A WHO guide to good manufacturing practice (GMP) requirements, part 1: standard operating procedures and master formulae
It provides a framework to aid vaccinemanufacturers to assess their planned or existing documents describing the methodsused to produce and test, and administratively control the manufacture of a vacc...
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Resource added in:
17/05/2001
Available languages:
Spanish, English
Vaccines, Chemistry, Pharmaceutical/methods, Reference Books, Guia [tipo de publicação]
A WHO guide to good manufacturing practice (GMP) requirements, part 2: validation
It presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytica...
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Resource added in:
17/05/2001
Available languages:
English, Spanish
Vaccines, Quality Control, Chemistry, Pharmaceutical/methods, Reference Books, Guia [tipo de publicação], production of of substances, products and materials
Guide for inspection of manufacturers of biological products
It presents requirements for good manufacturing practices (GMP), in a form which can be used for determining whether a manufacturer complies with the GMP recommendations, as well as serving as an aid ...
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Resource added in:
17/05/2001
Available languages:
English, Spanish
Vaccines, Chemistry, Pharmaceutical, Biological Products, Quality Control, Reference Books, Guia [tipo de publicação], Vacinas e imunização, produção de substãncias, productos e materiais
Guide for a quality systems manual in a control laboratory
This guide seeks to establish a practical basis for the Quality Systems Manual of a control laboratory which each country can then adopt in order to prepare its own more detailed manual according to t...
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Resource added in:
17/05/2001
Available languages:
English, Spanish
Vaccines, Quality Control, Guidelines as Topic, Chemistry, Pharmaceutical, Reference Books, Guia [tipo de publicação]
Ensuring the quality of locally produced vaccines and the viability of local production
It presents control functions and strategies which may assure the quality of vaccines supplied through local production. A version in Russian is available. Document in pdf format; Acrobat Reader requi...
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Resource added in:
17/05/2001
Available languages:
English, Spanish, French
Vaccines, Quality Control, vacinas e imunização
Options for a global fund for new vaccines
It discusses five parameters of such a fund: equity, impact, feasibility, sustainability and scope. For each, goals such as access, effectiveness, and independence are discussed, including an analysis...
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Resource added in:
16/05/2001
Available languages:
English
Vaccines/economics, Fund Raising
User fees for immunization in developing countries
It discusses the negative aspects of the implementation of user fees for immunization and vaccination. Document in pdf format; Acrobat Reader required.
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Resource added in:
16/05/2001
Available languages:
English
Vaccination/economics, Fees and Charges
Practice and policies on user fees for immunization in developing countries
This paper consists of a review of international organization policy on user feesfor immunization, a short annotated bibliography of relevant literature, and acompilation of examples of the implementa...
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Resource added in:
16/05/2001
Available languages:
English
Vaccination/economics, Immunization/economics, Fees and Charges
Strengthening national regulatory authorities (NRAs)
It presents six critical control functions which must be exercised by countries producing vaccines for ensuring that products released for public distribution are evaluated properly and meet internati...
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Resource added in:
16/05/2001
Available languages:
English
Vaccines/standards, Quality Control, Vacinas e imunização
Regulation of vaccines: building on existing drug regulatory authorities
It presents information on the principles and procedures applying to the regulation, control, and standardization of vaccines, drug regulatory authority functions, features of a regulatory system for ...
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Resource added in:
16/05/2001
Available languages:
English
Vaccines/standards, Quality Control, Health Surveillance, Reference Books, Vacinas e imunização, ]cação]cação]cação]cação], Produtos biológicos, hemoterápicos
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