|
On 30 August, the Pharmaceutical Inspection Cooperation Scheme (PIC/S)
adapted the PIC/S GMP Guide to the structure of the EC GMP Guide. Through this
measure, there are only few differences between the two documents left.
Like the EC GMP Guide, the PIC/S Guide is now divided into a
Part I concerning GMP for medicinal products and a Part II regarding GMP for
active pharmaceutical ingredients. Thus, PIC/S also placed the former Annex 18
Guide "GMP for APIs" as an equivalent document next to Part I for medicinal
products. Therefore, in addition to the requirements laid down in Part II
(identical to ICH Q7), all annexes are now relevant for the manufacture of active
pharmaceutical ingredients as well. Here, PIC/S will have to modify the annexes,
like the EU will do. This is important e. g. with regard to Annex 1
"Sterile Manufacture" because the Annexes have been written with a
focus on medicinal products, but not on APIs. Against the background of the re-structuring, a
revision of the Annexes is inevitable.
With the revision, the new requirements on the Product Quality
Review (PQR) and on-going stability have been integrated into the PIC/S Guide,
too.
However, there are also some differences between the PIC/S
Guide and the new EC GMP Guide:
-
The PIC/S does not know the function of the Qualified
Person as defined by EU legislation. Therefore, the Guide calls this
function "Authorised Person". For this reason, Annex 16 on "Certification by
a Qualified Person and Batch Release" does not exist in the PIC/S Guide.
-
All references to EC Directives in the GMP Guide were
deleted.
-
Since not all PIC/S members are in the European
Pharmacopoeia, the PIC/S Guide does not only refer to the EP, but also to
other relevant pharmacopoeias (e. g. JP or USP).
The choice of title is a bit unfortunate for Part II of the
PIC/S GMP Guide. In contrast to the EC GMP Guide, it does not have the subtitle
"Basic Requirements for Active Substances used as Starting Materials".
In the following you will find the links to the new guide:
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (PART I)
http://www.picscheme.org/publis/guides/PE 009-7 GMP Guide (Part I Basic
Requirements for Medicinal Products).pdf
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART II
http://www.picscheme.org/publis/guides/PE 009-7 GMP Guide (Part II Basic
Requirements for APIs).pdf
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (ANNEXES)
http://www.picscheme.org/publis/guides/PE 009-7 GMP Guide (xAnnexes).pdf
|
