Tag Archives: PIC

More than a Generation of Husbanding Scarce Professional Resources

The PHARMACEUTICAL INSPECTION CONVENTION (PIC) was formed in 1970 by the 10 countries that at the time comprised the European Free Trade Association (EFTA). Some of those countries have since left the PIC and others have joined.

The initial objectives included harmonisation of Good Manufacturing Requirements (GMP) and Mutual Recognition of Inspections carried out by Inspectors from PIC countries. With the explosive worldwide growth of pharmaceutical manufacturing and related activities it was recognised that were not enough experienced Inspectors to cope with the expanding workload of inspections and associated activities.

Legal and other reasons prevented certain other countries from joining the PIC and in 1995 the PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S) was formed. Essentially and, one might say, cleverly, PIC and PIC/S operate jointly thereby allowing a larger group of countries to task inspectors with participating in inspections. The findings are shared as and when needed and are mutually recognised by all member countries (currently 51 as at 15 May 2018).

A PIC/S Committee and PIC/S Executive Bureau meeting took place in Geneva, Switzerland on 15-18 April 2018 and minutes of the meeting were published on 9 May 2018.

Headlines are:

  • NEW PIC/S GUIDANCE ON GMP INSPECTION RELIANCE BASED ON DRAFT BY ICMRA WITH AIM TO MAXIMISE INSPECTION RESOURCES FOR GMP COMPLIANCE OF OVERSEAS FACILITIES

  • REVISION OF PIC/S GMP GUIDE (PE 009). CHAPTERS 3, 5 AND 8 OF THE PIC/S GMP GUIDE HAVE BEEN REVISED AND WILL ENTER INTO FORCE ON 1 JULY 2018; ALONG WITH ADOPTION OF TRANSPOSITION FOR PIC/S PURPOSES OF EU GUIDANCES ON GMP EXICIPENT RISK ASSESSMENT, EXPOSURE LIMITS AND GDP FOR API

  • NEW PIC/S WORKING GROUP ESTABLISHED WITH W.H.O. TO REVISE ANNEX 2 ON BIOLOGICALS AND ATMP

  • FOCUSED STAKEHOLDER CONSULTATION FOR DRAFT PIC/S GUIDANCE ON DATA INTEGRITY

  • NEW PIC/S AIDE-MEMOIRE ON CROSS-CONTAMINATION IN SHARED FACILITIES

  • NEW PIC/S PRE-ACCESSION APPLICATION RECEIVED FROM PAKISTAN / DRAP

  • NEW PIC/S WORKING GROUPS TO BE ESTABLISHED ON WHISTLE-BLOWERS/CONFIDENTIAL INFORMANTS; QUALITY DEFECTS PROCEDURES; AS WELL AS PIC/S ASSESSMENT AND RE-ASSESSMENT PROCEDURES

  • PIC/S 2018 SEMINAR TO BE HOSTED BY US FDA IN CHICAGO AND OTHER NEWS IN THE FIELD OF TRAINING FOR GM(D)P INSPECTORS

ICMRA = International Coalition of Medicines Regulatory Authorities

GMP = Good Manufacturing Practices

API = Active Pharmaceutical Ingredient

W.H.O. = World Health Organisation

ATMP = Advanced Therapy Medicinal Products

DRAP = Drug Regulatory Authority of Pakistan

GM(D)P = Good Manufacturing (Distribution) Practices

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