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.
Congress Probes FDA's Inspection Process of Actavis
October 15th 2008John Dingell (D-MI), chairman of the US House Committee on Energy and Commerce and Bart Stupak (D-MI), chairman of that committee's Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA's process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company.
EFCG and IPEC Europe Establish an Excipient Certification Project
October 9th 2008The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipents Council of Europe (IPEC Europe) announced the formation of a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe and to give advice to two European working teams as part of an effort to develop a certification program for manufacturers and distributors of pharmaceutical excipients.
REACH's Impact on the Pharmaceutical Industry
October 8th 2008The pharmaceutical industry faces compliance with the REACH regulation, the European Union's regulation on chemicals and their safe use. Fully understanding the requirements, achieving compliance, and developing strategies for working with suppliers are key for avoiding interruption of the supply chain.
Risk Management within the Global Supply Chain
October 1st 2008The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.