Pharmaceutical Technology - September 2021

Pharmaceutical_Technology_PTE_Regulatory_Sourcebook_September_2021

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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 33 Summary and conclusion Based on this review, it is apparent that there is no consis- tency of nomenclature or requirement for sampling and testing between either standard setting bodies or regula- tory agencies. Even when nomenclature terms are the same, their definitions are different. A statistically sound sampling plan is required under the GMPs and for compendial standards. While there is global recognition that correct sampling is essential for data integrity, this is not supported by a unified global process f low or technical glossary. In Par t 2 of t his paper, a proposa l w ill be made for a simplified process f low covering all four phases with definitions. Acknowledgements The author wishes to thank Lucy Botros, Bob McDowall, Margarita Sabater, and Jane Weitzel for helpful comments and suggestions during the preparation of this paper. References 1. K. H. Ebsbensen, Introduction to the Theory of Sampling (IM- PublicationsOpen, 2020). 2. J. W. Merks, Sampling and Weighing of Bulk Solids (Tran Tech Publications, 1985). 3. F. F. Pitard, Pierre Gy's Sampling Theory and Sampling Practice (CRC Press, 2nd Edition, 1993). 4. W. Horowitz, Pure and Applied Chemistry, 62(6) 1183–1208 (1990). 5. IUPAC, Compendium of Analytical Nomenclature, Definitive Rules, 1997, (Orange Book) 1998. 6. ASTM, Standard Guide for Defining the Test Result of a Test Method (2019). 7. WHO, Guidelines for Sampling of Pharmaceutical Products and Related Materials, Technical Report Series, No. 929, Annex 4 (2005). 8. C. Burgess, Valid Analytical Methods and Procedures (Royal Society of Chemistry, 2000). 9. C. Burgess, Pharm Tech, 41(10) 82–83, 92 (October 2017). 10. USP, USP General Notices and Requirements, 3.10. Applicability of Standards (November 2020). 11. USP, USP General Notices and Requirements, 7.10. Interpreta- tion of Requirements (November 2020). 12. USP, USP General Chapter <1010> "Analytical Data—Interpre- tation and Treatment, Pharmacopeial Forum, 46(4) 2020. 13. EC, EU Guidelines for Good Manufacturing Practice for Medici- nal Products for Human and Veterinary Use, Chapter 6: Quality Control (March 28, 2014). 14. CFR Title 21, Part 211.160 (Government Printing Office, Washington, DC). 15. United States v. Barr Laboratories, 812 F.Supp 458. (D.N.J 1993). 16. FDA, Guidance for Industry, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (CDER, Oc- tober 2006). 17. AAFCO, GOODSamples: Guidance on Obtaining Defensible Samples (October 2015). PT Next generation Raman imaging High performance Raman systems for a range of applications Visit www.renishaw.com/raman Renishaw, Inc. 1001 Wesemann Drive, West Dundee, Illinois, 60118, United States T +1 847 286 9953 F +1 847 286 9974 E raman@renishaw.com www.renishaw.com Raman spectroscopy produces chemical and structural images to help you understand more about the material being analyzed. Renishaw has decades of experience developing flexible Raman systems that give reliable results, for even the most challenging measurements. With Renishaw's suite of Raman systems, you can see the small things, the large things and things you didn't even know were there. AD216(EN)-01-A (For inc).indd 1 AD216(EN)-01-A (For inc).indd 1 12/20/2019 9:36:12 AM 12/20/2019 9:36:12 AM

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