EU GMP Annex 11
Better manufacturing practices
The good manufacturing practice (GMP) guidelines first published in 1989 by the European Union (EU) described a set of process standards to be met by manufacturers of drugs and medicines for production and/or sale within EU markets. Since then, the scope of EU GMP guidelines has grown with a series of additions to the original document, annexed as needed to address advances in technology and a changing pharmaceutical industry landscape.
New guidance for a digital age
Annex 11: Computerized Systems was added and periodically revised in response to increased computer-mediated control over production systems, as well as the deepening complexity of these systems over time.
Annex 11 specifically defines what qualifies as a computerized system, emphasizing the need for validated, qualified application of such a system and the IT infrastructure that supports it. Aligning with basic EU GMP principles, this annex states that when a computerized system replaces a manual operation, there should be:
- No decrease in product quality
- No reduced level of process control
- No lowered standard of quality assurance
- No increase in overall risk associated with the product
Annex 11 presents a section of general guidance topics (risk management, personnel responsibilities, best practices among suppliers and service providers), followed by more detailed guidelines for both the project and operational phases of computer system-mediated medicine production (partial list):
- Validation: Manufacturers must justify production decisions based on risk assessment; documentation must include any deviations seen during validation; all relevant systems and their GMP functionality must be made available and kept up to date
- Data: Computerized systems exchanging data electronically should include appropriate built-in checks for the correct and secure entry and processing of data
- Evaluation: Ongoing computerized system evaluation should include functionality assessment, deviation records, problems, upgrade history, reliability and validation status reports
- Security: System access should be restricted to authorized users, by way of digital keys, pass cards, passwords, biometrics and restricted physical access to equipment and data storage areas
- Signatures: Electronic records may be signed digitally, provided electronic signatures are time-stamped, permanently linked with their respective records, and have the same impact as handwritten signatures
Note that, aside from the focus on computerized control of pharmaceutical production systems, every aspect of Annex 11 remains in service of long-standing EU GMP requirements that medicines:
- Are of consistent high quality
- Are appropriate for their intended use
- Meet all requirements of marketing or clinical trial authorization
“Good Manufacturing Practice.” GMP Training, GMP Guidelines, GMP Trends - ECA Academy, https://www.gmp-compliance.org/files/guidemgr/annex11_01-2011_en.pdf.