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Page 28 of 42 eBook December 2019 BioPharm International 29 • C ompa ny le ade r sh ip/f u nc- tional area management • Pharmaceutical industry asso- ciations. The critical role played by the compendial affairs group in the over- all process was presented earlier. The internal stakeholders, working indi- vidually as SMEs or as part of a team, and those functional areas that are impacted by specific pharmacopoeia revisions are also necessary in the process. These resources reside over the entire company, as identified earlier in the detailed description of the surveillance process. These SMEs must clearly understand their role in the compendial process, whether it be technical assessment or driv- ing the implementation of a change across the company. Without clearly defined roles and responsibilities, items may not be properly assessed or implemented. The engagement of internal SMEs and impacted stake- holders is critical to the effectiveness and sustainability of the compen- dial affairs process. Additionally, to effectively manage changes in the national pharmacopoeias, engage- ment with the local contact group or in-country partner is vital, due to the challenges of irregular revision schedules and the potential need for translation. To be truly successful in the overall effort, the entire pro- cess and all the people involved need the support of company leadership and functional area management, who must be aware of the time com- mitment needed to properly assess a revision, develop appropriate com- ments, or drive implementation of the change that potentially affects multiple sites, products, and registra- tions. This time commitment is not trivial and adequate resources need to be available to ensure ongoing compliance with pharmacopoeial requirements. All of the groups mentioned are internal to a company, but the dis- cussion of people that support the surveillance process is not com- plete without consideration of a key external connection: phar- maceutical industry associations. These associations may be found in many countries and regions around the world and a list of some key industr y g roups that monitor the pharmacopoeias are included in Table I. The value gained by a company through connecting with the com- pendial interest or discussion groups in these industry associations should not be underestimated. It should be noted that these groups do not talk about pharmacopoeia changes that impact only one or a few compa- nies, such as specific monographs for drug products or ingredients. Rather, Regulatory Sourcebook Pharmacopoeia Compliance Series Acronym Association name United States NJPQCA New Jersey Pharmaceutical Quality Control Association MWCDG Mid-West Compendial Discussion Group WCDG Western Compendial Discussion Group PhRMA Pharmaceutical Research and Manufacturers of America BIO Biotechnology Innovation Organization AAM Association for Accessible Medicines CHPA Consumer Healthcare Products Association United Kingdom ABPI Association of the British Pharmaceutical Industry Europe EFPIA European Federation of Pharmaceutical Industries and Associations EBE European Biopharmaceutical Enterprises Japan JPMA Japan Pharmaceutical Manufacturers Association China RDPAC R&D-Based Pharmaceutical Association Committee International IFPMA International Federation of Pharmaceutical Manufacturers & Associations IGBA International Generic and Biosimilar Medicines Association IPEC* International Pharmaceutical Excipients Council GSCF Global Self-Care Federation PDA Parenteral Drug Association * The IPEC Federation is a global organization consisting of IPEC Americas, IPEC China, IPEC Europe, IPEC Japan, and IPEC India. Table I. Pharmaceutical industry associations engaged in surveillance of pharmacopoeia revisions. Contin. on page 35

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