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
Basic Principles of GMP
Introduction to the training course
Sanitation and hygiene
Qualification and Validation
Complaints and recalls
Contract production and analysis
Self-inspection and Quality Audits
Good Practices in Production and Quality Control
Active Pharmaceutical Ingredient
GMP Inspection Process
The role of the inspector
Preparation for an inspection
Types of GMP inspection