Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 51 • Training • New responsibilities • Reorganizational aspects • Addition of staff • Updated job descriptions • Signatory aspects of protocols, SOPs, etc. • Revision of contracts • Cost of adding requirements for accreditation of ani- mal facilities • Amending reports to change archive location. The WG concluded that the proposed regulations may limit the number of companies that will be able to execute nonclinical studies in a compliant manner because of cost. Dilution of the role of the study director and introduction of new roles. The role of the study director, the single point of study con- trol, has been diluted and responsibilities duplicated with other personnel. New roles, as proposed, add more organizational complexity, which directs an overreach in some responsibilities (e.g., management with executive responsibility). New signatory requirements could unnecessarily delay initiation, execution, and reporting of nonclinical regulated studies. Inclusion of the Animal Welfare Act and Regulations. Animal Wel- fare Act and Regulations should be excluded from the mod- ernized GLP regulations. Animal welfare activities already are covered by the Animal Welfare Act and are governed by US Department of Agriculture (USDA); and their inclusion in the proposed rule changes will not advance a purpose distinct from USDA regulations already in place. Changing the traditional, independent role of the QAU. The pro- posal for FDA to extend their authority to inspect all QAU re- cords "when necessary" to ensure compliance will negatively impact the interrelationship between management, study director, principal investigator, and QAU. Introduc tion of additional roles and responsibilities to align with the quality systems approach. The proposed regulations are overly prescriptive regarding company infrastructure to support study conduct rather than providing a f lexible framework to allow large and small organizations to design and conduct GLP studies. Additional dialogue with industry needed Compliance with FDA regulations in the conduct of non- clinical laboratory studies is an important process that helps ensure the quality and integrity of data derived from safety studies, the protection of human subjects, and mar- keting decisions based on accurate and reliable data. The 2016 proposed rule changes, as written, did not provide an improved framework for modernization that offered phar- maceutical companies f lexibility, and did not help improve the quality, planning, conducting, and reporting of non- clinical laboratory studies. Because of the importance of these regulations to indus- try, IQ GLP LG in January 2017 requested FDA withdraw the 2016 proposed rules and open a dialogue with industry representatives for review and comment before revised the proposed GLP regulations becomes final. FDA to date has not issued a revision to the GLP regulations. Summary The consolidated quality expertise offered by the working groups of IQ allow the organization to avoid redundancies of efforts; benefit from the experience and expertise of dif- ferent disciplines to enable innovative drug development ap- proaches that are compliant and meet global quality require- ments; and provide an avenue to interact with regulators to positively inf luence guidance documents and implemen- tation of novel approaches. The QCC was key in initiating the creation of the Regulatory Advisory Committee, which provides expert advice to any IQ team that needs guidance in developing justifications for pro-active engagement with regulators in seeking scientific advice. References 1. J. Lippke, et al., Pharm Tech 44 (8) 51–54 (August 2020). 2. MHRA, GXP Data Integrity Guidance and Definitions (London, UK, March 2018) 3. FDA, Data Integrity and Compliance with Drug cGMP – Ques- tions and Answers (Rockville, MD, December 2018) 4. IQ Consortium, "IQ Data Integrity WG Risk Assessment Tool," www.iqconsortium.org, Aug. 3, 2020. 5. FDA, "Good Laboratory Practice for Nonclinical Laboratory Studies," Notice, Federal Register, 81 FR 58341, 58341-58380. PT About the authors Ganapathy Mohan*, Ganapathy_mohan@merck.com, is ex- ecutive director, global quality compliance, Merck & Co., Inc., Kenilworth, NJ, USA.; Christopher Turner is associate direc- tor, quality laboratory practices, Bristol Myers Squibb; Dennis O'Connor is senior associate director, GMP QA, Boehringer Ingelheim; Lisa Fink is senior quality technical consultant (retired), Baxter Healthcare Corporation; Thomas Purdue is quality analyst V, Boehringer Ingelheim; Jeffrey Beebie is di- rector and GLP QA team lead, Pfizer, Inc.; Kerri Robles is di- rector, quality laboratory practices, Bristol Myers Squibb; and Karen Waetjen is director, GCP/GLP Compliance, Amgen; all authors are members of the IQ Consortium. *To whom all correspondence should be addressed. Any steps taken to mitigate a data-integrity risk should be assessed to determine its appropriateness in the context of the criticality of the gap between desired and actual practice.

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