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13 May 2008
Revised Chapter 4 of the EU Guideline to GMP gives explanations about the
QP's responsibilities regarding documentation review and approval
The Chapter 4 ("Documentation") of the EU Guideline to GM 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.
In the revised Chapter, the role of the Qualified Person is 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.
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 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.
You can find the document here:
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_04/gmp_chap_4_consult_200804.pdf
Author:
Wolfgang Schmitt
On behalf of the European QP Association
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