Attention: WHO new quality projects list for review please comment on respective guideline

• Current projects
  
  
  Attention: WHO new quality projects list for review please comment on respective guideline 
  
  
  The following list of items represents the work that is currently underway within the Quality Assurance team:
  
  
  New texts under review for medicines quality assurance
  
  
  Should you have any comments thereon please send these as requested in the box on the first page of each document. You will need to use a downloaded/copied version of the table for comments.
  ·         Table for comments
  doc, 51kb
  ·         Table example
  pdf, 48kb
  
  
  ·         Guidelines
  
  
  ·         Good pharmacopoeial practices. Glossary (QAS/16.677) pdf, 652kb
  
  
  ·         Guidelines on validation - appendix 6: validation on qualification of systems, utilities and equipment QAS/16.673)
  
  
  
  
  ·         Equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients according to the biopharmaceutics classification system (QAS/16.672)
  
  ·         Guidelines on validation - Appendix 4: Analytical method validation (QAS/16.671)
  
  ·         Guidelines on validation - appendix 5: validation of computerized systems (QAS/16.667)
  
  Guidelines on validation (QAS/16.666)
  
  WHO global model regulatory framework for medical devices including IVDs (QAS/16.664/Rev.1)
  
  Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by un agencies (QAS/16.656/Rev.1)
  
  
  Proposal for update
  ·         Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (QAS/15.639/Rev.1)
  
  Recommendations on the content of a survey protocol for surveys of the quality of medicines (QAS/14.590)
  
  General background on the list of international comparator pharmaceutical products (QAS/14/586/Rev.4)
  
  
  ·         Draft international comparator list
  
  Good pharmacopoeial practices concept paper on purpose and benefits (working document QAS/13.518/Rev.1)
  
  Proposal for a procedure on sampling and market surveillance survey (QAS/12.510)
  
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