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PharmTech.com Quality and Regulatory Sourcebook March eBook 2023 Pharmaceutical Technology ® 29 Manufacturing for Human D r ug Compounding O utsourcing Facili- ties Under Section 503B of the FD&C Act, Insanitar y Condit ion s at Compounding Facilit ies, a nd Ste r ile D r u g P r o du c t s P r o du ce d b y A s e pt i c P r o ces s in g — Cur rent G ood Manufact ur ing P ract ice. Reg u lator y Compliance Associates, Inc. also recommend com- pounders review the Parenteral Drug Association's Technical Report #62 titled Recommended Practices for Manual Aseptic Processes. PharmTech: What do dr ug compounders of ten fai l to do when ensuring qua lit y of compounded medicines? Schniepp/Lynn (RCA): Many compounders fail to perform the necessar y steps to ensure the prod- uct quality. This includes inadequate smoke studies, poor aseptic technique, inadequate environmental monitoring program, inadequate equipment clean- ing program, and poor gowning techniques. The aseptic guidelines for compounders developed by FDA addresses these areas of concern. Regulator y Compliance Associates, Inc. recommend that com- pounders explore the FDA warning letters to deter- mine what the regulators are concerned with and utilize that information to continuously improve their operations. PharmTech: W hat a re some best prac t ices for drug compounding? Schniepp/Lynn (RCA): Est abl i sh i ng a st rong qualit y culture is critical to adhering to best prac- t ices. I f t he compou nders have a st rong qua l it y cu lt ure a nd fol low t he FDA g uidelines a nd reg u- lations, they will be following best practices and should have no problem with FDA inspections. Reg- ulator y Compliance Associates, Inc. suggest orga- nizations investigate the FDA's website and look at Compounding Quality Center of Excellence website where there is a plethora of information and free on-line training that will help compounders ensure they are meeting the regulations and producing safe and effective product. Reference 1. FDA. Human Dr ug Compounding. FDA .gov. (ac- cessed Jan. 10, 2023). ■ for compounding nonsterile and sterile medicines. USP compounding General Chapters establish procedures and methods for practitioners to use to consistently produce quality compounded preparations, which in turn helps to protect patient safety. Some specific updates to chapter <795> include recommendations and requirements for facilities and equipment, minimum frequencies for cleaning, and more information about the protective garb that personnel wear. Among the changes to chapter <797>, there are updates to requirements for facility design, frequency and type of environmental monitoring, personnel training, and competency evaluation. The updated chapters also include a scientifically robust and risk-based approach to assign beyond-use dates (BUDs)—the date after which a compounded preparation must not be used—for compounded medicines. This approach allows for longer beyond-use dates under certain circumstances, while still aiming to help protect patients from changes to a compounded medicine that may occur over time. PharmTech: What do drug compounders often fail to do when ensuring quality of compounded medicines? Serumaga (USP): In some circumstances, poor quality compounded medicines have led to critical patient safety concerns. Adhering to the standards helps to protect patient health. The recently revised chapters <795> and <797> include some updates that provide clarity on several topics to help ensure the quality of compounded medicines, such as those related to maintaining a sterile environment, establishing tests to assess stability and storage conditions, and procedures to verify the identity, strength, quality, and purity of components and finished compounded drugs. —Susan Haigney USP Standards in Drug Compounding (Cont.) A 24-hour streaming program Streaming now! www.medicalworldnews.com For Health Care Professionals, By Health Care Professionals powered by