EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines.
- Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
- Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.
- Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Part I – Basic Requirements for Medicinal Products
- Chapter 1 Quality Management (revision February 2008)
- Chapter 2 Personnel
- Chapter 3 Premise and Equipment
- Chapter 4 Documentation (Revision January 2011) – Coming into operation by 30 June 2011
- Chapter 5 Production
- Chapter 6 Quality Control
- Chapter 7 Contract Manufacture and Analysis
- Chapter 8 Complaints and Product Recall
- Chapter 9 Self Inspection
Part II – Basic Requirements for Active Substances used as Starting Materials
Part III – GMP related documents
- Site Master File
- Q9 Quality Risk Management
- Q10 Note for Guidance on Pharmaceutical Quality System
- MRA Batch Certificate
Basic Principles of GMP Introduction to the training course Quality management Sanitation and hygiene Qualification and Validation Complaints and recalls Contract production and analysis Self-inspection and Quality Audits Personnel Premises Equipment Materials Documentation Good Practices in Production and Quality Control Sterile production Active Pharmaceutical Ingredient
GMP Inspection Process Introduction The role of the inspector Preparation for an inspection Types of GMP inspection The inspection