GMP-compliant documentation is an important element!
The GMP requirements for documentation can be found in Chapter 4 of the EU GMP-Guideline. The documentation consists of standard and recording documents and can be paper-based or electronic. What rules and guidelines are there and how can they be implemented in practice?
- What is part of the GMP documentation?
- How can documentation be done?
- Which documents are GMP-relevant?
- Purpose of the documentation
- What is Compliance?
- Specification documents
- Recording documents
- The meaning of the signature
- What are raw data?
- GMP-compliant documentation systems