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* 21 CFR Part 820 API, Q8, Q9 & Q10
Sterile Drug Manufacturing

Medical Device Quality Systems Manual

Japanese GMPs

Sterile Medicinal Products
Biological Medicinal Products
Veterinary Medicinal Products
Manufacture of Medicinal Gases
Manufacture of Herbal Medicinal Products
Sampling of Starting and Packaging Materials
Manufacture of Liquids, Creams and Ointments
Pressurised Metered Dose Aerosol
EU Annex 11 Computerised Systems
Manufacture of Investigational Products
EU Annex 14 Human Blood or Human Plasma

ISO 13485
ISO 4971
Compounding 503b


* includes the GMP Basics 101 & 21 CFR Part 11 Electronic Systems

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