Within the pharmaceutical sector, ensuring the safety and effectiveness of drugs stands as an utmost priority. A mounting concern within this industry revolves around the integrity of container closures. These closures hold a pivotal responsibility in safeguarding the sterility of drugs and preventing any undesired alterations during their entire lifecycle.
Major regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are placing increasing emphasis on the proper design and conduct of Container Closure Integrity Testing to ensure the safety and efficacy of pharmaceutical products.
In 2016, the U.S. Pharmacopeia introduced a new guideline called USP <1207>, which provides basic instructions related to leak rate and sealing/closing mechanisms of packages, focusing on sterile and critical pharmaceutical products, such as vials and syringes.
August 2022 also saw the release of the new version of Annex 1 of the EU GMP, specifically dedicated to the manufacture of sterile medicinal products. The regulations came into effect a few days ago (August 25th 2023), with the exception of Section 8.123 on lyophilization, which will come into effect on August 25th 2024.
Container Closure Control therefore assumes a critically important role as a routine procedure for the release of product batches. Proper implementation of such practices will not only help preserve container integrity, but also ensure that the highest standards of quality and safety are maintained.
LabAnalysis provides years of experience and state of the art instrumentation to provide the Client with comprehensive support in the proper validation of Container Closure Integrity Testing.
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