Assessing and Managing Risks in a GMP Environment - Investing time and resources into conducting a risk assessment on a process or product can have a variety of benefits. Save your firm from

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Assessing and Managing Risks in a GMP Environment
Investing time and resources into conducting a risk assessment on a process or product can have a variety of benefits. Save your firm from regulatory headaches by making risk management part of its culture.


BioPharm International



Important concepts and terms
Risk monitoring and reevaluation are an important part of a risk management program, ensuring that the identified risks have been controlled and mitigated as planned. Monitoring should be instituted to see if additional, previously unpredicted risks appear. This can be done with information generated from incident investigations or product complaints. If an incident does occur, it is useful to examine the earlier risk assessment to discover if it was considered.

James L. Vesper, MPH is president ofLearningPlus, 1140 Highland Ave., Rochester, NY14620, 585.442.0170, fax 585.442.0177,

REFERENCES 1. A survey of risk: be prepared. The Economist. 2004 Jan. 22;12-14.

2. FDA: Pharmaceutical cGMPs in the 21st century: A risk-based approach. 2002 August 21. Available at http://www.fda.gov/cder/gmp/.

3. FDA. Quality system regulation: Design validation. Code of Federal Regulations 21CFR Part 820.30(g). 2004 April 1.

4. FDA. 21 Hazard analysis and hazard analysis critical control point (HACCP) plan (for seafood). Code of Federal Regulations 21CFR Part 123.6. 2004 April 1.

5. FDA. Hazard analysis and critical control point systems (for juices). Code of Federal Regulations 21CFR Part 120. 2004 April 1.

6. FDA. Thermally processed low-acid foods packaged in hermetically sealed containers. Code of Federal Regulations 21CFR Part 113. 2004 April 1.

7. FDA: Guidance for industry: Q7A good manufacturing practice for active pharmaceutical ingredients. 2001 August. Available at http://www.fda.gov/cder/guidance/4286fnl.pdf.

8. US Occupational Health and Safety Administration (OSHA). Process safety management of highly hazardous chemicals. Code of Federal Regulations 29CFR Part 1910.119(e). 1993.

9. US Environmental Protection Agency (EPA). Hazard Assessment. Code of Federal Regulations 40CFR Part 68 Subpart B. 1996 June 20.

10. Health Canada. Quality management in good manufacturing practices guidelines. 2002 Edition, Version 2. Ottawa. 2003 Jan. 20.

11. ICH6. ICH meeting report. 2003 Nov. 15. Osaka, Japan. Available at http://www.ich.org/.

12. ISPE GAMP Forum. The good automated manufacturing practice (GAMP) guide for validation of automated systems in pharmaceutical manufacture, 4th Edition. Tampa (FL): ISPE; 2001.

13. ISPE. Guideline for risk assessment. GAMP4 Appendix M3. Tampa (FL): ISPE; 2001.

14. International Standards Organization. Medical devices — Application of risk management to medical devices. ISO 14971:2000. Geneva Switzerland: ISO; 2000.

15. FDA. Guidance for industry: Immediate release solid and oral dosage forms scale-up and post approval changes. FDA/CDER. Bethesda MD. 1995 November. Available at http://www.fda.gov/cder/guidance/cmc5.pdf.


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