Articles by Susan Haigney - BioPharm International

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Articles by Susan Haigney

Implementing QbD in Sterile Manufacturing

To gain perspective on the implementation of quality by design (QbD) in sterile manufacturing, BioPharm International spoke with Wolfgang Weikmann, vice-president quality assurance at Vetter Pharma-Fertigung GmbH & Co.KG.
Dec 1, 2013

Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.

Challenges in Managing the Cold Chain

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.
Nov 1, 2013

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

QbD and PAT in Upstream and Downstream Processing

BioPharm International talks to industry experts about the implementation of QbD and PAT tools in biopharmaceutical manufacturing
Jul 1, 2013

Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.

Compounding Pharmacies Recall Products

Apr 16, 2013

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

FDA Commissioner Claims Resistance to Compounding Pharmacy Inspections

Apr 12, 2013

FDA inspections of compounding pharmacies result in FDA-483 citations.

FDA Requests Almost $5 Billion for 2014 Budget

Apr 12, 2013

FDA's FY 2014 budget includes more than $10 million above the 2012 budget for inspections of products and ingredients manufactured in China.

The Lifecycle Change of Process Validation and Analytical Testing

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.
Mar 1, 2013

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

USP Changes Heparin Labeling Requirement

Nov 5, 2012

USP revises labeling requirements for Heparin.

CDER to Expand Office of Generic Drugs

Sep 11, 2012

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

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