding and Distribution I. Laboratory Controls J. Records and Reports K. Returned and Salvaged Drug Products
The following is intended only as a summary of significant differences and similarities:
The EC Guide, reflecting the European mandatory requirement (Directive 91/356) for the independence of Quality Control states that “the heads of Production and Quality Control must independent from each other.” The US cGMPs do not appear specifically to require this separation of responsibility and authority, although it is perhaps implicit in the statements on the responsibility and authority of the “Quality Control Unit” that appear in 211.22. In any event, this separation does seem to be standard practice in US pharmaceutical manufacturing companies.
