Notice to stakeholders – Draft guidance document for consultation: Guide to Good Manufacturing Practice for Medicinal Products Annex 1: Manufacturing of sterile medicinal products

Health Canada was pleased to release the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products Annex 1 Manufacture of Sterile Medicinal Products for a 5-month consultation period, from February 20, 2020 to July 20, 2020. 

This Annex was updated after considering over 6200 stakeholder comments received from the December 20, 2017 to March 20, 2018 consultation. This second consultation was intended to focus on limited sections that were subject to changes of significance — see below.  

Once finalized, Health Canada's intention is to adopt this Annex within Health Canada's GUI-0119: Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs.  It will be published in both official languages and support compliance with good manufacturing practices and drug establishment licence requirements prescribed in Part C, Division 1A and Division 2 of the Food and Drug Regulations. 

This consultation document was only available in English since this is the operating language of PIC/S. It was formatted with prescribed line and page numbers to support a joint international consultation within PIC/S, the World Health Organization (WHO) and the European Commission.  Health Canada is a PIC/S Participating Authority that is engaged in the joint international consultation and the drafting of the revisions to the Annex.

We encouraged you to review the document and to send us your comments. Health Canada will assess all stakeholder comments received and consider them in developing a Canadian position prior to adopting this Annex. Comments that were received will be evaluated and complied by Health Canada before being transmitted to the joint international working group for consideration in drafting the final version of the document.

Background

The consultation document was prepared in cooperation with the European Medicines Agency (EMA), WHO, and PIC/S in order to maintain global alignment of standards, all the while assuring the highest quality document possible. The document was subject to parallel public consultation by the European Commission, WHO and PIC/S.

As detailed in the European Commission consultation notice, stakeholders were encouraged to submit comments through one of the associations listed below. These associations representing relevant stakeholders accepted to take part in this second consultation. They agreed to receive comments from their members, to compile them and submit them to the joint international working group through the European Commission.

• A3P (Association for Products Propres and Parentals)
• AESGP (Association of the European Self-Medication Industry)
• AnimalhealthEurope
• APIC (Active Pharmaceutical Ingredient Committee)
• EAEPC (European Association of Euro-Pharmaceutical Companies)
• ECA (European Compliance Academy)
• EFPIA (European Federation of Pharmaceutical Industries and Associations)
• EGGVP (European Group for Generic Veterinary Products)
• EIPG (European Industrial Pharmacist Group)
• GIRP (European Healthcare Distribution Association)
• ISPE (International Society for Pharmaceutical Engineering)
• Medicines for Europe
• PDA (Parenteral Drug Association)
• PHSS (Pharmaceutical & Healthcare Sciences Society)
• EQPA (European Qualified Person Association)
• Vaccines Europe

The scope of this consultation was intended to be focused on key changes that have occurred since the previous version.  Key changes from the earlier PIC/S Annex included revisions due to stakeholder feedback on:

• qualification & requalification of cleanroom (paragraphs 4.25 to 4.35)
• handling of water systems (paragraphs from 6.7 to 6.15)
• integrity testing of large volume parenteral container (paragraph 8.21)
• handling of sterilizing filter including pre-use post sterilization integrity testing (PUPSIT) (paragraphs 8.88, 8.95, and 8.96)
• handling of lyophiliser (paragraph from 8.110 to 8.113)
• sterility testing (paragraphs from 10.6 to 10.7)

Other key changes introduced as a result of subsequent review included:

• definition and handling of barriers systems including disinfection/decontamination (paragraphs 4.18 to 4.24)
• handling of gas filters (paragraphs 6.18 to 6.20 and 8.89 to 8.90)
• personnel qualification & gowning (paragraphs 7.5 to 7.6 and 7.14 to 7.16)
• aseptic production (paragraphs 8.11 to 8.19)
• moist heat sterilisation (paragraphs 8.54 to 8.65)
• personnel monitoring (paragraphs 9.32 to 9.33)
• aseptic process simulation (paragraphs 9.34, 9.40, and 9.47)
• quality control (paragraph 10.1)