Strategies for Validation Extensions - It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements. - BioPharm International

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Strategies for Validation Extensions
It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.


BioPharm International


References

1. International Conference on Harmonization. Q2(R1), Validation of analytical procedures: text and methodology. Geneva, Switzerland; 2005, Nov.

2. The Fitness for Purpose of Analytical Method, Eurachem Teddington, UK; 1998. http://www.eurachem.ul.pt/guides/valid.pdf

3. Traceability in Chemical Measurement, Eurachem/CITAC. Teddington, UK; 2003. http://www.eurachem.ul.pt/guides/ EC_Trace_2003.pdf .

5. US Food and Drug Administration. Draft guidance for industry. Analytical procedures and methods validation. Rockville, MD; 2000.

6. Parenteral Drug Association. Technical Report 33, evaluation, validation and Implementation of new microbiological testing methods. Bethesda, MD.

7. European Pharmacopeia. Alternative methods for control of microbiological quality. Supplement 5.5 [07/2006:50106] (December 2005).

8. Krause SO. Validation of analytical methods for biopharmaceuticals—A guide to risk-based validation and implementation strategies. PDA/DHI Publishing; 2007, Apr.

9. US Food and Drug Administration. Guidance for industry PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance, Rockville, MD; 2004.

10. ISPE Good Practice Guide: Technology Transfer. International Society for Pharmaceutical Engineering. 2003; Tampa, FL.

11. Statistical Principles for Clinical Trials, ICH E9 (1998). http://www.emea.eu.int/ pdfs/human/ich/036396en.pdf.

12. Points to Consider on Switching Between Superiority and Non-Inferiority, CPMP (2000). http://www.emea.eu.int/pdfs/ human/ewp/ 048299en.pdf.

13. Points to Consider On The Choice Of Non-Inferiority Margin, CPMP (2004).


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