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www.biopharminternational.com eBook December 2019 BioPharm International 37 Regulatory Sourcebook Pharmacopoeia Compliance Series robust filter and reduce the number of items that require further assess- ment. Typically, a spreadsheet can be used to establish this matrix of gen- eral chapters across pharmacopoeias, with an indicator if the chapter is applicable to the company. The list requires periodic follow up to add new general chapters and remove others that have been made obsolete. Communication tools are also important for a successful surveil- lance program, to provide the find- ings of the ongoing pharmacopoeia filtering process throughout the company and enable assessment for potential impact. This includes communication of individual items and an overview report sent at a regular frequency (per publication, monthly, or quarterly). Microsoft Word programs and Microsoft Excel spreadsheets are the typical tools used for such reports. The compen- dial affairs function needs to keep up-to-date lists of SMEs and other stakeholders for email distribution of necessary reports or task assign- ments. Having a dedicated email box for the compendial affairs function is also a recommended best practice for communication. This alleviates individuals in the company from having to know a specific person in the compendial affairs role and allows for people changing their roles and responsi- bilities. Most people can remember a well-named email address (e.g., C ompend ia lsuppor t @ compa ny. com) more easily than a specific individual's name. This generic email address allows all members of the compendial function to moni- tor requests and questions that may be sent to them from any group in the company. I f a c omp a ny 's c omp e nd i a l affairs function submits responses t o p h a r m a c o p o e i a p r o p o s a l s , then a process for this needs to be defined. Typically, responses are submitted on company let- terhead a nd sent v ia ema i l to t he ph a r m ac op o e i a aut hor it y or a specific scientific liaison in t he ph a r m ac op o e i a or g a n i z a - tion. The file is usually submitted i n p or t able do c u me nt for m at (PDF) with electronic signature to maintain the integrity of the file, which also serves as the offi- c i a l r e cord of t he comp a ny 's position on the particular issue. Some pharmacopoeias have online platforms that allow comments to be directly uploaded to that site. It is expected that other pharma- copoeias will follow suit in the coming years. Also, it is recom- mended that the tracking system, mentioned before, be configured so that submitted comments can be tracked to enable follow-up as needed. This also allows a deter- mination of whether the com- me nt s a nd s ug ge ste d c ha nge s subm it ted by a compa ny were taken into account in the offi- cial version for implementation. This also provides the compendial affairs function with the ability to generate metrics on the com- pany's effor ts to inf luence the pharmacopoeia authorities. The last essential tool for a com- pendial affairs program is a global change control system. Items that are published as official by the pharmacopoeias typically have a six-month window for implemen- tation from the time of publication. It is important that all appropriate functional areas within a company assess the impact and determine the implementation steps for the site or global function. Key to the change process is a reg ulator y impact assessment to determine if any product registrations need to be updated. A simple change in a monograph could still result in updates to registrations in several countries, determined by a com- pany's filing strategies. To have an effective change control process that drives on-time implementa- tion of a pharmacopoeia change, each site or global function must understand their role and execute it promptly. Also, a responsible per- son or group needs to be identified that will drive the change control from start to finish. This is a diffi- cult job for multi-site, multi-prod- uct changes, or changes that impact multiple registrations. It is import- ant for the responsible person to begin this process shortly after the proposal has been reviewed. If a company begins the implemen- tation process when an item is reviewed at the proposal stage, it will have done most of the assess- ment and planning before the item becomes official, when there is only six months to complete the imple- mentation (see Sidebar, Figure 3). Taken together, the tools sup- porting the compendial processes All appropriate functional areas within a company must assess the impact of pharmacopoeia changes and determine implementation steps for the site or global function, including possible updates to product registrations.