WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 1019 - Fifty-third Report (Geneva, 22–26 October 2018)
(2019; 303 pages)


The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating, ventilation and air-conditioning systems (HVAC) – illustrative part; Guidance on GMP for Validation, including the general main text, analytical procedure validation, validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification system-based classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.

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