BioPharm International-06-01-2019

BioPharm International

FDA Advances New Approach to Drug Quality Assessment

June 02, 2019

Regulatory Beat

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CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

Bio/Pharma Facilities Still Have a Lot to Learn

June 01, 2019

From the Editor

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FDA’s annual manufacturing report card shows more quality compliance is needed.

Quality Agreements and Out-of-Specification Investigations

June 01, 2019

Ask the Expert

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A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Pipeline Expression Platforms and the Future of Upstream Processing

June 01, 2019

Features

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BioPharm International speaks with several experts to learn more about pipeline platforms and technologies.

BioPharm International, June 2019 Issue (PDF)

June 01, 2019

Issue PDF

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Click the title above to open the BioPharm International June 2019 issue in an interactive PDF format.

From Data to Information

June 01, 2019

Features

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Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.

GLPs: Better Data Access Needed to Improve Compliance

June 01, 2019

Features

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Stuart Jones, regulatory quality assurance professional in good laboratory practice (RQAP-GLP) and director of quality assurance at PPD Laboratories’ Bioanalytical Laboratory shared GLP best practices with BioPharm International.