The PIC/S meeting in Kiev discussed and agreed on changes to PE009-9 to support the harmonisation of GMP guidance documents. PIC/S code of GMP PE-009-10 was issued by PIC/S on the 11th December, and whilst this goes some way in aligning our international GMPs and specifically the EMEA code of GMP, there are still significant differences.
The PIC/S GMP has continued to retain Part I and Part 11 and is not yet aligned with the 3 part structure of the EMEA GMPs. More significantly, the changes still to come into effect in the EU have not yet been adopted by PIC/S.
PIC/S GMP are still issued in 2 parts with 4 sections:
- PE 009-10 (Intro) PIC/S GMP guide (Introduction)
- PE 009-10 (Part I) PIC/S GMP guide (PART I: Basic requirements for medicinal products)
- PE 009-10 (Part II) PIC/S GMP guide (PART II: Basic requirements for active pharmaceutical ingredients)
- PE 009-10 (Annexes) PIC/S GMP guide (ANNEXES).
There are changes to the following sections:
- Part I Chapter 4, Documentation
- Annex 6, Manufacture of medicinal gases
- Annex 7, Manufacture of herbal medicinal products
- Annex 11, Computerised systems
- Annex 13, Manufacture of investigational medicinal products
1. Part I Chapter 4: Documentation
The changes to Chapter 4 have been required because of the increasing use of electronic signature and electronic records (ERES) within the GMP environment. Therefore the sections relating to the ‘generation and control of documentation’ and ‘retention of documents have been revised. This chapter should be assessed in conjunction with the new PIC/S Annex 11 which has also been revised.
Chapter 4 now provides better guidance on the classification of GMP documents, or document types, and defines document types like records and the implications of electronic forms.
2. Annex 6: Manufacture of medicinal gases
This update provides welcome clarification on starting materials referred to in Chapter 7 of Part II of the PIC/S GMPs. Most importantly, it now explicitly states that almost all the basic provisions in Part I and II are applicable to medical gases and that all the annexes should be considered for relevance. !
3. Annex 7: Manufacture of herbal medicinal products
The term “herbal medicinal product (and preparation)” is expanded to include “traditional herbal medicinal product/preparation”.
The application of Good Practices is better defined; this is always a difficult area with APIs and biological products and the code specifically points to Good Agricultural and Collection Practices (GACP) for starting materials of herbal origin. The WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal plants, and the EMEA Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin also offer useful guidance.
4. Annex 11: Computerised systems
Annex 11 has been well discussed and anticipated and this release aligns well with ICH, GAMP 5 and other current industry practice. The revised Annex provides a more defined approach to the requirements during the validation and operational phases for the lifecycle of a computer system.
Recently in PharmOut training sessions, we workshopped where industry are having the most difficulty. The top areas were:
- Quality Risk Management
- Maintaining an inventory of all computerised systems, GxP and non-GxP systems
- Maintaining the User Requirements Specifications (URS) which should be traceable throughout the life-cycle.
5. Annex 13, Manufacture of investigational medicinal products
This revision includes changes that have existed in the EMEA GMP for some time, particularly in clauses 36 and 37 relating to samples.
What is next in the pipeline?
In the Kiev meeting, the PIC/S Liaison Officer reported on the success of the “30 May 2012 agreement”, which related to a new procedure for the harmonisation of PIC/S and EU consultation procedures between PIC/S and the European Medicines Agency (EMA).
The first experiences with the implementation of this new procedure ensure better harmonisation between the EU and the PIC/S GMP Guides and related documents.
One of the main advantages of the new procedure is it ensures the earlier involvement of PIC/S non-EU countries in the EU revisions, as well as helping the EU use resources from non-EU countries (when needed). The planned revisions of Annex 15 on Qualification and Validation and Annex 17 on Parametric Release, which are subject to the new procedure, will be good examples of this new process, where Canada / HPFBI and USA / US FDA will take part in the drafting group for Annex 15 and Australia / TGA, Canada / HPFBI and USA / US FDA for Annex 17.
There are several changes in the EU GMP, with imminent implementation dates which could / should have been included in the current version on the PIC/S GMP, these are:
- Chapter 1, Pharmaceutical Quality System – due for implementation in the EU on the 31st January 2013
- Chapter 7, Outsourced activities – due for implementation in the EU on the 31st January 2013
- Annex 2, Manufacture of Biological active substances and Medicinal Products for Human Use – due for implementation in the EU on the 31st January 2013
Next year PharmOut staff will be presenting at a series of “evening updates” over dinner and drinks, if you are interested, why not click the PharmOut LinkedIn button to follow PharmOut and be advised of these events.
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