The long awaited EU GDP Guideline was published in the Official Journal of the European Union by EU Commission on 7 March 2013. This document will replace the current GDP Guideline published in 1994 (94/C 63/03).
The structure of the final document has been aligned with the structure of the EU GMP Guidelines, now including 10 chapters:
- Chapter 1 Quality Management.
- Chapter 2 Personnel
- Chapter 3 Premises and Equipment
- Chapter 4 Documentation
- Chapter 5 Operations
- Chapter 6 Complaints, Returns, Suspected Falsified Medicinal Products and
Medicinal Product Recalls
- Chapter 7 Outsourced Activities
- Chapter 8 Self-Inspections
- Chapter 9 Transportation
- Chapter 10 Specific Provisions for Brokers
A copy of the guidelines can be downloaded here: GDP GuIdelines fromofficial EU Journal