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34 BioPharm International eBook September 2019 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series One of the most difficult issues w it h ma i nt a i n i ng compl ia nce is the use of change control to implement new and revised items in the pharmacopoeias that will become of f ic ia l on a spec if ied date. Compendial revisions can be complex, and the short time available from the publication of new and revised official changes to the date when companies must comply with the updated require- ments is often not sufficient to fully and effectively implement the changes. Examples of com- plex changes are the ICH Q3C and Q3D g uidance on residual solvents and elemental impuri- ties, with the associated updates to the relevant general chapters in the pharmacopoeias. For bio/pha r maceut ica l com- panies, it is expected that these changes are communicated and prop e rly a s s e s s e d b y i nte r n a l stakeholders in the impacted orga- nizations before they are imple- mented. For a company that may manufacture the material at mul- tiple locations with different reg- istrations in countries around the world for t hat produc t, imple - menting changes that result from new and revised monographs for a drug substance or product can grind the processes to a halt. It is important to recognize this issue and to ensure management under- stands the need to use change control, as well as the amount of time that may be necessary to receive t he proper assessments from all stakeholders. Ty p i c a l l y, s e v e r a l m e e t i n g s with multiple departments (e.g., reg ulator y affairs, qualit y, ana- ly t ic a l te c h n ic a l s upp or t, st a - bilit y) are needed to clarif y all potential impact and to ensure this is properly documented in t he c h a nge cont rol. A f te r t he c h a n g e c o n t r o l i s a p p r o v e d , t he re is a ne e d to have some - one r e sp on sible to e n s u r e t he ac t ion s a r e c omple te d b y t he official date. However, the ability to meet the official date can be compromised if updates to multi- ple national filings are required, c au si n g i mple me nt at ion for a spec i f ic ma rket to e xtend past the official date indicated by the phar macopoeia. T his diff ic ult y w it h on-t i me compl ia nce t hen becomes a reg ulatory and qual- ity inspection risk. A company's strateg y should be documented in the change control indicating how the material will be released du r i ng t h i s c h a nge t r a n sit ion (e . g ., d u p l i c a t e t e s t i n g u n t i l countr y approvals are received, or release a f ter not i f icat ion to t he appropr iate hea lt h aut hor- ity). It is critical that the quality control, qualit y assurance, and reg u lator y g roups a re awa re of and agree with the strategy. For a company that may manufacture the material at multiple locations, implementing changes that result from new and revised monographs can grind the processes to a halt. CONCLUSION In previous articles in this series, the basis for compendial compli- ance expectations was provided, along with a comprehensive, end- to-end framework to better under- stand the external and internal challenges faced by the bio/phar- maceutical industry in trying to me e t ph a r m ac op o e i a r e qu i r e - ments. The next articles in the series will explore the history of the many pharmacopoeias around the world and the need for har- mon i z at ion, to e st abl i sh con- si ste nt, g loba l pha r macop o e ia standards. Subsequent articles will address the creation of effective compendial processes, including that for review of pharmacopoeia updates, to help the industry meet he a lt h aut hor it y e x p e c t at ion s to comply w ith pharmacopoeia requirements, and deliver qual- it y med ic ines t hat extend a nd i mprove t he l ive s of p at ie nt s worldwide. ACKNOWLEDGMENT The authors gratefully acknowl- edge the contribution of Susan J. Schniepp for her technical review and helpf ul suggestions during the preparation of this series of articles. REFERENCES 1. N. A. Schwarzwalder and R. H. Bishara, American Pharmaceutical Review 7 (4), pp. 53-57 (Jul-Aug 2004). 2. USP, General Notices and Requirements, pp. 3-12, USP 41-NF 36 (2018) (published by The United States Pharmacopeial Convention, 2017). 3. BP, British Pharmacopoeia, General Notices, Part II, pp. I-4 - I-19 (published by The Stationery Office on behalf of the Medicines and Healthcare Products Regulatory Agency, 2017) 4. M. Borer, "Pharmaceutical Reference Standards: Overview and Role in Global Harmonization," Presentation at 3rd DIA China Annual Meeting, Beijing, China (May 16-18, 2011). 5. FDA, Drug Manufacturing Inspections, Compliance Program Guidance Manual– Drugs (CDER), Chapter 56: Drug Quality Assurance, Program No. 7356.002 (Implementation Date October 31, 2017). BP