2024, Method Validation and Packaging

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2024

Method Validation

Packaging

FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

DECEMBER 23, 2024

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.

Documentation

Documentation Method Validation Pharmaceutical Manufacturing Packaging

FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

JANUARY 25, 2024

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.

Documentation

Documentation Method Validation Packaging Labelling

Pharmacist Digest

FOPE and PharmaState Academy hosts Session 11 of the PULSE series

FDA guidance highlights E&L considerations for ophthalmic drug products

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