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.
| Date | Version Number | Reasons for revision |
|---|---|---|
| 21 December 2000 | PH 1/97 (Rev.) |
|
| 10 August 2001 | PH 1/97 (Rev.2) |
|
| 15 January 2002 | PH 1/97 (Rev.3) |
|
| 1 September 2003 | PE 009-1 |
|
| 1 July 2004 | PE 009-2 |
|
| 1 January 2006 | PE 009-3 |
|
| 1 June 2006 | PE 009-4 |
|
| 1 August 2006 | PE 009-5 |
|
| 5 April 2007 | PE 009-6 |
|
| 1 September 2007 | PE 009-7 |
|
| 15 January 2009 | PE 009-8 |
|
| 1 September 2009 | PE 009-9 |
|
Related blogs:
Past, Present and Future PIC/S GMP Part 1 of 4 (this blog)
Current PIC/S GMP Guides – Part 2 of 4