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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

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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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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Technical deviation : These can be raised for validation discrepancies, i.e., manufacturing instruction modification.

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How to use quality risk management in validation testing

GMPSOP

Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Risk management scope definition The purpose or objective of the application of risk management needs to be clearly understood. Subscribe Step 1. Is this used to distribute the product?

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips.

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How to test, adjust and balance HVAC systems

GMPSOP

Subscribe Some useful definitions of HVAC systems maintenance HVAC: Heating, ventilation and air conditioning is the use of various technologies to control the temperature, humidity and purity of the air in an enclosed space. Additional documents included each month. All written and updated by GMP experts. Checkout sample preview s.