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By J.Thitiri KEMRI-Wellcome Trust Research Programme Kilifi, Kenya

By J.Thitiri KEMRI-Wellcome Trust Research Programme Kilifi, Kenya. PHARMACY AND PRODUCT ACCOUNTABILITY. E6 Guidelines. I nvestigator responsibility E6 4.6.1: “Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.”

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By J.Thitiri KEMRI-Wellcome Trust Research Programme Kilifi, Kenya

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  1. By J.ThitiriKEMRI-Wellcome Trust Research ProgrammeKilifi, Kenya PHARMACY AND PRODUCT ACCOUNTABILITY

  2. E6 Guidelines Investigator responsibility • E6 4.6.1: “Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.” • E6 4.6.2- 6 :Other related resposibilities Sponsor responsibilities • E6 5.14: “Supplying and handling investigational product”

  3. Sponsor responsibilities • Provide an up to date IB • Develop clear SOPs for handling, storage and dispensing of IB. • Instruction on return of unused IP • Establishing Quality control for IP.

  4. At site • Investigator needs to keep and maintain proper auditable records on handling, storage and use of investigational product at site.

  5. As a monitor….. • Ensure presence of essential documents related to the IP. • These should cover: • Labeling of the IP • Control of the IP • Storage and environmental monitoring of the IP. • Subjects’ compliance and accountability

  6. So what do you check …….? • Current up to-date Investigators Brochure on file. (For marketed drugs/products, use information excerpts found with the product) • SOPs on all aspects of handling , storage, dispensing and use of the IP. • Shipping and delivery records- to include • Dates of shipment/ delivery, • Quantities, • batch/lot numbers, • manufacture and expiry dates, • unique code numbers assigned to the product and the trial subjects. • Up to date inventory of the IP – Stock management

  7. Contd… 5. Storage records- e.g. temperature charts , hygrometers, cold chain records, other special instructions on handling the Investigational product such as radioactive materials. 6. Drug dispensation records – on use by individual study patients. 7. Study drug reconciliation 8. Records on return of unused IP or destruction

  8. Other areas to monitor…. • Qualification of handlers of IP in compliance with sponsor specification – i.e. appropriate duty delegation records in relation to IP. • Records of correct usage and compliance eg in source documents • Real time dosing of study subjects. • Calibration and validation of all equipment used in handling and or dispensing IP e.g. freezers, temperature monitors, weighing scales etc.

  9. Thank you ?

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