Evaluating Risk-Based Specifications for Pharmaceuticals - Pharmaceutical Technology

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Evaluating Risk-Based Specifications for Pharmaceuticals
The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.

Pharmaceutical Technology
Volume 37, Issue 7, pp. 54-60

1. Article 3, Council Directive 83/570/EEC Amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the Approximation of Provisions Laid Down by Law, Regulation or Administrative Action Relating to Proprietary Medicinal Products.

2. FDA, Pharmaceutical cGMPs for the 21st CenturyA Risk-based Approach Final Report (Rockville, MD, Sept. 2004).

3. FDA, Guidance for Industry–PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, Sept. 2004).

4. FDA, Guidance for Industry–Process Validation: General Principles and Practices (Rockville, MD, Jan. 2011).

5. FDA, Guidance for Industry–Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (Rockville, MD, Oct. 2006).

6. United States of America vs. Barr Laboratories, US District Court for the District of NJ, Civil Action 92-1774, Opinion, A.M. Wolin (Feb. 4, 1993).

7. ISO Guide 35:2006 Certification of Reference Materials-General and Statistical Principles (Geneva, 2006).

8. USP, Scope of Accreditation to ISO Guide 34:2009, http://www.usp.org/sites/default/files/usp_pdf/EN/aboutUSP/us_iso_guide_34_scope_of_accreditation.pdf, accessed June 4, 2013.

9. ISO Guide 34: 2009 General Requirements for the Competence of Reference Material Producers (Geneva, 2009).

10. EDQM, "Quality, Safety Environment," webpage, http://www.edqm.eu/en/EDQM-quality-safety-76.html, accessed June 4, 2013.

11. C. Burgess and.R.D. McDowall, "Introduction to Raw Data, Results and Reportable Values," presented at the European Compliance Academy (2011).

12. M. Thompson and R J. Howarth, Analyst 105 (1257, 1188-1195 (1980).

13. G. Taguchi, "System of Experimental Design, Engineering Methods to Optimize Quality and Minimize Costs" (Quality Resources and American Supplier Institute, 1991).

14. ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology (1995).

15. J. Ermer and J.H. McB. Miller, Eds., Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (Wiley-VCH, Weinheim, Germany, 2005), p. 30.

16. ISO 14253-1:1998 Geometrical Product Specifications (GPS)—Inspection by Measurement of Work Pieces and Measuring Equipment—Part 1: Decision Rules for Proving Conformance or Non-conformance with Specifications (Geneva, 1998).

17. ASME, B89.7.3.1-2001, Guidelines For Decision Rules: Considering Measurement Uncertainty In Determining Conformance To Specifications (2001).

18. ASME, B89.7.3.2-2007 Guidelines for the Evaluation of Dimensional Measurement Uncertainty (2007).

19. A. E. Eagle, Ind. Qual. Control 10 (3) 10-15 (1954).

20. F. E. Grubbs and H.J. Coon, Ind. Qual. Control 10 (3) 15-20 (1954).

21. M.L.J. Weitzel and W.M. Johnson, Accredit. Qual. Assur. 17 491-495 (2012).

22. EURACHEM/CITAC Guide CG 4: Quantifying Uncertainty in Analytical Measurement (3rd Ed., 2012), QUAM:2012.P1

23. ISO/IEC/BIPM Guide to the Expression of Uncertainty in Measurement (GUM) (1993), also ANCSL 2540-2-1997 in the US.

24. D. Jacobson-Kram and T. McGovern, Adv. Drug Delivery Rev., 59 (1) 38-42 (2007).

25. EC, 2002/657/EC, Commission Decision: Implementing Council Directive 96/23/EC Concerning the Performance of Analytical Methods and the Interpretation of Results (Aug. 12, 2002).

26. EURACHEM/CITAC Guide: Use of Uncertainty Information in Compliance Assessment (1st Ed, 2007).

27. ICH, Q1E, Evaluation of Stability (2003).


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