Inclusion of relevant tests in the Pharmacopoeia to improve supply chain integrity (original) (raw)
Related papers
2021
Purpose: Pharmaceutical manufacturers execute quality control operations and Good Manufacturing Practices (GMP) to provide safe drugs. The Federal Drug and Food Administration (FDA) is tasked with ensuring manufacturers are performing such procedures. Faced with limited resources the FDA has developed novel tools to aid supply chain oversight. This paper briefly reviews these tools. Methods: Current inspection approaches employed by the FDA are identified by searching the FDA's guidelines, the Code of Federal Regulations, public reports and other online resources. Outcomes: Industry: A risk-based site selection model (SSM) is used to prioritize on-site inspections for FDA investigators. Theoretically, the SSM allows FDA investigators to focus on firms that are at high risk of failing to meet quality standards. Analytical testing of drugs is performed by FDA laboratories as well as manufacturers' laboratories. Despite this, two of the highest profile recalls in the last several years (Valsartan and Ranitidine) were not initially identified by the FDA. Instead, Valisure, an online pharmacy that tests each batch of inventory, detected the issues. Physicians and Consumers: The FDA has provided easy-to-use online tools for patient and physician reporting of drug quality problems. The FDA has also created consumer education campaigns to aid in protecting patients from fraud and counterfeiting. Conclusion: The FDA has developed novel methods of redistributing their workforce to maximize product quality and consumer safety with limited resources. The methods include a risk-based SSM for prioritizing on-site inspections, providing education tools, and online reporting of quality problems. FDA laboratories also provide analytical testing to ensure purity standards are met. The recent publicized discoveries of Valisure are leading other pharmacies such as the University of Kentucky Central Pharmacy to begin testing incoming drugs. It is critical for these pharmacies and the FDA to cooperate to protect the pharmaceutical supply chain moving forward.
Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance
2021
The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal products, including older medicines such as generic medicinal products with a well-established safety profile. For the latter, the risk management plans no longer contain important risks, considered important safety concerns, on the basis that routine pharmacovigilance activity would not allow their further characterisation. Society assumes that unexpected adverse reactions causally related to pharmacological activity are very unlikely to be detected for such well-established medicines, but important risks can still occur. For these products, a change in the safety profile which is brand or source specific and usually local in nature, associated with failures with the adequate control of qualit...
Journal of Pharmacopuncture, 2021
Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. Methods: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. Results: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twentyfive KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. Conclusion: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.
The Importance of Supplier Qualification for Vendors of Materials Used in in Vitro Assays
Pre-clinical assays, including in vitro assays, rely heavily on suppliers who provide specific products or services essential to the proper conduct of the study. The overall credibility of the assay and the results obtained from the assay are highly dependent on the quality of the supplies used. Variable results for the same control material over time could indicate that there is high lot to lot variability for a critical component of the assay. Monitoring positive and negative control results is one useful retrospective technique to help identify supplier quality. Instituting a supplier qualification program provides a prospective way to document that suppliers of critical products (such as the test system, critical media, or whole test kits) consistently adhere to the high standards necessary to support work performed in compliance with the Good Laboratory Practice (GLP) guidelines. While some suppliers provide products manufactured utilizing Good Manufacturing Practices (GMP) and...
The Regulation of Pharmaceutical Excipients
Pharmaceutical excipients are vital components of drug formulations and are generally considered pharmacologically inert. Control of excipient manufacturing and distribution is now considered a key priority by regulatory authorities and pharmaceutical manufacturers, because adulteration of pharmaceutical excipients has resulted in adverse effects in patients. Furthermore, with the emergence of novel excipients and delivery systems, better quality and supply control of pharmaceutical excipients becomes increasingly important in the context of in vivo performance. Recognizing the critical role that excipients play in pharmaceutical dosage forms necessitates that excipient suppliers meet the quality requirements of the pharmaceutical industry and the pharmaceutical industry as a whole must work to assume integrity of the supply chain