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WHO Expert Committee on Specifications for Pharmaceutical Preparations
WHO Expert Committee on Specifications for Pharmaceutical PreparationsWorld Health Organization
其他書名
Forty-eighth Report
出版World Health Organization, 2014
主題Business & Economics / Industries / Pharmaceutical & BiotechnologyMedical / PharmacologyMedical / PharmacyMedical / Public Health
ISBN92412098609789241209861
URLhttp://books.google.com.hk/books?id=x68XDAAAQBAJ&hl=&source=gbs_api
EBookSAMPLE
註釋The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process.

The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.