Dr Rainer Gnibl, GMP Inspector, Local Government of Upper Bavaria
The topic documentation and - directly linked to it - the topic data integrity are not new. Since the EU GMP Guide came into force in 1992, there has been a own chapter about documentation. Also Annex 11 regarding computerised systems has been valid since then. Part II of the EU GMP Guide (GMP for APIs) also contains requirements regarding documentation and data integrity. With the revision of chapter 4 on documentation in 2011, a new sub-chapter about Good Documentation Practice was added. Annex 11 was also revised in 2011. Requirements for the qualification and validation documentation are mentioned in Annex 15 and in the FDA Guidance on Process Validation. The rules are in principle very simple: it is all about traceability.. In the last years, deficiencies, either accidental or deliberate have been occurring. What are the requirements in terms of data integrity in qualification and validation documentation, especially with the integration of external documents from suppliers and external services? Get first hand information from a GMP inspector.
Employees from companies, who are involved in qualification and process validation activities (heads of production, heads of validation group, developers, QM, etc.) are addressed. Also suppliers and service providers who deliver qualification and validation documentation or make entries in these documents are also addressed as well as consultants in this field.
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From an inspector´s view, the following issues will be addressed:
- What documentation is needed during qualification and validation?
- Protocol vs record vs report
- What areas are critical?
- Who is responsible for qualification and validation documentation?
- Basic requirements for a GMP compliant (?) documentation
- Good Documentation Practice
- GMP-compliant Data integrity – what is that?
- ALCOA Plus
- Implementation of suppliers – what is important?
- Electronic documentation from a supplier – how to handle and to archive in accordance with GMP
- Entries from service providers – the devil is in the detail
- Case studies from GMP inspections
- What is the inspector looking for? Oder eher What does the inspector pay attention to?