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New guidance for Manufacturing Specials developed by MHRA

By: Pharma News | Views: 2202 | Date: 11-Nov-2013

The UK health regulator, MHRA has developed a new guidance document for Manufacturing Specials (MS). This document mainly aims at ensuring consistency during routine inspections for checking the standards of Good Manufacturing Practice (GMP). It will also ascertain that MS license holders are aware of the standard expectations and hence this draft guidance is important


New guidance for Manufacturing Specials developed by MHRA

The UK health regulator, MHRA has developed a new guidance document for Manufacturing Specials (MS). This document mainly aims at ensuring consistency during routine inspections for checking the standards of Good Manufacturing Practice (GMP). It will also ascertain that MS license holders are aware of the standard expectations and hence this draft guidance is important.



The draft guidance for Manufacturing Specials has been developed as a result of questions raised over Specials in the last few years. While it aims at maintaining consistency of GMP inspections and overall standards, it is equally important to maintain quality standards. This guidance will be planned as a living document and would be updated as per the requirement. The MS license holders would be given a period of 6 months to familiarize with this document. They are then expected to implement any related that are required to make changes to their operating and quality systems till the given period up to 1st April 2014.

This step aims at building a safe animal and pet food system with risk based preventive control that regulate the entire system. The domestic and foreign facilities that manufacture animal food need to register under the Federal Food, Drug, and Cosmetic Act for the same. The proposed rule welcomes electronic or written comments that would help the whole process.
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