E-DRUG: New WHO quality standards and guidelines for public consultation
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Dear E-druggers
The WHO website has a full load of new standards and guidelines up for
comments: medical devices framework, QC labs, GMP, pre-qualification, etc etc
Go to the WHO website
http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/
and download:
WHO global model regulatory framework for medical devices including IVDs
(QAS/16.664)
pdf, 1.94Mb
Prequalification of quality control laboratories. Procedure for
assessing the acceptability, in principle, of quality control laboratories
for use by UN agencies (QAS/16.656)
pdf, 399kb
Supplementary guidelines on good manufacturing practices for heating,
ventilation and air-conditioning systems for non-sterile pharmaceutical
dosage forms (QAS/15.639/Rev.1)
pdf, 3.38Mb
Collaborative procedure between the World Health Organization (WHO)
Prequalification Team-Medicines and national medicines regulatory
authorities in the assessment and accelerated national registration of
WHO-prequalified pharmaceutical products1 and vaccines (QAS/15.633)
pdf, 713kb
Guidelines on the conduct of surveys of the quality of medicines
(QAS/15.630)
pdf, 753kb
Guidance on good manufacturing practices: Inspection report (QAS/15.625)
pdf, 284kb
Appendix 1 to WHO working document (QAS/15.625)
pdf, 85kb
Guidance on good data management practices (QAS/15.624)
pdf, 946kb
WHO certification scheme on the quality of pharmaceutical products
moving in international commerce: Q&A (QAS/15.623)
pdf, 519kb
Proposal for revision
Guidance for organizations performing in vivo bioequivalence studies.
Proposal for revision (QAS/15.622/Rev1))
pdf, 819kb
Proposal for revision of good trade and distribution practices for
pharmaceutical starting materials (QAS/15.611)
pdf, 323kb
Recommendations on the content of a survey protocol for surveys of the
quality of medicines (QAS/14.590)
pdf, 2.72Mb
WHO general guidance on variations to multisource pharmaceutical
products (QAS/14.575/Rev.1)
pdf, 397kb
Good pharmacopoeial practices (QAS/13.526/Rev.6)
pdf, 685kb
FIP-WHO technical guidelines: points to consider in the provision by
health-care professionals of children-specific preparations that are not
available as authorized products (QAS/14.582/Rev.1)
pdf, 714kb
Good trade and distribution practices for pharmaceutical starting
materials. Revision (QAS/13.552)
pdf, 678kb
Good pharmacopoeial practices concept paper on purpose and benefits
(working document QAS/13.518/Rev.1)
pdf, 187kb
Proposal for a procedure on sampling and market surveillance survey
(QAS/12.510)
pdf, 394kb
QAS/14.598 - Model guidance for the storage and transport of time &
temperature-sensitive pharmaceutical products
pdf, 555kb
QAS/14.598 - Consolidated abbreviations and glossary
pdf, 1.02Mb
plus many new monographs for the Intl Pharmacopoeia.
Well done, WHO!
Wilbert
Wilbert Bannenberg, public health consultant
Founder and co-moderator of E-drug
Private email: wjb@wxs.nl
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