The Chapter 4 ("Documentation") of the EU Guideline to GMP has been released for public consultation. The deadline for comments is 31 October 2008. Comments should be sent to entr_gmp@ec.europa.eu or GMP@emea.europa.eu.

Chapter 4 has been mainly updated as a consequence of the new Annex 11 on computerised systems. However, other general changes and further explanations were included (for example with respect to style, language and revision histories). It does also distinguish between instructions and records. The definitions listed under 4.1 are amended accordingly.

The revised Chapter 4 calls for a Quality Manual System (QMS), where documents and media should be fully defined. As part of the QMS, a Documentation Management System (DMS) should be in place to ensure accuracy, integrity and proper control of all kind of documents. Furthermore, the new chapter includes expectations 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 by this chapter.

The role of the Qualified Person is also explained in more detail. All records should be available to the QP for review when requested. Appropriate records should routinely be provided to the QP for batch certification. However there is no obligation implemented that the QP is obliged to review and approve (sign) all GMP-relevant documents.

You can find the document here: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_04/
gmp_chap_4_consult_200804.pdf

To take a look at the comparison of the current chapter 4 and the new draft and to see the new and revised parts, please go here.


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