In Europe, the implementation of GMP is laid down in Directive 2003/94 and in the EU GMP Guide (incl. Annexes). Annex 11 "Computerised Systems" was revised in January 2011 together with Chapter 4 of the EU GMP Guide. Both documents must be implemented by the pharmaceutical industry by 30 June 2011.
The EMA (European Medicines Agency) has just published answers to questions on computerised systems under "Q&A: Good Manufacturing Practices (GMP)".
Here are the main topics:
- Requirements for spreadsheets
- Data security of databases
- Risk management in the system lifecycle
- Use requirements as part of the retrospective validation of legacy systems
- Revalidation of computerised systems
- Storage time of electronic data and documents
- Validation efforts for small devices
- Alternative controls in case a system is not capable to generate printouts
Please see the detailed questions and answers.
Dr Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)