Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

Issue link:

Contents of this Issue


Page 36 of 54

Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 37 compliance within the impacted sites and functional areas that must meet the compendial requirements published by the phar- macopoeias when they become official. Between the strategy and implementation functions are the critical surveillance ac- tivities, which include review of new and revised compendial requirements, initially at the proposal stage and subsequently when they become official and enforceable. The work done during compendial surveillance provides an opportunity for advocacy; although in this case, it is in reaction to the proposed revisions. In the authors' experience, the upstream, proactive advocacy is often more effective than the reactive, downstream advocacy in influencing the outcome of compendial changes. Surveillance also provides the ability to plan for implementation when the pharmacopoeia updates become official, which can be very beneficial to help ensure on-time compliance. This high-level overview of compendial activities, however, does not convey the significant effort required to establish and maintain compliance with current compendial requirements. A comprehensive, detailed picture of this work is provided in Figure 1. With the ultimate and essential goal being compendial compliance, it is instructive to explore the details looking first at the final stages of the overall process. In the authors' experience, the majority of compendial changes impact central or site testing standards that are used to ensure the quality of pharmaceutical products and their in- gredients. Some compendial changes may also impact central or local procedures, including those in functional areas such as packaging, labeling, storage, distribution, and even research and development. These changes resulting from new or revised compendial requirements are usually implemented according to change control procedures established by the company. For quality document updates, revisions typically occur within a global change-management system, which is separate from compendial systems, although each system and process needs to provide visibility to the other to ensure no compliance gaps emerge. Change control should require the compendial revisions to be reviewed by all impacted stakeholders, and in particular those in regulatory/chemistry, manufacturing, and controls (CMC) functions who have visibility to the global reg- istrations for the company's product portfolio. Compendial changes represent only one type that are typically brought into the change control process, which also includes changes driven by regulatory and manufacturing process updates. Compendial changes often put additional strain on systems and processes that are utilized to implement the necessary revisions on time, given the complex supply and regulatory environment for bio/ pharmaceutical companies. Upstream from the compliance function are the surveillance activities, which encompass the review of compendial updates at the proposed and official stage. Effective surveillance requires the appropriate processes, people, and tools to enable compli- ance. As shown in Figure 1, this work is based upon user-centric partnerships and teams to develop and execute implementa- tion plans for ongoing compendial compliance. As mentioned earlier, the surveillance activities also provide an advocacy opportunity to respond and potentially influence the course of compendial revisions. Further upstream are the strategy activities that help enable compliance through proactive engagement with the phar- macopoeias. This work includes the submission of new and revised monographs and chapters for consideration by the pharmacopoeias, as well as involvement with pharmaceutical Monograph Development (Prospective Harmonization) C-LOS National Pharmacopoeias (Japan, Brazil, Russia, India, China, Korea) 6 Critical Markets Methods/ Specifications: RFT Strategy: Proactive Compliance External Advocacy Regulatory ∆ Implementation Global Pharmacopoeias (USP, EP, BP) Acceptable in >150 Countries Plan Plan Execute Review: Proposals Review: Official Compendial Review Process Surveillance Teams and Partnerships to develop and execute implementation plans for ongoing compendial compliance. Also: Opportunity for Advocacy. Compendial ∆ Implementation Compliance Process ∆ Implementation Change Control (Quality, Sites, Regulatory) Figure 1. Compendial end-to-end process. FIGURE COURTESY OF THE AUTHORS

Articles in this issue

Archives of this issue

view archives of Pharmaceutical Technology - September 2019 - Pharmaceutical Technology - Regulatory Sourcebook