Revised Chapter 4 of the EU Guideline to GMP Released for Public Consultation

GMP News
14 May 2008

Revised Chapter 4 of the EU Guideline to GMP Releasedfor Public Consultation

The Chapter 4 ("Documentation") of the EU Guideline to GMP has been released forpublic consultation. The deadline for comments is 31 October 2008. Commentsshould be sent to entr_gmp@ec.europa.euor

Chapter 4 has been mainly updated as a consequence of the new Annex 11 oncomputerised systems. However, other general changes and further explanationswere included (for example with respect to style, language and revisionhistories). It does also distinguish between instructions and records. Thedefinitions listed under 4.1 are amended accordingly.

The revised Chapter 4 calls for a Quality Manual System (QMS), where documentsand media should be fully defined. As part of the QMS, a DocumentationManagement System (DMS) should be in place to ensure accuracy, integrity andproper control of all kind of documents. Furthermore, the new chapter includesexpectations regarding electronic documents and refers to the new Annex 11.

The requirements apply to a large variety of documents and associated records;starting with the collection of data up to final reports. Paper based documents,hybrid forms and various media types and electronic systems are all covered bythis chapter.

The role of the Qualified Person is also explained in more detail. All recordsshould be available to the QP for review when requested. Appropriate recordsshould routinely be provided to the QP for batch certification. However there isno obligation implemented that the QP is obliged to review and approve (sign)all GMP-relevant documents.

You can find the document here:

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)


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