This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
News|Articles|April 5, 2007
EC Plans Directive on GMPs for Excipients
Author(s)Pharmaceutical Technology Editors
Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.
Advertisement
Brussels, Belgium (Mar. 22)-The European Commission’s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium,
DG Enterprise and Industry will share the results of the questionnaire with Europe Economics (London, UK,
A draft entitled “Specific Conditions of the Application of the Principles and Guidelines of GMP for Certain Excipients” is planned for publication as a possible basis for the GMP directive.
The questionnaire should be completed by July 30, 2007 and can be accessed by visiting
Advertisement
Related to this article
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
Advertisement
Advertisement