Achieving More Effective and Efficient GMP Auditing - Pharmaceutical Technology

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Achieving More Effective and Efficient GMP Auditing
Adherence to GMP in API manufacturing is crucial in determining the safety of drug products. Due to the limitations of quality-control testing and repeatedly occurring major API adulterations, the regulations for supplier qualification have been globally tightened. As a consequence, authorities demand more vigilance of the pharmaceutical supply chain. API and other starting material manufacturers are facing an ever-increasing demand for on-site audits from their pharmaceutical customers.


Pharmaceutical Technology


References

1. M. Tawab, Pharm. Ind. 72 (2) 231-240 (2010).

2. M. Tawab, Pharm. Ind. 72 (3) 418-426 (2010).

3. EC Directive 2011/62/EU, Falsified Medicines Directive, amending Directive 2001/83/EC (Brussels, July, 2011).

4. EC, Draft Chapter 5, "Production," in Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Eudralex, Vol. 4 (Brussels, 2010), http://ec.europa.eu/health/files/gmp/chapter5_pc11-2010.pdf, accessed Jan. 11, 2013.

5. EMA, "Q&A: Good Manufacturing Practice," http://www.ema.europa.eu/Inspections/GMPfaq.html, accessed Jan. 8, 2013.

6. EMA, EMA/INS/GMP/459921/2010 Rev 13, "Procedure for Dealing with Serious GMP Non-compliance or Voiding/Suspension of CEPS Thus Requiring Co-ordinated Administrative Action," in: Compilation of Community Procedures on Inspections and Exchange of Information (London, 2010).

7. MHRA, "Good Manufacturing Practice: Common deficiencies," http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodManufacturingPractice/FAQ/Commondeficiencies/, accessed Jan. 8, 2013.

8. C. Hösch, Pharm. Ind. 71 (6) 1035-1038 (2009).

9. C. Hösch, Pharm. Ind. 71 (7) 1229-1233 (2009).

10. S. Kettelhoit, Pharm. Ind. 72 (2) 242-247 (2010).

11. FDA, Program 7356.002F, Chapter 56 "Drug Quality Assurance Program," in FDA Compliance Program Guidance Manual (Silver Spring, MD, Sept. 2003).

12. PIC/S PI 030-1, Aide-Memoire Inspection of Active Pharmaceutical Ingredients (Geneva, 2009).

13. S. Kettelhoit and R. Voeller, Pharm. Ind. 74 (6) 902-912 (2012).

14. EMA, EMA/INS/GMP/459921/2010 Rev 13, "A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers," in Compilation of Community Procedures on Inspections and Exchange of Information (London, 2010).

15. EMA, EMA/INS/GMP/459921/2010 Rev 13, "Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials," in Compilation of Community Procedures on Inspections and Exchange of Information (London, 2010).

16. QP Association, "Checklist Auditor Qualification and Performance," http://www.gmp-compliance.org/daten/training/QPA_Checklist.pdf, accessed Jan. 8, 2013.

17. H. Champion, "Shared Supplier Audits—A new day for supply chain quality," http://www.contractpharma.com/issues/2012-09/view_features/shared-supplier-audits-275514, accessed Jan. 8, 2013.

18. Rx-360, Rx-360 Audit Standards for Active Pharmaceutical Ingredients and API Intermediates, v. 1.0 (Washington, DC, Aug. 2010).

19. D. Ewalt, et al., Pharm. Tech. 36 (10) 124-127 (2012).

20. API Compliance Institute, "What Is the APIC Audit Programme?" http://www.api-compliance.org/mse_APICOMPLIANCE_Registration.html, accessed Jan. 8, 2013.

21. EXCiPACT, Certification Standards for Pharmaceutical Suppliers: Good Manufacturing Practices, Good Distribution Practices (Brussels, Jan. 2012).


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