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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

Warning letters issued by FDA can be an important source of data to study and analyse violations that occur in pharmaceutical manufacturing. Such studies can also help companies prepare for their upcoming inspections by enabling them to identify and rectify any issues.

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WuXi STA breaks ground on new Delaware manufacturing facility

European Pharmaceutical Review

Contract research, development and manufacturing organisation (CRDMO) WuXi STA has broken ground on its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware, US. The biopharmaceutical industry is part of Delaware’s DNA,” stated Delaware Governor John Carney.

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PHARMAP 2024 held in Amsterdam, marks its fourth edition

Express Pharma

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. Among the attendees, contract manufacturing organisations, service providers and experts were present.

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Steriline to exhibit its Robotic Vial Filling Machine at ACHEMA 2024

Express Pharma

The market for pharmaceutical packaging will grow by 8.24 per cent worldwide and the market for pharmaceutical packaging machines by 7.5 per cent per year until 2028 1. in the EU).

Packaging 101
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Rapid pseudomonas aeruginosa detection method developed

European Pharmaceutical Review

The study used medications labelled as “sterile, oral and topical preparations, components of formulations for micro-pellicle media, re-agents, and chemical compounds for achieving selectivity, factors promoting multiplication, and inhibition factors.” aeruginosa bacteria in pure culture, mixed culture, or other research materials.

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At Agilent, we believe that sustainability, productivity and efficiency can co-exist in a lab without compromising on ROI

Express Pharma

This partnership started with select Agilent instruments being independently audited for the organisation’s Accountability, Consistency, and Transparency (ACT) Environmental Impact Factor Label. Initially, we began by partnering with My Green Lab on the organisation’s ACT Environmental Impact Factor Label programme.

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FDA releases analysis on drug product quality in 2022

European Pharmaceutical Review

Therefore CDER stressed the need to maintain labelled storage conditions and monitor those conditions throughout the drug supply chain. Reflecting on five years of quality control for nitrosamine impurities Warning Letters In FY2022, the FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites.