Ingredients
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August 8th 2024
Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.
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European Fine Chemicals Group Issues Assessment Tool to Promote Supply-Chain Security
June 25th 2009Following the 2008 launch of the European Fine Chemicals Group (EFCG) Voluntary Guidelines (VGs) to promote supply-chain security, the group has now announced the official launch of an assessment template that will allow fine chemicals customers and suppliers to assess and implement this new set of recommendations.
FTC Report on Follow-on Biologics Sparks Congressional Debate
June 18th 2009The Subcommittee on Health of the US House of Representatives Energy and Commerce Committee held hearings last week to discuss the findings of a report by the Federal Trade Commission (FTC) that examined the competitive effects for follow-on-biologics (FOBs).
European Commission Won't Pursue Directive for Excipient GMPs
June 11th 2009The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.
House Introduces Discussion Draft for Drug and Food Safety
June 4th 2009Members of the House Committee on Energy and Commerce, Chair Emeritus John D. Dingell (D-MI), Chair Henry A. Waxman (D-CA), and Reps. Frank Pallone (D-NJ), Bart Stupak (D-MI), Diana DeGette (D-CO) and Betty Sutton (D-OH) released last week a discussion draft of the Food Safety Enhancement Act of 2009.
