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Manufacturing

Set Alert for Manufacturing

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
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Latest From Manufacturing

Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded

Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.

FDA Legal Issues

FDA Aims For Greater Role In Pharma Business Continuity Planning

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Manufacturing Quality

FDA Inspectors Focusing Attention On Traditional Manual Aseptic Filling Lines

Firms that manufacture sterile drugs on traditional filling lines instead of using restricted access barriers or isolators risk tighter scrutiny from FDA inspectors, agency official says. Yet it remains unclear how much of a difference the increased oversight will make.

 

Manufacturing Quality

Proponents Of Quality Control Multi-Attribute Methods Tackle Adoption Challenges

Challenges ranging from fear of QC job loss to training requirements and discovery of surprise impurities confront effort to expand the use of powerful test methods for release of biopharmaceuticals.

Quality Manufacturing

The Quality Lowdown: Valsartan Options, Supply Chain Warnings, Button Cameras

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

Manufacturing Quality

Generics Firms Improved Chances Of Winning Pre-ANDA Meetings For Complex Drugs Last Year

FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.

Manufacturing Quality
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