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Medicines that have a very short shelf life may require alternative testing strategies for product release. For example, the 14 day growth-based sterility test may not be appropriate for drug products that need to be administered to the patient prior to obtaining the final sterility test result. Products that are most impacted by this challenge include gene and cell therapy or advanced therapy medicinal products (ATMP), positron emission tomographic (PET) drugs and compounded sterile preparations (CSP) prod
Fortunately, regulators and compendia have recommended alternative strategies for the testing and release of these types of drug products.
Each of the references discussed below may be downloaded from our References Page .