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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
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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

Risk-Based Approach To Protecting Data Integrity Outlined In Forthcoming PDA Report

An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.

Manufacturing Quality

US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

Quality Enforcement

FDA Warns Glenmark Over Temperature Excursions, Gritty Topicals

Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.

United States Manufacturing

Quality Advice On How To Surf The Approaching Wave of Cell And Gene Therapies

Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.

Quality Manufacturing

Nitrosamine Episode Could Lead To Paradigm Shift In Quality

The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.

Manufacturing Regulation

PDA, ISPE Launch Quality Culture Effort With Root Cause Analysis Guide

Industry groups PDA and ISPE have banded together to produce a guide to help pharmaceutical manufacturers get a better handle on their deviations through choosing the right root cause analysis method and human factors studies.

United States Manufacturing
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