F.A.Q’s Current Regulatory Requirements for Aseptically Produced Products
July 13, 2018 - Online Event ON CAWebinar Compliance
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The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents that address other issues such as closure integrity and sterility test methods that were recently revised in 2012. Today, the regulatory requirements for sterile products are found in a “Guidance for Industry” document that was published in 2004. In addition, there are requirements found in 21 CFR 210-211 and 820. In all of these documents, the areas of importance and audit focus are: Equipment, utility and facility qualifications Validation of all sterilization processes Control of the environment and potential sources of contamination Personnel training and gowning requirements based on defined areas of cleanliness Laboratory controls and Process simulations designed to verify the acceptability of the manufacturing process and operator activities.