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www.biopharminternational.com March 2020 BioPharm International eBook 15 standards to help ensure the quality of medicines" (8). The GPhP guid- ance continues, "Pharmacopoeial monographs provide an important tool for assurance of the quality of marketed pharmaceutical ingredi- ents and products through testing of their quality." These monographs are generally available for excipients, drug substances, and drug products, providing the tests, analytical pro- cedures, and acceptance criteria that enable assessment of the quality of the material. Taken together with the other requirements contained in the pharmacopoeia, these mono- graphs can help safeguard the health of patients around the world through the availability of public quality standards. The bio/pharmaceutical indus- try is focused on delivering quality products to patients. Earlier in this series of articles, the content of the pharmacopoeia was described with consideration of the impact of the pharmacopoeia throughout the life- cycle of a drug product (1). From a practical business perspective, the value and benefit of the pharmaco- poeia content to a specific company may vary based on the sector in which the company operates (e.g., innovator, generic-drug company, contract manufacturer) and the spe- cific pharmacopoeia content under discussion. General chapters The general chapters in the phar- macopoeias provide a wide range of information, including analytical and biological procedures that are used to test materials and products. It is broadly agreed these general chapters are beneficial for all bio/ pharmaceutical companies because they facilitate product development, enabling greater focus on specific attributes that are critical to the quality of a material or product. These procedures, whether a sim- ple test for loss on drying for an exc ipient, or a microbiolog ica l test for a drug substance, or a dis- solution test for a tablet formu- lation, enable routine testing by providing details on how to per- form the test and, in some cases, the applicable acceptance criteria. Importantly, the information in pharmacopoeia general chapters is broadly accepted as an appropri- ate quality standard by regulatory authorities around the world. Excipients There is also general agreement across the industry regarding the value and benefit of having spe- cific tests and acceptance crite- ria contained in monographs for excipients. From the perspective of excipient suppliers, the avail- ability of a monograph provides a quality standard for the material that should be acceptable to mul- tiple customers. For bio/pharma- ceutical companies, the benefits include having multiple suppli- ers that can prov ide excipients meeting the same core require- ments, simplifying the sourcing of these materials, and reducing the burden of laboratory assess- ments to determine comparabil- it y of mater ia ls f rom a lter nate sources. E xcipient monog raphs a l s o fac i l it ate com mu n ic at ion with health authorities regarding excipient quality attributes. Using compendial-grade excipients in drug products aligns with regula- tory expectations for review and inspection, simplif ying product reg istrations by allow ing refer- ence to the pharmacopoeia mono- graph as the standard of quality for the material. Referencing the monograph eliminates the need to include specific acceptance crite- ria, methodology, and validation information for the excipient in the drug product registration. Drug substances and products Divergent perspectives begin to emerge across the industry when considering the value and benefit of specific monographs for drug substances and dr ug products. Monographs for small-molecule drug substances and products have long been established in the pharmaco- poeias, and the quality requirements in the monographs apply to both innovator and generic-drug com- panies alike. These monographs, however, do not typically become available until later in the drug prod- uct lifecycle. Indeed, the new drug substances and products must first be discovered and developed by an innovator company, and the appli- cable monographs follow. The initial quality requirements are approved by health authorities as submitted in new drug applications. Generic drugs As with the innovator company, drug substance and product mono- graphs are generally not available for those generic-drug companies that are first to enter the market; prod- uct development work is typically well underway before specific mono- graphs are available for the materi- als. The value of the monographs emerges with the approval of sub- sequent generic versions, helping to ensure consistent quality, especially as the availability of the product grows across today's global supply chain. It is here that the ultimate value for patients is realized, with the quality standard in the mono- graphs for the drug substance and product applying to all companies. Biologics and vaccines There is, perhaps, even less agree- ment throughout the industry on the value or benefit of monographs for biological products and vaccines. The pharmacopoeias, and in partic- ular the European Pharmacopoeia (Ph. Regulatory Sourcebook Pharmacopoeia Compliance Series