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DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC ...

DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC ...

www.who.int

Working 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

  Development, Pharmaceutical, For pharmaceutical, Generic, Multisource, Pharmaceutical development for multisource

Annex 1 WHO good practices for pharmaceutical quality ...

Annex 1 WHO good practices for pharmaceutical quality ...

www.who.int

82 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.

  Good practices for pharmaceutical, Good, Practices, Pharmaceutical, For pharmaceutical, Good practices

232 ELEMENTAL IMPURITIES—LIMITS

232 ELEMENTAL IMPURITIES—LIMITS

www.usp.org

for 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.

  Pharmaceutical, For pharmaceutical, Excipients

Guidance for Industry - Food and Drug Administration

Guidance for Industry - Food and Drug Administration

www.fda.gov

Guidance for Industry . M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

  Administration, Pharmaceutical, Drug, For pharmaceutical, Guidance, Food and drug administration, Food, Human, Industry, Guidance for industry

WHO Expert Committee on Specifications for …

WHO Expert Committee on Specifications for

www.who.int

WHO Expert Committee on Specifications for Pharmaceutical Preparations The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical

  Pharmaceutical, Specification, For pharmaceutical, Committees, Expert, Who expert committee on specifications for, Expert committee, Expert committee on specifications for pharmaceutical

GOOD DISTRIBUTION PRACTICES (GDP) FOR …

GOOD DISTRIBUTION PRACTICES (GDP) FOR

www.who.int

Working 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

  Good, Practices, Pharmaceutical, For pharmaceutical, Distribution, Good distribution practices

Substances for Pharmaceutical Use 2034E - uspbpep.com

Substances for Pharmaceutical Use 2034E - uspbpep.com

www.uspbpep.com

excipients. 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.

  Pharmaceutical, For pharmaceutical, Excipients, Of excipients

GOOD MANUFACTURING PRACTICES FOR …

GOOD MANUFACTURING PRACTICES FOR

www.who.int

working 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

  Guidelines, Pharmaceutical, Manufacturing, For pharmaceutical

Annex 9 Guidelines on packaging for pharmaceutical …

Annex 9 Guidelines on packaging for pharmaceutical

apps.who.int

122 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

  Guidelines, Pharmaceutical, For pharmaceutical, Packaging, Guidelines on packaging for pharmaceutical

WHO GOOD MANUFACTURING PRACTICES: …

WHO GOOD MANUFACTURING PRACTICES:

www.who.int

Working 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

  Practices, Pharmaceutical, Manufacturing, For pharmaceutical, Guidance, Manufacturing practices

GOOD MANUFACTURING PRACTICES FOR …

GOOD MANUFACTURING PRACTICES FOR

www.who.int

working 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

  Guidelines, Practices, Pharmaceutical, Manufacturing, For pharmaceutical, Manufacturing practices for

SCHEDULE M GOOD MANUFACTURING PRACTICES AND …

SCHEDULE M GOOD MANUFACTURING PRACTICES AND

www.rajswasthya.nic.in

schedule 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)]

  Good, Practices, Pharmaceutical, Requirements, Manufacturing, For pharmaceutical, Good manufacturing practices and requirements of, Good manufacturing practices and

SCHEDULE M - Central Drugs Standard Control Organization

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

  Practices, Pharmaceutical, Schedule m, Schedule, For pharmaceutical

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