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