In January of 2011, the Health Products Regulation Group (HPRG) of Singapore’s Health Sciences Authority (HSA ) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers.
One session, conducted by the HSA’s Boon Meow Hoe traced the history, current applicability and future trends of PIC/S GMP. Below is a summary of his presentation.
The PIC/S Pipeline
To ensure Guides to GMP reflect advances in technology and maintain their effectiveness, bodies such as the PIC/S and ICH continue to update and include the latest thinking and strategies relevant to GMP.
For the first time, the PIC/S has beaten the EU ‘to the punch’ by adopting the revised “Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file” PE008-4, on January 1, 2011. The EU is yet to adopt this explanatory note.
Also on the 1st of January, 2011, the PIC/S adopted a revision to the “Recommendation on the Validation of Aseptic Processes document, PI007-6. The Malaysian /Kuala Lumpur agency has adopted this document, with changes to section 5.2, regarding low selectivity and growth promotion tests.
A general update and revision of Annex 6 Manufacture of Medicinal Gases has been adopted by the EU, and looks likely to be adopted by PIC/S at the upcoming Committee of Officials Meeting in May, 2011.
The same applies for Annex 13 Manufacture of Investigational Medicinal Products.
For the Herbal medicinal manufacturers, a revision of Annex 7 Manufacture of Herbal Medicinal Products has been effective in the EU since September 1, 2009 and is likely to be considered by PIC/S.
Active substances used as starting materials for the manufacture of herbal medicinals have been included in the revised Annex 7 and Good Agricultural and Collection Practice (GACP) was introduced.
Revision of Part I, Chapter 1
A revision to Chapter 1, Quality Management, is likely to impact many in the GMP world.
Harmonisation with ICHQ10 Pharmaceutical Quality System (ICHQ10) is the main driver behind the update. Those familiar with ISO Management Standards, such as ISO 9001 Quality management systems – Requirements and ISO13485 Medical devices – Quality management systems – Requirements for regulatory purposes, will recognise themes such as achieving;
- Product realisation and
- Facilitation of continual improvement.
Within the Quality Manual, emphasis on the Quality policy and Management responsibilities sections is anticipated.
CAPA systems will be subject to review and the Global Harmonisation Taskforce (GHTF) has also been busy updating CAPA guidance for Medical Device industries, titled Quality Management System – Medical Devices – Guidance on corrective action and preventive action and related QMS processes (CAPA). The GHTF are referring to terms such as escalation and classification of CAPAs and alert and alarm limits.
Process performance and product quality monitoring are also under review and statistical tools may form part of the update. Process knowledge, critical quality attributes and critical process parameters are also under consideration.
Management review of the QMS is also being considered, such as inputs and outputs of the review process and formalisation.
Revision of Part I, Chapter 2 Personnel
Again, harmonisation with ICH Q10 is a driver. Adequate resourcing for maintaining the QMS and continuous improvement effectiveness will be considered. Leadership, consultants and changes in product ownership may be addressed.
Revision of Part I, Chapter 3 Premises & Equipment
Toxicological tools and QRM may feature here.
Revision of Part I, Chapter 4 Documentation
References to Site Master File and parallels with Annex 11 Computerised Systems are under consideration.
Revision of Part I, Chapter 5 Production
Qualification of suppliers and testing of starting materials will depend on new EU laws to protect against counterfeits.
Revision of Part I, Chapter 6 Quality Control
Analytical method transfer is at the very early stages (concept paper) of review
Revision of Part I, Chapter 7 Contract Manufacture and Analysis
Contract Manufacture and Analysis looks in line for a name change – Outsourced Activities will widen the scope of this chapter and maintain the alignment with ICH Q10 guidance.
Revision of Part I, Chapter 8 Complaints and Product Recall
A concept paper is under development and this is likely to see QRM implemented specifically for complaints and product recall requirements. Also, reporting on where product shortages occur due to manufacturing issues.
And just to break with tradition, Chapter 9 looks unlikely to be revised!
The PIC/S GMP Pipeline Part 3 of 4 (this blog)