Doctorate in TQM,M.Sc, MBA Quality Management, Investigation | Audit Management | Validation | Qualification | Deviations | Risk Management | GMP | Data Integrity
𝗪𝗛𝗢 𝗗𝗿𝗮𝗳𝘁 𝘄𝗼𝗿𝗸𝗶𝗻𝗴 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗼𝗻 𝗴𝗼𝗼𝗱 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗳𝗼𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 ✓ World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Products (ECSPP) adopted the WHO good practices for national pharmaceutical control laboratories guidelines which were published as Annex 3 of the WHO Technical Report 92 Series, No. 902, 2002. ✓ These guidelines were subsequently revised and published as Annex 1 of 93 the WHO Technical Report Series, no 957, 2010 and was renamed as "WHO good practices for pharmaceutical quality control laboratories". Since the last revision of the guidelines, the experience from inspections of pharmaceutical quality control laboratories has enabled WHO to identify sections requiring clarification and the necessity to add new sections. ✓ The present document provides advice on the quality management system (QMS) within which the analysis of pharmaceutical products by quality control laboratories (QCL) should be performed to ensure that accurate and reliable results are obtained. Compliance with the recommendations provided in these guidelines will help promote international harmonization of good laboratory practices for pharmaceutical quality control laboratories and facilitate mutual recognition of test results. ✓ This guideline is consistent with the requirements of the WHO guidelines for good manufacturing practices (1) and the International Standard ISO/IEC 17025:2017 (2), providing detailed guidance for laboratories performing quality control testing of medicines. ✓ The good practice outlined below is to be considered as a general guide and it may be adapted to meet individual needs provided that an equivalent level of assurance is achieved. For items section 4.3[ Performance management], section 4.4 [Quality Risk management], section 4.5 [Crisis management], section 4.6 [Communication management] and section 6.7 [Measurement uncertainty] from the new section 4 on “Planning and strategic management”, a period of adaptation from the publication of this document will be given to allow laboratories to properly implement these new requirements. #who #qualitycontrol #laboratory #pharmaceuticalindustry #learning #knowledgesharing #gmp
