Continuing on from our last post, the following changes are happening or have happened to the PIC/S GMPs:
Annex 2 Biological Medicinal Products has progressed through the public consultation phase.
Annex 11 Computerised Systems has now been incorporated by the EU.
Annex 14 Medicinal Products Derived from Human Blood or Plasma, has been postponed because of possible conflicts with EU laws.
Lower on the priorities list is an update of Annex 15, Validation, to reflect ICHQ8, Q9 and Q10 documents. And possibly an update of Annex 17, Parametric Release.
A possible Part III to the GMP Guides!!
Site Master Files have also become a standard expectation of EU authorities.
It is proposed to create a new informational Part III of the EU GMP Guide for collection of the GMP related documents which are not themselves GMP guidelines and have no statutory force (i.e non- binding documents) but which complement the GMP guidelines and related regulatory procedures such as inspections.
Good Distribution Practice (GDP)
At the review stages, existing Community GDP guidance considering emerging legal proposals attempting to combat counterfeit medicinal products, considering WHO guidelines on this.
Proposals for GDP licensing and inspecting procedures were prepared. The work should be coordinated with PIC/SS working group on GDP.
The PIC/S Pipeline Part 4 of 4 (this blog)