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www.biopharminternational.com March 2020 BioPharm International eBook 39 Scope A company needs to decide which pharmacopoeias are in scope for t he i r c omp e nd i a l a f f a i r s pro - gram (purple bubble in Figure 1). To assist in this determination, one a r t ic le prese nte d t he h is - tory of the pharmacopoeias and how they have evolved over time, especially in the past 200 years (3). A common thread was high- lighted, that the formation of a new pharmacopoeia was histori- cally driven by the need for con- sistent sta nda rds t hat ensu red pat ie nt s re ce ive d h ig h- qu a l it y med ic ines. T he case was made for today's need for global har- monization of the standards in t he pha r macopoeias to benef it global patients (4). The inconsis- tency of the standards adds extra work and complexity for a com- pany to comply. An aspirational goal of a "world where there is no need for translation" was intro- duced as the ultimate outcome of any global harmonization activ- ities (4,12). The current state of harmonization activities was dis- cussed, including efforts by the Pharmacopoeial Discussion Group ( P D G) a nd t he I nte r n at io n a l Council for Harmonization (ICH), as well as t he concept of pro - spective har monization, which ref lec ts a pa r t nership bet ween the industry and pharmacopoe- ias and is supported by the Good Pharmacopoeial Practices guidance (5,13). Definitions for global and national pharmacopoeias were pro- vided (6) to help an organization define which pharmacopoeias are in scope for their surveillance pro- cesses. The breadth of the com- pendial affairs program is directly related to the decision made by a company of which pharmacopoe- ias will and will not be reviewed. New regulations emerge, existing regulations change, and unexpected problems arise that require all stakeholders to evolve, including the pharmacopoeia. Teamwork T h r o u g ho ut t he a r t ic le s , t he authors referred to the people, processes, and tools needed for the compendial affairs activities. Teamwork within the organization (blue bubble in Figure 1) is the most critical aspect to ensure efficient processes and successful outcomes for a central compendial affairs function. The need for cross-func- tional support within the com- pany was specified as critical to ensuring the success of a specific process. Without teamwork, advo- cacy efforts to comment on pro- posals or to implement an official revision to remain compliant will not happen. It is critical that the company develop an end-to-end perspective to maintain compen- dial line-of-sight, understanding how the efforts of every part of the organization affect the outcomes that are achieved. The entirety of the compendial processes become almost impossible to sustain with- out teamwork in an organization. In summary, the ultimate objec- tive of these articles was to pro- vide a thorough understanding of compendial challenges and oppor- tunities for those involved in the work, and to help educate others in their company on the impor- tance of the activities. The articles contribute ideas and suggestions to help companies avoid recreating the wheel and assist in develop- ing best practices for bio/pharma- c e ut ic a l comp a n ie s to e n s u r e compliance with compendial and regulatory requirements. Meeting these compliance goals enables on-time delivery of high-quality medicines for patients around the world, f ulfilling the mission of every health authority and phar- macopoeia, as well as the entire bio/pharmaceutical industry. WHAT IS ON THE HORIZON New reg ulations emerge, ex ist- i n g r e g u l at i o n s c h a n g e , a n d unexpected problems arise that require all stakeholders to evolve, i nc lud i ng t he pha r macopoeia. Schwarzwalder and Bishara (14) desc r ibed t h is consta nt evolu- tion, pointing out that a compen- dial affairs function must look at potential changes that are being evaluated by the pharmacopoeia authorities for implementation in the future. As noted in a previ- ous article in this series (6), there are many reasons that can spur changes to the pharmacopoeia. Some additional examples include: • Contamination issues, such as glycerin contaminated with diethylene glycol (15), heparin contaminated with oversu l fated chond roit i n sulfate (16), or nitrosamines found in sartans, a class of drug products used to treat high blood pressure (17). Each incident has led to sig- nificant safety concerns, with new tests and controls being added by the pharmacopoeia. • Continuing harmonization efforts between global and national pharmacopoeias. Regulatory Sourcebook Pharmacopoeia Compliance Series