In March 2008, the PIC/S issued the Guide to Good Practices for the
Preparation of Medicinal Products in Healthcare Establishments (PE 010-1),
which came into force on 1 April 2008. This document replaces the former draft
guideline with the deviating title "Guide to Good Practices for Preparation of
Medicinal Products in Pharmacies".
At the same time, a corrigendum to the new guide was published, since Annex 1,
Paragraph 54i erroneously mentions sterile filters with a maximum pore width of
22 µm instead of the correct 0.22 µm. In the meantime, this correction was
included in the official version, which now bears the version number PE 010-02.
The contents of the new guide are directed at healthcare establishments, like
pharmacies or hospitals, and describe the basic requirements on the manufacture
of medicinal products and preparations for the direct supply to patients. The
structure of the document corresponds to that of the guide PIC/S PE 009 covering
the industrial manufacture of medicinal products.
Two annexes complement the document: Annex 1 deals with the requirements on the
sterile manufacture of medicinal products. This already includes the limit for
particles of 5.0 µm in size laid down in the new Annex 1 to the EC GMP Guide,
which will come into operation in March 2009. Annex 2 defines the requirements
on the manufacture of non-sterile creams and ointments.
Link to the new guide:
http://www.picscheme.org/publis/guides/PE 010 2 GPP Guide.pdf
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)