PIC/S Guide: GMP for Healthcare establishments

PIC/S GMP Guide PE-010-1 for healthcare establishments: Establishments supplying medicinal products to their own patients in line with national legislation, like pharmacies or hospitals.

Whereas PIC/S Guide PE 009 applies to industrial manufacture of distributed medicinal products, the basic requirements presented in this Guide apply to the preparation of medicinal products normally performed by healthcare establishments for direct supply to patients. The PIC/S Guide PE-010-1 is divided into 9 main chapters, thus following the structure from the GMP Guide for industry (PIC/S document PE 009).

The main text is complemented with Annexes supplementing the main part of this Guide and specifying the general rules described in there for the preparation of specific types of medicinal products, such as sterile products (Annex 1), and non-sterile liquids, creams and ointments (Annex 2).

Into force since 1 April 2008: PIC/S GMP Guide PE-010-1 for healthcare establishments: http://www.picscheme.org/publis/guides/PE%20010%202%20GPP%20Guide.pdf