Auditing Safety-Related Processes and Procedures: Lessons Learned for Global Compliance and Quality

Abstract

Given the major public health importance of medical product safety, it has never been more critical for companies to ensure that their processes and procedures for performing premarketing clinical safety and postmarketing vigilance are in compliance with regulatory requirements and foster the ongoing accumulation of high-quality data. The evolving global environment for medical product safety necessitates that companies look beyond strictly local (ie, national) regulatory requirements to meet the demands of the new international paradigm. Utilizing a proactive approach that entails ongoing auditing of safety-related processes and procedures for effectiveness and compliance with appropriate remediation, medical product safety departments can be better prepared for regulatory agency inspections while maximizing their contribution to company vigilance/risk management efforts.

Examining results of safety-related audits executed internationally provides insight into deficiencies that are common across companies and medical product categories, while offering lessons learned of global applicability.

Keywords

Standard operating procedures (SOPs)Auditing Safety Pharmacovigilance Compliance

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References

Department of Health and Human Services, US Food and Drug Administration. Safety reporting requirements for human drug and biological products [Proposed Rule]. Federal Register 2003: 68(50):12406–12497. Available at: www.fda.gov/OHRMS/DOCKETS/98fr/03–5204.pdf. Accessed February 17, 2005.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Topic E6: Guideline for good clinical practice: ICH harmonised tripartite guideline. Available at: www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB. Accessed February 18, 2005.

US Food and Drug Administration, Center for Drug Evaluation and Research. Chapter 53—postmarketing surveillance and epidemiology: human drugs: enforcement of the postmarketing adverse drug experience reporting regulations. September 30, 1999. Available at: www.fda.gov/cder/aers/chapter53.htm. Accessed February 17, 2005.

Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed February 17, 2005, and March 1, 2005.

European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products. Position paper on compliance with pharmacovigilance regulatory obligations. November 15, 2001. Available at: www.emea.eu.int/pdfs/human/phvwp/161801en.pdf. Accessed February 27, 2005.

European Commission. Volume 9—pharmacovigilance: medicinal products for human use and veterinary medicinal products. June 2004. Available at: http://pharmacos.eudra.org/F2/eudralex/vol-9/home.htm. Accessed February 21, 2005.

Medicines and Healthcare products Regulatory Agency. MHRA statutory pharmacovigilance inspection, version 1 (final). September 2005. Available at: www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con2018030.pdf. Accessed March 7, 2006.

European Commission. Guideline on monitoring of compliance with pharmacovigilance regulatory obligations and pharmacovigilance inspections (draft). March 2006. Available at: http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2006/02_2006/v9_compliance-guideline_pubcons_03–2006.pdf. Accessed March 19, 2006.

Current Challenges in Pharmacovigilance: Pragmatic Approaches. Report of CIOMS Working Group V. Geneva, Switzerland: Council for International Organizations of Medical Sciences; 2001.

10.

Department of Health and Human Services, US Food and Drug Administration. FDA issues final risk minimization guidances [talk paper]. March 24, 2005. Available at: http://www.fda.gov/bbs/topics/news/2005/NEW01169.html. Accessed June 5, 2005.

11.

Department of Health and Human Services, US Food and Drug Administration. Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Guidance for industry: good pharmacovigilance practices and pharmaco-epidemiologic assessment. Available at: www.fda.gov/cder/guidance/63590CC.pdf. Accessed June 5, 2005.

12.

Department of Health and Human Services, US Food and Drug Administration. Center for Drug Evaluation and Research Web page. Guidance documents. Available at: www.fda.gov/cder/guidance/index.htm. Accessed February 17, 2005.

13.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Web site. Available at: www.ich.org/UrlGrpServer.jser@_ID=276@_TEMPLATE=254. Accessed February 17, 2005 [currently available at www.ich.org/cache/compo/276–254–1.html].

14.

Council for International Organizations of Medical Sciences Web site. What Is CIOMS? Available at: www.cioms.ch/frame_what_is_cioms.htm. Accessed February 27, 2005.

15.

LAW.COM Web site. Fruit of the Poisonous Tree. Available at: http://dictionary.law.com/definition2.asp?selected=795&bold=%7C%7C%7C%7C. Accessed February 17, 2005.

16.

Department of Health and Human Services, US Food and Drug Administration. Center for Drug Evaluation and Research Web page. FOI warning letter g4355d. Available at: www.fda.gov/foi/warning_letters/g4355d.pdf. Accessed February 17, 2005.