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 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|
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