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Friday, December 30, 2016

Revision of PIC/S GMP Guide PE 009-13 GUIDE TO GOOD MANUFACTURING PRACTICE

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Geneva, 22 December 2016: the following Chapters of the PIC/S GMP Guide have been revised:
  • Chapter 1 on “Quality Management” (which has become “Pharmaceutical Quality Systems”); 
  • Chapter 2 on “Personnel”;
  • Chapter 6 on “Quality Control”; 
  • Chapter 7 on “Contract Manufacture and Analysis” (which has become “Outsources Activities”).
The revised Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. Chapters 1, 2 & 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated. A section on consultants has been added in Chapter 2. The scope of Chapter 7 has been expanded beyond the scope of “contract manufacture and analysis”. Both Chapters 1 and 7 have been renamed to reflect the changes. In Chapter 6, all sections have been reviewed and amended and a new section on “Technical transfer of testing methods” has been added.
The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). The revised GMP Guide (PE 009-13) will enter into force on 1st January 2017. All non-EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.
1.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
     Download Link
2.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
  PART II  Download Link
3.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS       
   ANNEXES
1.    Annex 1 (Manufacture of sterile medicinal products)
2.    Annex 2 (Manufacture of biological medicinal substances and products for human use)
3.    Annex 3 (Manufacture of radiopharmaceuticals)
4.    Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)
5.    Annex 5 (Manufacture of immunological veterinary medical products)
6.    Annex 6 (Manufacture of medicinal gases)
7.    Annex 7 (Manufacture of herbal medicinal products)
8.    Annex 8 (Sampling of starting and packaging materials)
9.    Annex 9 (Manufacture of liquids, creams and ointments)
10. Annex 10 (Manufacture of pressurised metered dose aerosol preparations for inhalation)
11. Annex 11 (Computerised systems)
12. Annex 12 (Use of ionising radiation in the manufacture of medicinal products)
13. Annex 13 (Manufacture of investigational medicinal products)
14. Annex 14 (Manufacture of medicinal products derived from human blood or plasma)
15. Annex 15 (Qualification and validation)
16. Annex 16 [Qualified person and batch release]*
17. Annex 17 (Parametric release)
18. Annex 18 [GMP Guide for active pharmaceutical ingredients]**
19. Annex 19 (Reference and retention samples)
20. Annex 20 (Quality risk management)***
·         Appendix I: Risk Management Methods and Tools Basic Risk Management Facilitation Methods
·         Appendix II: Potential Applications For Quality Risk Management


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