Contiene : algoritmos y anexos.

General policy: Cross-Cutting pharmaceutical quality assurance issues, international collaboration. Quality control – specifications and test for The International Pharmacopoeia: update and workplan, general policy, general chapters, general monographs for dosage forms and associated method texts, specifications for medicines, including children´s medicines and radiopharmaceuticals. Quality Control – international reference materials (International Chemical Reference Substances and Infrared Reference Spectra): report of the custodian centre, update on International Chemical Reference Substances, including report of the dedicated Expert Committee on Specifications for Pharmaceutical Preparations subgroup on International Chemical Reference Substances, general policy. Quality control – national laboratories: External Quality Assurance Assessment Scheme, considerations for requesting analysis of medicines samples and model certificate of analysis, guidance on testing of ¨suspect¨ falsified medicines. Prequalification of quality control laboratories: update on the prequalification on quality control laboratories, update on WHO quality monitoring projects. Quality assurance – collaboration initiatives: international meetings of world pharmacopoeias, good pharmacopoeia practices. Quality assurance – good manufacturing practices: guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems, WHO good manufacturing practices: validation, including main principles and specific texts (water, cleaning, computerized systems, qualifications of systems and equipment, non-sterile), guidance on good practices for desk review for good manufacturing practices, confirmation in lieu of on-site assessment. Update and recommendations from the inspectors ‘meeting. Regulatory guidance: regulatory requirements on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Biowaiver list based on the WHO Model List of Essential Medicines, collaborative procedure for the assessment and accelerated national registration of medicines and vaccines approved by stringent regulatory authorities, good practices for implementing the collaborative procedures, good regulatory practices, quality management systems for national regulatory authorities. Prequalification of priority essential medicines an active pharmaceutical ingredient: update on the prequalification of medicines, update on the prequalification of active pharmaceutical ingredients. Nomenclature, terminology and databases: definition of ¨stringent regulatory authority¨, quality assurance terminology, guidelines and guidance texts adopted by the committee, International Nonproprietary Names for pharmaceutical substances, guidance on the graphic representation of pharmaceutical substances.