World Health Organization
منظمة الصحة العالمية
Organisation mondiale de la Santé

Good manufacturing practices inspection training, 16–20 September 2012

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The Regional Office for the Eastern Mediterranean has conducted a training course on Good Manufacturing Practices (GMP) inspection in Qatar from16 to 20 September 2012. The training aimed at building the capacities of the Pharmacy and Drug Control Department of the Supreme Council of Health in Qatar on GMP inspection function and compliance. The training was attended by newly hired staff for inspection and dossier assessment function at the Department of Pharmacy and Drug Control.

Various GMP related topics were tackled during training sessions including: investigation of out of specification results, corrective action and preventive action, change management, supplier qualification/vendor certification programme, recall system, training and audits, annual product review, documentation control, production and process control, material control. GMP for active pharmaceutical ingredients and systems approaches for inspection pharmaceutical plants were also highlighted.

The international conference on harmonization guidelines related to stability testing, product development, quality risk management and pharmaceutical quality system was discussed in detail with case examples to enhance the understanding of basic concept. The quality and regulatory standards were discussed with respect to each topic. The training sessions encouraged interactive dialogue exchange between trainers and course participants.  The training was rated over a series of indicators to measure participant’s satisfaction with content, material and speakers.