GMP for APIs and Vendor Qualification - Institute of Validation PDF
800 Pages·2013·19.3 MB·English
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Preview GMP for APIs and Vendor Qualification - Institute of Validation
Benchmarking: The role of Inspection Findings and Global Trends in cGMP Compliance For: IVT’s GMP Week San Diego, June 2012 Do you know what’s going on? Legislation updates • 2010/84/EU –Pharmacovigilance Directive – To be implemented in all Member States: July 2012 – Quality System for performance of PV – PV System Master File (PSMF) • 2011/62/EU – Falsified Medicines Directive – Will affect import of APIs from third countries – Requires unique identifiers on packs (2017) EU GMPs EU GMPs EU GMPs – Annexes Under Revision GDP Draft (from 4 – 32 pages) 7 GDP Draft - TOC 8 GDP Draft - TOC 9 GDP Draft - TOC 10
Description:GMP guide . 1 batch record did not contain a representative stick-on box label.
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