The earlier version of the document, published in 2007, made no mention of ‘distribution’. Now, following a meeting in November, Pharmaceutical Inspection Co-operation Scheme (PIC/S) includes ‘distribution’ alongside ‘manufacturing’ as a core area of its focus.
“[PIC/S will] continue common efforts for the development, harmonisation and maintenance of good manufacturing and distribution practice (GMDP)”, the organisation said. The switch from ‘GMP’ to ‘GMDP’ means PIC/S will include distribution in its training, harmonisation and cooperation efforts.
Addition of distribution activities to PIC/S follows a period of supply chain turbulence. Since PIC/S published the earlier version of its documentation cases of heparin contamination and growing awareness of counterfeiting have shaken confidence in fragmented global supply chains.
When the revision was discussed in June PIC/S said the “largely supported” change would address the “growing number of serious problems encountered during the inspection of the supply chain”.
In July the European Commission published draft GDP guidelines, which may form the basis for PIC/S’ GDP guide, and other regulators are also working to secure supply chains. PIC/S will promote global harmonisation of these efforts to save industry from a fragmented regulatory environment.
Confidential data
Addition of wording about confidentiality is the other big change. The ‘Sharing of information’ part of the document now applies to all classified data and PIC/S highlights the importance of respecting confidentiality.
“Participating Authorities herewith undertake to respect the confidentiality of information shared under this Scheme. They also undertake to avoid any potential or real conflict of interests with activities and issues under discussion at PIC/S”, the organisation said.
When the revision was discussed in June PIC/S said the step would “reinforce the confidentiality of information exchanged by Participating Authorities” and “avoid conflict of interests”.