Issue link: https://www.e-digitaleditions.com/i/1495138
www.biopharminternational.com Quality and Regulatory Sourcebook March eBook 2023 BioPharm International ® 21 Validation 24. Kovacs, E. et al. Analytical Control Strategy, USP Stimuli Article. Pharmacopeial Forum 2016 42(5), 25. Weitzel, J. et al. Measurement Uncertainty for the Pharmaceutical Industr y, USP Stimuli Article. Pharmacopeial Forum 2018 44(1). 26. Schofield, T. et al., Distinguishing the Analy t- ical Method f rom the Analy tical Procedure to Support the USP Analytical Procedure Life Cycle Paradigm, USP Stimuli Ar ticle. Pharmacopeial Forum 2019 45(6). 27. Schweitzer, M. et al., PharmTech. 2010 34 52–59. 28. USP. USP Genera l Chapter <1220>, "Ana ly tica l P r o c e du r e L i f e c yc le ," U S P – N F 202 2 I s s u e 1 (Rockville, MD, 2022). 29. Ermer, J. et al., J Pharm Biomed Anal. 2020 181 https://doi.org/10.1016/j.jpba.2019.113051. 30. BP. Supplementary Chapter on the use of Analyt- ical Qualit y by Design Concepts for Analytical Procedures, BP 2022. 31. MHRA. MHRA Response and Strategy for the Ap- plication of Analytical Quality by Design Concepts to Pharmacopoeial Standards for Medicines, 2020. 32. MHRA. Technical Review of MHRA Analy tical Quality by Design Project, 1–27 (MHRA, 2019). 33. Da n ish Med ici nes Agenc y. Groups of exper t s and working parties under the EDQM [Internet]. 2022 [cited 2022 Oct 5]. Available from: https:// laegemiddelstyrelsen.dk/en/licensing/supervi- sion-and-inspection/standardisation-of-the-quali- ty-of-medicines-in-europe/groups-of-experts-and- working-parties-under-the-edqm/ 34. Fei nberg, M. et a l., A nal Bioanal C hem . 2004 380 502–514. ht t ps://doi.org/10.1007/s00216- 004-2791-y. 35. F D A . G u i d a n c e f o r I n d u s t r y , A n a l y t i c a l Procedures and Methods Validation for Drugs and Bi- ologics (2015). 36. USP. USP General Chapter <1225>, "Validation of Compendial Procedures," USP–NF 2022 Issue 1 (Rockville, MD, 2022). 37. USP. USP General Chapter <1226>, "Verification of Compendial Procedures," USP–NF 2022 Issue 1 (Rockville, MD, 2022). 38. USP. USP General Chapter <1224>, "Transfer of A na ly t ica l Procedures," USP –NF 2022 Issue 1 (Rockville, MD, 2022) 39. USP. USP General Chapter <1210>, "Statistical Tools for procedure Validation," USP–NF 2022 Issue 1 (Rockville, MD, 2022). 40. USP. USP General Chapter <1039> "Chemometrics," USP–NF 2022 Issue 1 (Rockville, MD, 2022). 41. USP. USP General Chapter <1010>, "Analytical Data– Interpretation and Treatment," USP–NF 2022 Issue 1 (Rockville, MD, 2022). ■ Somnath Mishra, President, Shabas Solutions LLC FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations In this episode of the Drug Solutions Podcast, Chris Spivey interviews executives at Shabas Solutions LLC, who ran the overseas quality management maturity (QMM) pilot project. FDA has pointed to a lack of manufacturer in- centives to improve their quality management beyond the minimum required for current good manufacturing practice compliance. Learn what QMM is, and how far beyond GMP functions QMM will drill into, and what account- ability senior management bears for sustaining a corporate quality management culture. For more podcast episodes, visit PharmTech.com. SCAN ME