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GDPs, APIs, and non-European GMPs on PIC/S Radar Screen as Membership Expands

Dec 29th, 2011

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The Pharmaceutical Inspection Cooperation Scheme (PIC/S) is taking a close look at the developing global guidance on good distribution practice (GDP), including the new guidance that has been emerging from Europe and WHO, in assessing its expansion into the GDP arena. Also on PIC/S’ radar screen are active pharmaceutical ingredients (APIs) and the organization’s relationship to the GMPs of its expanding membership – in particular, those of FDA.

PIC/S’ focus to date has primarily been on GMPs for finished dosage forms, and the assessment of the equivalency of member processes has been based accordingly.

However, the need for increasing communication and cooperation between agencies to meet the challenges of regulating pharmaceutical quality in an increasingly complex global supply chain is a strong driver for participation in PIC/S and, in turn, for increasing its focus in the GDP and API arenas.

The organization has set up GDP and API “expert circles” and working groups to explore how best to extend PIC/S’ reach into these areas.

At the PIC/S meeting in Cape Town, South Africa in November, the organization’s steering committee directed the GDP expert circle to report back at PIC/S’ next meeting in Geneva in May with recommendations for fulfilling its mandate to advance PIC/S’ GMPs, inspectional guidance and training in its area.

The API expert circle is also actively working to advance its respective mandate, and held an “advanced training course” on APIs in mid-October in Singapore.

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Also see the following related stories:

PIC/S’ Voluntary, Non-Political Status Touted by Regulators Involved

Multifaceted Falsified Medicines Directive Cleaed in Europe;  Implementation Will Pose Challenges for Industry and Regulators

New EU Draft Guideline Clarifies, Broadens and Deepens Expectations for GDPs

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