PIC/S GMP Guide PE 009 and its 5 linked instruments

The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11. PIC/S co-drafts the current EU revisions.

The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation.

Health Canada guidance on computerized systems, adopted directly from Annex 11 of the PIC/S GMP Guide (PE 009-15), with some terms replaced by Canadian ones. Link only.

Japanese administrative notice from the health ministry (MHLW), hosted by PMDA, introducing the PIC/S GMP Guide as guidance for GMP at manufacturing sites. The English is a tentative translation. Link only.

PIC/S guidance giving inspectors recommendations and background on computerised systems, for training and for use during inspections. It supports the PIC/S GMP Guide and its Annex 11 and is written for all good practice inspectors in the regulated pharmaceutical sector. Link only.

PIC/S recommendations on qualification and validation, updating PI 006-3 of 2007. Link only.

• 23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17

• ~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011)
• 30 Jun 2011 Came into operation

• 10 Aug 2021 Published

• 1 Feb 2012 Administrative notice issued

• 1 Sep 2003 Entered into force
• 25 Sep 2007 Version PI 011-3 dated 25 Sep 2007

• 1 Oct 2026 Version PI 006-4 dated 1 Oct 2026