Search results with tag "For pharmaceutical"
DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC ...
www.who.intWorking document QAS/08.251 January 2008 RESTRICTED DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS This draft is based on the concept paper QSM/EC/07.29 “Guideline for pharmaceutical
Annex 1 WHO good practices for pharmaceutical quality ...
www.who.int82 General considerations The WHO Expert Committee on Specifi cations for Pharmaceutical Products adopted in 1999 the guidelines entitled WHO Good practices for national pharmaceutical control laboratories, which were published as Annex 3 of the WHO Technical Report Series, No. 902, 2002.
232 ELEMENTAL IMPURITIES—LIMITS
www.usp.orgfor pharmaceuticals. Thus, the limit was established assuming the most common (mercuric) inorganic form. Limits for articles ... The concentration of elemental impurities in drug substances and excipients must be controlled and, where present, docu-mented. The acceptable levels for these impurities depend on the material's ultimate use.
Guidance for Industry - Food and Drug Administration
www.fda.govGuidance for Industry . M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
WHO Expert Committee on Specifications for …
www.who.intWHO Expert Committee on Specifications for Pharmaceutical Preparations The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical
GOOD DISTRIBUTION PRACTICES (GDP) FOR …
www.who.intWorking document QAS/04.068/Rev.2 page 2 SCHEDULE FOR THE ADOPTION PROCESS OF DOCUMENT QAS/04.068/REV.2: GOOD DISTRIBUTION PRACTICES (GDP) FOR PHARMACEUTICAL PRODUCTS Deadline First draft prepared and mailed for comments January 2004
Substances for Pharmaceutical Use 2034E - uspbpep.com
www.uspbpep.comexcipients. Solid substances may be compacted, coated, granulated, powdered to a certain fineness or processed in other ways. Processing with addition of excipients is permitted only where this is specifically stated in the Definition of the individual monograph. Substance for pharmaceutical use of special grade.
GOOD MANUFACTURING PRACTICES FOR …
www.who.intworking document qas/08.256 rev.1 page 2 schedule for the proposed adoption process of document qas/08.256: guideline on good manufacturing practices for pharmaceutical
Annex 9 Guidelines on packaging for pharmaceutical …
apps.who.int122 General bulk product Any product that has completed all the processing stages up to, but not including, final packaging (1).containers A container for pharmaceutical …
WHO GOOD MANUFACTURING PRACTICES: …
www.who.intWorking document QAS/10.379 page 4 1. Introduction 1.1 Scope of the document The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical
GOOD MANUFACTURING PRACTICES FOR …
www.who.intworking document qas/08.256 rev.1 page 2 schedule for the proposed adoption process of document qas/08.256: guideline on good manufacturing practices for pharmaceutical
SCHEDULE M GOOD MANUFACTURING PRACTICES AND …
www.rajswasthya.nic.inschedule m good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products gazette of india extraordinary, part ii-section 3, sub-section (i)]
SCHEDULE M - Central Drugs Standard Control Organization
www.cdsco.nic.in[SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. Note: - To achieve the objectives listed below, each licensee shall evolve appropriate
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