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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.

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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

He also discussed the importance of having retention samples for raw materials and packaging materials and the role of quality control in investigating deviations and ensuring the stability of raw materials. He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing. Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots.

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How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging

European Pharmaceutical Review

Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.

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Leading commercial packaging companies in contract marketing

Pharmaceutical Technology

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility.