EU - Good manufacturing practice (GMP) Guidelines Titles

EU - Good manufacturing practice (GMP) Guidelines Titles

 

Part I - Basic Requirements for Medicinal Products

·       Chapter 1  - Pharmaceutical Quality System

·       Chapter 2  - Personnel

·       Chapter 3  - Premises & Equipment

·       Chapter 4  - Documentation

·       Chapter 5  - Production

·       Chapter 6  - Quality Control

·       Chapter 7  - Out sourced activities

·       Chapter 7  - Contract Manufacture & Analysis

·       Chapter 8  - Compliance & Product Recall

·       Chapter 9  - Self Inspection

Part II - Basic Requirements for Medicinal Products

·       Basic Requirements for Active substances used as starting materials

Part III – GMP Related documents

·       Explanatory notes on the preparation of a site master file

·       Q9 Quality Risk Management

·       Q10 Note for guidance on Pharmaceutical Quality System

·       MRA Batch Certificate

·       Template for the written confirmation for active substances exported to European union for medicinal product for human use

Annexures

·       Annexure-1 Manufacture of sterile medicinal products

·       Annexure-2 Manufacture of biological active substances and medicinal products for human use

·       Annexure-3 Manufacture of Radiopharmaceuticals

·       Annexure-4 Manufacture of Veterinary medicinal products other than immunological veterinary medicinal products

·       Annexure-5 Manufacture of Immunological Veterinary medicinal products

·       Annexure-6 Manufacture of Medicinal Gases

·       Annexure-7 Manufacture of Herbal Medicinal Products

·       Annexure-8 Sampling of starting & Packaging Materials

·       Annexure-9 Manufacture of liquids, creams and ointments

·       Annexure-10 Manufacture of pressurised metered dose aerosol preparations for inhalation

·       Annexure-11 Computerised Systems

·       Annexure-12 Use of Ionizing radiation in the manufacture of medicinal products

·       Annexure-13 Manufacture of investigational medicinal products

·       Annexure-14 Manufacture of medicinal products derived from human blood or plasma

·        Annexure-15 Qualification & Validation

·       Annexure-16 Certification by a qualified person and batch release

·       Annexure-17 Parametric  release

·       Annexure-19  Reference & retention Samples