Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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42 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Management engagement and support are essential to re- move the roadblocks resulting from lack of understanding. Clarity must be provided to highlight the need for compliance and to ensure the appropriate importance and urgency are given to meet deadlines imposed by the pharmacopoeias. It is impor- tant to enlist both regulatory and quality departments to aid in the effort to gain support from the overall organization. This difficulty with on-time compliance then becomes a regulatory and quality inspection risk. Another area that creates confusion for companies is that many consider pharmacopoeia publications only as qual- ity standards that are focused on analytical, physical, and microbiological test methodologies and their associated acceptance criteria for materials. However, as noted pre- viously, there are several general chapters related to pack- aging, storage, distribution, labeling, and quality systems that require assessment by appropriate SMEs in an orga- nization. It can be a challenge to engage and gain buy-in from the departments that support these other functional areas as well. Additionally, companies that manufacture combination products must deal with general chapters related to medical devices that are being published by many pharmacopoeias. Change control. It is instructive to return to the issue of change control and on-time implementation as they relate to pharmacopoeia compliance. One of the most difficult issues with maintaining compliance is the use of change control to implement new and revised items in the pharmacopoeias that will become official on a specified date. Compendial revi- sions 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 requirements is often not sufficient to fully and effectively implement the changes. Examples of complex changes are the ICH Q3C and Q3D guidance on residual solvents and elemental impurities, with the associated updates to the relevant general chapters in the pharmacopoeias. For bio/pharmaceutical companies, it is expected that these changes are communicated and properly assessed by internal stakeholders in the impacted organizations before they are implemented. For a company that may manufacture the material at multiple locations with different registrations in countries around the world for that product, implement- ing 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 understands the need to use change control, as well as the amount of time that may be necessary to receive the proper assessments from all stakeholders. Typically, several meetings with multiple departments (e.g., regulatory affairs, quality, analytical technical support, stability) are needed to clarify all potential impact and to ensure this is properly documented in the change control. After the change control is approved, there is a need to have someone responsible to ensure the actions are completed by the official date. However, the ability to meet the official date can be compromised if updates to multiple national filings are required, causing implementation for a specific market to extend past the official date indicated by the pharmacopoeia. This difficulty with on-time compliance then becomes a regulatory and quality inspection risk. A company's strategy should be documented in the change control indicating how the material will be released during this change transition (e.g., duplicate testing until country approvals are received, or release after notification to the appropriate health authority). It is critical that the quality control, quality assurance, and regulatory groups are aware of and agree with the strategy. Conclusion In previous articles in this series, the basis for compendial compliance expectations was provided, along with a com- prehensive, end-to-end framework to better understand the external and internal challenges faced by the bio/phar- maceutical industry in trying to meet pharmacopoeia re- quirements. The next articles in the series will explore the history of the many pharmacopoeias around the world and the need for harmonization, to establish consistent, global pharmacopoeia standards. Subsequent articles will address the creation of effective compendial processes, including that for review of pharmacopoeia updates, to help the in- dustry meet health authority expectations to comply with pharmacopoeia requirements, and deliver quality medicines that extend and improve the lives of patients worldwide. Acknowledgment The authors gratefully acknowledge the contribution of Susan J. Schniepp for her technical review and helpful sug- gestions during the preparation of this series of articles. References 1. N. A. Schwarzwalder and R. H. Bishara, American Pharmaceu- tical 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 Con- vention, 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 (MHRA), 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 Octo- ber 31, 2017). PT Pharmacopoeia Compliance Series

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