March 1st, 2014, will see the newest revision of the PIC/S GMP Guide (PE 009-11) come into effect, replacing the previous version PE 009-10 that has been current since January 2013.
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
The changes include the addition of a new section 2.2 titled “Quality Risk Management” (QRM) to Part II of the Guide. Part II provides guidance on the manufacture of Active Pharmaceutical Ingredients (API’s) and is based on ICH Q7. The section will not be new to some, as the text contains the same commentary on QRM from Part I Chapter 1 of the current Guide, bring both parts into alignment. Both QRM sections continue to refer to Annex 20 “Quality Risk Management” (based on ICH Q9) for further processes and application of QRM.
Changes to Annex 2
Annex 2 titled “Manufacture of biological medicinal products for human use” has undergone a major revision with the annex now divided into two main parts. Part A will contain supplementary guidance on the manufacture of biological medicinal substances and products, from control over seed lots and cell banks or starting material through to finishing activities and testing. Part B will contain further guidance on selected types of biological medicinal substances and products. The revision now contains a useful table (Table 1) that illustrates the manufacturing activities with the scope of Annex 2.
Changes to Annex 14
Also revised is Annex 14 “Manufacture of products derived from human blood or human plasma”. The Annex has been fully restructured and doubled in size, and now contains new chapters titled “Manufacturing” and “Release of intermediate and finished samples”.
PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
Version 4 of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-4) will also come into effect on March 1st, replacing the previous version 3 that has been current since October 2008. The new version contains a new annex (Annex 3) detailing good practices for the preparation of radiopharmaceuticals in healthcare establishments. The new annex contains sections on Personnel, Premises & Equipment, Documentation, Production, Quality Control and Monitoring.
The new revisions of all of the above documents are currently available for download on the News section of the PIC/S website at https://picscheme.org/.