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On December 15, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 11 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Good Practices In Quality Control. Chaudhary explained the necessity of sampling excipients and the exemption for dedicated facilities.
Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.
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