Transcription of GUIDELINE ON SPECIFICATONS: TEST PROCEDURES AND …
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GUIDELINE ON SPECIFICATONS: TEST PROCEDURES AND …
European Medicines Agency Inspections London, 30 March 2006. CPMP/QWP/2820/00 Rev 1. EMEA/CVMP/815/00 Rev 1. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR. MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP). GUIDELINE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR HERBAL SUBSTANCES1, HERBAL PREPARATIONS2 AND HERBAL MEDICINAL PRODUCTS3/TRADITIONAL. HERBAL MEDICINAL PRODUCTS. DISCUSSION AT THE HMPC January March 2005. DRAFT AGREED BY QUALITY WORKING PARTY April 2005. ADOPTION BY CHMP FOR RELEASE FOR 26 May 2005. CONSULTATION. ADOPTION BY CVMP FOR RELEASE FOR 15 June 2005.
compounds suitable as active markers or analytical markers. Includes chromatographic fingerprinting. 2.1.3. Impurities Impurities can be classified as follows: - impurities arising from starting materials (active substances, excipients) and containers; - process related impurities arising from the manufacturing process.
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