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Manufacturing

Set Alert for Manufacturing

US FDA Budget Boost Would Increase Domestic Drug Manufacturing By Better Regulating New Technologies

FDA’s fiscal year 2020 budget request calls for spending on figuring out how to regulate new drug manufacturing technologies under the rubric of increasing US domestic manufacturing.

Quality Compliance Manufacturing
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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

ICH To Partner For Training Of Regulators, Industry On Key Guidelines

The organization that works to harmonize drug review requirements across a growing number of regulatory authorities aims to partner with non-profit groups to train regulatory authorities and industry on its guidelines, starting with guidelines on stability testing, good clinical practice and good manufacturing practices for active pharmaceutical ingredients.

Manufacturing Quality

Pharmakon CEO Convicted Over Life-Threatening Potency Failures

Jury convicts Pharmakon CEO of conspiracy to defraud the FDA and nine counts of adulterating drugs. The firm allegedly ignored and tried to cover up dangerously out-of-specification potency testing results for morphine and other compounded drugs. In one case, providers resorted to naloxone to rescue an overdosed infant.

 

Manufacturing Quality

The Quality Lowdown: Foreign Burden, Border Destruction, Particles, Sterility

FDA asks about regulating foreign firms more and destroying drugs at the border, and questions firms about particles and aseptic practices.

Manufacturing Quality

FDA Testing Data Exchange Standards For Drug Specifications Under PQ/CMC Pilot

FDA announces the rollout of a pilot program with industry to exchange data on quality specifications for the Common Technical Document’s Module 3. The agency plans to exchange data on other portions of the CTD’s quality section later this year. The data exchange would largely replace the “hunting and pecking” for information in PDFs that reviewers have to do to locate quality information in NDAs and ANDAs.

Manufacturing Quality

Lack Of Harmonization In ICH Q12 Draft Guideline Draws Fire In US

Major pharmaceutical industry groups in the US, like their counterparts in the EU, are concerned that the draft ICH Q12 guideline does not align with the established legal framework in certain ICH regions, including the EU, in terms of implementing key concepts such as established conditions and product lifecycle management.

Manufacturing Quality

How FDA Says Its KASA Plan Will Streamline Quality Reviews

FDA officials described some of the work being done to advance its KASA initiative, under development to make it easier for reviewers to evaluate, and for applicants to submit, quality information in applications. They compared KASA, with its pre-populated data and drop-down menus, to tax return software.

 

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