Transcription of Template for the Qualified Person’s Declaration …
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Template for the Qualified Person’s Declaration …
7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7<XXX XXXX> E-mail Website An agency of the European Union European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged. 1 2 3 4 5 6 7 8 16 December 2010 EMA/CHMP/CVMP/QWP/696270/2010 Template for the Qualified Person s Declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain The QP Declaration Template Draft Draft Agreed by QWP September 2010 Adoption by CVMP for release for consultation 9 December 2010 Adoption by CHMP for release for consultation 16 December 2010 End of consultation (deadline for comments) 30 Sept 2011 9 10 Comments should be provided using this Template . The completed comments form should be sent to 11 Keywords Qualified Person; Active Substance; Starting Material; good Manufacturing Practise; Supply Chain Template FOR THE Qualified PERSON S Declaration 12 CONCERNING GMP COMPLIANCE OF THE ACTIVE SUBSTANCE 13 USED AS STARTING MATERIAL AND VERIFICATION OF ITS 14 SUPPLY CHAIN The QP Declaration Template 15 16 17 18 19 20 21 22 23 25 27 28 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 1.
The attached QP declaration template provides, in a format considered suitable for submission, a basis for demonstrating compliance of the active substance manufacture with GMP requirements and that
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