| Introduction |
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1.1 Cross-cutting pharmaceutical quality assurance issues |
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1.2 International collaboration |
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6 | (2) |
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2 Quality control -- specifications and tests |
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8 | (12) |
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2.1 The International Pharmacopoeia |
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8 | (2) |
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8 | (1) |
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2.1.2 Workplan 2016--2017 |
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8 | (2) |
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2.2 Specifications for medicines, including children's medicines and radiopharmaceuticals |
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10 | (5) |
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2.2.1 Maternal, newborn, child and adolescent health medicines |
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10 | (1) |
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2.2.2 Antituberculosis medicines |
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11 | (1) |
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2.2.3 Antiviral medicines |
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12 | (1) |
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2.2.4 Medicines for tropical diseases |
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12 | (1) |
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2.2.5 Other anti-infective medicines |
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13 | (1) |
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14 | (1) |
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2.2.7 Radiopharmaceuticals |
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14 | (1) |
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2.3 General monographs for dosage forms and associated method texts |
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15 | (1) |
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16 | (4) |
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3 Quality control -- International Reference Materials (International Chemical Reference Substances and Infrared Reference Spectra) |
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20 | (1) |
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4 Quality control -- national laboratories |
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21 | (2) |
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4.1 External Quality Assurance Assessment Scheme (EQAAS) |
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21 | (1) |
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4.2 Guidance on testing of "suspect" substandard/spurious/falsely-labelled/falsified/counterfeit medicines |
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21 | (1) |
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4.3 Recommendations from the meeting on regulatory guidance for multisource products |
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22 | (1) |
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5 Prequalification of quality control laboratories |
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23 | (2) |
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5.1 Update on the prequalification of quality control laboratories |
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23 | (1) |
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5.2 Update on WHO quality monitoring projects |
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23 | (1) |
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5.3 Revision of the procedure for assessment of quality control laboratories |
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24 | (1) |
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6 Quality assurance -- collaboration initiatives |
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25 | (2) |
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6.1 International meetings of world pharmacopoeias |
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25 | (1) |
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6.2 Good pharmacopoeial practices |
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25 | (1) |
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6.3 Inspection guidelines and good practices |
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26 | (1) |
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7 Quality assurance -- good manufacturing practices |
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27 | (2) |
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7.1 Update of WHO good manufacturing practices: validation |
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27 | (1) |
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7.2 Heating, ventilation and air-conditioning (HVAC) |
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27 | (1) |
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7.3 Update and recommendations from the inspectors' meeting |
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28 | (1) |
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29 | (2) |
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8.1 Local manufacturing of essential medicines |
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29 | (1) |
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8.2 WHO Global Model Regulatory Framework for Medical Devices |
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30 | (1) |
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31 | (6) |
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9.1 Biowaiver list based on the WHO List of Essential Medicines |
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31 | (1) |
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9.2 International Comparator Products List for equivalence assessment of interchangeable multisource (generic) products |
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31 | (1) |
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9.3 Good regulatory practices |
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32 | (1) |
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9.4 Collaborative procedure for stringent regulatory authority-approved medicines |
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32 | (1) |
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9.5 Recommendations from the meeting on regulatory guidance for multisource products |
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33 | (4) |
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10 Prequalification of priority essential medicines and active pharmaceutical ingredients |
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37 | (2) |
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10.1 Update on the prequalification of medicines |
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37 | (1) |
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10.2 Update on the prequalification of APIs |
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37 | (2) |
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11 Nomenclature, terminology and databases |
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39 | (2) |
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11.1 Quality assurance terminology |
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39 | (1) |
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11.2 International Nonproprietary Names (INN) for pharmaceutical substances |
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39 | (1) |
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11.3 Revision of guidance on representation of graphic formulae |
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39 | (2) |
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41 | (1) |
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13 Summary and recommendations |
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42 | (6) |
| Acknowledgements |
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48 | (23) |
| Annex 1 WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines |
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71 | (16) |
| Annex 2 The International Pharmacopoeia: revised concepts and future perspectives |
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87 | (4) |
| Annex 3 Prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies |
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91 | (12) |
| Annex 4 WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices |
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103 | (76) |
| Annex 5 General background notes on the list of international comparator pharmaceutical products |
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179 | (2) |
| Annex 6 Equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients according to the Biopharmaceutics Classification System, as an appendix to the WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 7, WHO Technical Report Series, No. 992, 2015) |
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