Articles by Dale Carter - Pharmaceutical Technology

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Articles by Dale Carter

Dale Carter


Dale Carter is manager of product quality and management systems, Office of Compliance and Ethics, at Archer Daniels Midland Company (Decatur, IL).

Articles
Standardized Excipient GMP
March 1, 2012

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

Risk Assessment for Excipients for Enhanced Patient Safety
April 1, 2011

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area.

Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies
September 2, 2007

This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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