Past, Present and Future PIC/S GMP Part 1 of 4

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Past, Present and Future PIC/S GMP Part 1 of 4

In January of 2011, the Health Products Regulation Group (HPRG) Health Sciences Authority (HSA) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers.

One session, conducted by the HSA’s Boon Meow Hoe, traced through the history, current applicability and future trends of PIC/S GMP.

PIC/S History

PIC/S has been at the forefront of Good Manufacturing Practice (GMP) standards and guidance documents for some years. As one of the pre-eminent regulatory authorities in the world, PIC/S updates are keenly followed and investigated by pharmaceutical manufacturers and all pharmacovigilance partners.

We’ve already covered why PIC/S compliance is important in a previous blog. In this blog,  a review of recent PIC/S activity is listed in the table below, showing the progression of GMPs and guidance documents in recent times.

The original PIC/S GMP Guide of 1972 is a derivative of the WHO GMP Guide. The EU adopted its unique GMP Guide in 1989. Equivalence with the PIC/S GMP Guide was realised and since then the EU and PIC/S have shared GMP updates and revisions. Consequently, the EU and PIC/S GMP Guides are very similar.

Initially, the PIC/S GMP Guide consisted of what is referred to now as ‘Part I’. In 2001 PIC/S utilised the ICH Q7A document as a separate guide for APIs, PE 007. Only in 2006 was the GMP Guide for API incorporated as Part II of the PIC/S GMP Guide.

DateVersion NumberReasons for revision
21 December 2000PH 1/97 (Rev.)
  • Revision of Annex 14
  • Renumbering of all annexes
  • Change in the editor’s address and insertion of copyright statement
  • Inclusion of revision history
10 August 2001PH 1/97 (Rev.2)
  • Amendment of para. 42 of Annex 1
  • Revision of Annex 6
  • New Annex 15
  • New Annex 17
  • Amendment to the glossary
15 January 2002PH 1/97 (Rev.3)
  • New Annex 4
  • New Annex 5
  • Reference to Annex 18 of EC GMP Guide
1 September 2003PE 009-1
  • Amendment of Annex 1 (mainly section 3)
1 July 2004PE 009-2
  • Revision of Annex 13
  • Change in the Editor’s co-ordinates
1 January 2006PE 009-3
  • Revision of Chapter 1 (Add PQR)
1 June 2006PE 009-4
  • Revision of Chapter 6 (Add On-Going Stability Programme)
1 August 2006PE 009-5
  • Corrections to revision of Chapter 6
  • Revision of Chapter 8 (add requirements on counterfeit products)
5 April 2007PE 009-6
  • Reorganisation of the PIC/S GMP Guide in Part I, Part II and Annexes (EU level came into operation in Oct 2005)
  • Incorporation of PE 007 (APIs guide) as Part II
  • New Annex 19 (EU level came into operation on 1 Jun 2006)
  • Revision of the Introduction
  • Changes in the Editor’s co-ordinates
1 September 2007PE 009-7
  • Revision of General Introduction (“History”) and Introduction to Part II
  • Deletion of footnotes in Chapter 6 (Part 1) and Annex 13
15 January 2009PE 009-8
  • Revision of Chapter 1 (Part I) (Add QRM)
  • Revision of Annex 1
  • New Annex 20 (QRM) (EU level came into operation in Mar 2006)
1 September 2009PE 009-9
  • Revision of Annex 3 – Manufacture of Radiopharmaceuticals (EU level came into operation on 1 Mar 2009)

Related blogs:

Past, Present and Future PIC/S GMP Part 1 of 4 (this blog)

Current PIC/S GMP Guides – Part 2 of 4

The PIC/S GMP Pipeline Part 3 of 4

The PIC/S Pipeline Part 4 of 4

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