- Published: Wednesday February 24 2016 09: 50
This Implementation Working Group (IWG) Was endorsed by the ICH Steering Committee in October 2014. Throughout the development of the Guideline Q3D, external audiences, constituents and interested parts-have Clearly Communicated the complexity of the implementation Approaches for this guideline.
- Published: Wednesday January 20 2016 09: 50
This Best Practices Guide Quality Agreement is Intended to assist Both Customers and Suppliers Efficiently managing in the initiation, negotiation, implementation, and Ongoing Maintenance of quality agreements. Generally, entre Such agreements are drug manufacturers and Their material and the service providers (ie manufacturers of APIs, excipients, packaging materials, etc. as well as provider of GxP services, analytical or --other services to drug manufacturers.
- Published: Wednesday January 6 2016 17: 50
"This section contains Proposals for adoption as official USP or NF standards (Either Proposed Proposed new standards or revisions of current USP or NF standards). These May be'any of the Following: (1) Proposed revisions Placed Directly under In-Process Revision, gold (2) modifications of Previously Proposed revisions under In-Process Revision. Readers shoulds review material in this section and Provide comments to the Scientific Liaison using the contact details Appearing at the end of Each proposal. Information on how to comment can be found under the "Participation" section of www.usp.org. It is significant to send comments aussitôt, using the comment deadline listed after-Each title "
- Published: Wednesday January 20 2016 08: 50
This guidance Describes our current thinking there Defining, Establishing, and Documenting the Responsibilities of Each party (or all parts) Involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).
- Published: Thursday December 24 2015 08: 50
These guidelines are based on Article 47 fourth paragraph of Directive 2001 / 83 / EC of the European Parliament and of Conseil1. They follow the principles on which the guidelines are also based on the volume of 4 EudraLex, Part II, Chapter 17, regarding the distribution of active substances and the guidelines of November 5 2013 on good distribution practices wholesale medicines for human use.