PIC/S update to PE009 – version 14 on its way

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PIC/S update to PE009 – version 14 on its way

In a recent press release, the PIC/S Committee recently announced the revision of the PIC/S GMP Guide (PE 009) to PIC/S version 14, with updates to:

  • Chapter 3 – Premises and Equipment
  • Chapter 5 – Production
  • Chapter 8 – Complaints and Product Recall

According to PIC/S, these chapters have been revised based on the equivalent chapters of the EU GMP Guide (Eudralex, Volume 4), and now provide further expectations around the principles of Quality Risk Management.

Despite their recent fuss over the planned updates to Annex 1 – Manufacture of Sterile Medicinal Products (currently under consultation), it doesn’t appear that the revised Annex 1 will be a part of this version.

The revisions to the PIC/S Chapters 3 and 5 now include requirements to prevent cross-contamination – something which is was traditionally covered in the EU GMP Guide with far greater detail. The EU GMP Guide highlights different methods to prevent cross-contamination by outlining various technical measures (e.g. use of ‘closed systems’ for processing and material/product transfer between equipment and the use of single use disposable technologies), as well as organisational measures (e.g. cleaning verification after each product campaign and the design of cleaning processes so that the cleaning processes themselves do not present a cross-contamination risk). The EU GMP also provides a clearer expectation regarding the circumstances in which dedicated facilities are required (based on facility-specific risk assessments).

If looking at the EU GMP Guide provides an indication of what to expect, there will be significantly more detail now included in the PIC/S Guide; from heightened expectations on the handling and investigating of complaints and product recalls, to documenting more details in the decision making process, to more thorough root cause analysis, and the appropriate assignment of corrective and preventive actions. The PIC/S Committee has also indicated that Chapter 8 has been entirely revised, with additional expectations relating to the utilisation of Quality Risk Management principles in the investigation and assessment of quality defects when dealing with product recalls.

The revised GMP Guide (PE 009-14) will be published by PIC/S on 1 July, 2018, however it is up to each non-EU/EAA Participating Authority (i.e. Australia’s TGA, Health Canada, etc.) to transpose the revised chapters into their own GMP Guides.

With the Chapters 3 and 5 of the PIC/S Guide adding more expectations around the prevention of cross-contamination, it seems appropriate that the Aide-Memoire on Cross-Contamination in Shared Facilities (in draft since 2016), developed by the PIC/S Working Group on Controlling Cross-Contamination in Shared Facilities (CCISF) will be also be published 1 July 2018. While this is intended as a guidance document for GMP inspectors, Aide-Memoires can be useful tools for GMP manufacturers because they address what may be evaluated at a later state when ensuring GMP compliance. Again, it’s highlighted in this document that PIC/S promotes a risk-based approach in areas such as cross-contamination hazard assessment, and technical measures and organizational controls, as mentioned previously in the updates to Chapters 3 and 5.

If you would like to read more on similar topics, you might be interested in the following blogs:

Proposed Changes to EU GMP Annex 1 – Sterile Manufacture 

Potent Pharmaceutical Drugs – Containment Control Strategy

Quality Risk Assessment

If you are worried about the upcoming changes to PIC/S in regards to handling risk management, PharmOut also provides training on Quality Risk Management to help set your mind at ease.