Site Master File – EU GMP
EU GMP Guidelines for Site Master File of Pharmaceuticals | Preparation of a Site Master File of Pharmaceuticals as per EU GMP Guidelines |
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Guidelines
21 CFR Part 211-cGMP
21 CFR Part 211—Current Good Manufacturing Practice For Finished Pharmaceuticals | 21 CFR Part 211 USFDA Guidelines For Pharmaceuticals |
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Containers-Glass
USP General Chapter 660 Containers – Glass | Types of Glass Containers Used In Pharmaceuticals | Glass Vial Testing as Per USP |
Self Inspection – EU GMP
EU GMP Guidelines for Self Inspection
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Complaints and Product Recalls – EU GMP
EU GMP Guidelines for Complaints, Quality Defects and Product Recalls
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Outsourced Activities – EU GMP
EU GMP Guidelines for Outsourced Activities (Contract Laboratory Analysis)
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Production – EU GMP
EU GMP Guidelines for Production | EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use |
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Documentation – EU GMP
EU GMP Guidelines for Documentation | EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use |
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Premises and Equipment – EU GMP
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use | EU GMP Guidelines for Premises and Equipment |
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Personnel – EU GMP
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use | EU GMP Guidelines for Personnel |
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