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www.biopharminternational.com September 2019 BioPharm International eBook 21 Regulatory Sourcebook Pharmacopoeia Compliance Series Me d ic a l D ev ices i nd ic ates t he need for compl ia nce w it h t he Japanese Phar macopoeia ( J P) i n order to standardize and control the quality of drugs. The legal and reg ulator y f ramework for phar- macopoeia compliance in these and other countries can be found in a useful summary prepared by the World Health Organization ( W H O) i n c o nj u n c t i o n w i t h recent International Meetings of World Pharmacopoeias (IM W P) (1). This information, with appro- priate updates by the authors, is prov ided for several countr ies/ regions in Table I, along with a list of the authorities that have respon- sibility for publishing the associ- ated pharmacopoeias. In an article published in 2004 on the bio/pharmaceutical indus- try's pharmacopoeial surveillance process (2), the need to remain compliant with "current" compen- dial requirements was emphasized to ensure updated standards are incor porated into a company 's testing procedures. If there is no process for surveillance, or if the process is ineffective in identify- ing and addressing compendial changes, the resulting lack of com- pliance may be listed in regulatory observations. Specific examples from FDA 483s are included in the article, with observations such as: "… the firm did not follow the cur- rent USP specifications … failed to implement changes to testing methodology as required by USP … and did not address raw material monograph updates." Examples of more recent compendial com- pliance obser vations f rom FDA 483s are summarized in Table II. The common theme in all these observations is the need to main- tain alignment w ith applicable ph a r m ac op o e i a r e qu i r e me nt s, even as the requirements change ove r t i me. Si m i la r r eg u lator y expectations to comply with cur- rent pharmacopoeia requirements can be found in Europe, Japan, and other countries, because the regulatory and compendial land- scape is truly global. A review of data from inspections conducted by the European Directorate for t he Q ua l it y of Med ic i nes a nd H e a lt h C a r e ( E D QM ) b e t we e n 2006 and 2018 includes compli- ance issues with Ph. Eur. general methods and general monographs among the deficiencies observed (3). The takeaway message is clear; compa n ie s mu st comply w it h comp e nd ia l re qu i re me nt s a nd must also remain up to date with changes made to the requirements. This ongoing revision to the phar- macop o e ia s a rou nd t he world poses one of the main challenges for companies and will be further addressed in later articles in this series. Companies must comply with compendial requirements and must also remain up to date with changes made to the requirements. PURPOSE AND CONTENT OF PHARMACOPOEIAS H av i n g h ig h l ig hte d t he ne e d t o c o m p l y w i t h c o m p e n d i a l requirements, with examples of observations resulting from non- compliance, it is helpful to have an overall understanding of the role pharmacopoeias play to support the availability of medicines. This understanding may be found in the history, purpose, and content of pharmacopoeias. Many of the pharmacopoeias from around the world have met during the past several years, under the guidance of WHO, to discuss collaboration and harmonization in today's glo- balized compendial, reg ulator y, and supply sit uation for dr ugs. The main suggestion to come out of these meetings was the devel- opment of Good Pharmacopoeial Practices (GPhP) recently published by WHO (4). WHO's GPhP states, "The pri- mary objective of the GPhP guid- ance is to define approaches and policies in establishing pharmaco- poeial standards with the ultimate goal of harmonization" (4). This focus on compendial harmoniza- tion is reflected in the origins of several of the pharmacopoeias (to be detailed in another article in this series) and is critical to the ongoing goal of providing medi- cines with consistent quality to patients around the world. The WHO document goes on to list the purpose and role of the phar- macopoeias: "A pharmacopoeia's core mission is to protect public health by creating and mak ing available public standards to help ensure the quality of medicines. Pharmacopoeia standards support regulatory authorities in control- ling the quality of pharmaceutical substances, their finished phar- maceutical products (FPPs), and related materials and will provide a tool with which the user or pro- curer can make an independent judgment regarding quality, thus safeg uarding the health of the public." A search through the pharma- copoeias reveals that they contain general notices, general chapters, ge ne r a l mono g r aph s, s p e c i f ic monographs for dr ug products,