Objectives cont… Follow-up and regular monitoring of the quality of manufacturers and products.
{"Image DocumentName": "Objectives cont\u2026Follow-up and regular monitoring of the quality of manufacturers and products.", "Image ImageDescription": "Ensure re-qualification and update of the list of prequalified products and manufacturers as new products and manufacturers meet the standards. Ensure the appropriate control of variations and changes. Develop the local capacity for quality production and clinical studies. National regulatory authorities (DRA) are involved in dossier assessment and inspections. Producers receive invaluable specific technical feedback. Help the national DRA to build up capacity in assessment, inspection and control meeting international norms and standards. The Procedure for Assessing the Acceptability, in Principle, of Pharmaceutical Products for Purchase by United Nations Agencies speaks of RE-EVALUATION: At regular intervals. Supplier to communicate any changes. Re-inspection at least every 3 years. Change to key personnel or the manuf site could also result in re-insp. Re-evaluat of dossier every 3 years or sooner if change of formula, manuf method/site. Requal generic: Updated dossier, incl any changes that may impact\u2026, letter of invitation for an inspection of manuf site/CRO, sample of all commercial present s. Requal innovator: Updated dossier, incl any changes that may impact\u2026, if no changes \u2013 only a letter confirming this is ok, WHO may request copies of latest inspection reports by DRAs, in some cases WHO may decide to do insp s. RE-EVALUATION also if. fraud/omission (post-PQ) batch not in compliance with agreed spec s. serious complaints. if suspension of supply \u2265 1 year. if changes to API, formulation, manuf method/facility or other production aspects. Some dossiers very poor quality, failed inspections or postponed scheduled inspections at the last minute. Quality of dossiers has improved, increased willingness to upgrade manufacturing sites. WHO cannot take responsibility for the time taken to submit additional data requested or time taken to take corrective action\u2026Some NDRAS have adopted procedures from PQ and may fast-track PQ d dossiers.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}