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Manufacturing

Set Alert for Manufacturing

Early GMP Compliance Seen As A Key To Avoiding Complete Responses

Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.

Manufacturing Quality Clinical Trials

Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say

Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.

Manufacturing Quality United States

Latest From Manufacturing

FDA’s OPQ Chief Tells Generic Drug Makers Its Time To Up Their Quality Game

The head of US FDA’s drug quality office comments on quality-related topics at the GRx-Biosims meeting; sheds more light on facility rating system plan.

Manufacturing Quality

First-Ever OTC Inspections Drove Surge Of FDA Warning Letters In FY 2019

The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.

Manufacturing Quality

US FDA Finds Zantac Poses Little Risk, But Concerns Linger

Ranitidine no more carcinogenic than grilled meat, the FDA’s Woodcock says, with NDMA levels well below those claimed by Valisure.

Manufacturing Quality

Drug Makers Have Exceeded Expectations In Implementing DSCSA Serialization

A new barcode assessment study finds the US pharmaceutical industry has come a long way in serializing drug products over the past several years. 

Manufacturing Quality

Real-Time Manufacturing Volume Reporting Could Help Prevent Drug Shortages, Woodcock Tells Congress

If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.

Quality Manufacturing

EU Offers Practical Guide To Help Pharma With Nitrosamine Evaluations

The EU guide covers medicines authorized at the national level and under the mutual recognition and decentralized procedures.

Manufacturing Regulation
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