1. By J.Thitiri KEMRI-Wellcome Trust Research Programme Kilifi, Kenya PHARMACY AND PRODUCT ACCOUNTABILITY Version: 14-Nov-2009

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” Version: 16-Dec-2009

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. Version: 16-Dec-2009

4. At site Investigator needs to keep and maintain proper auditable records on handling, storage and use of investigational product at site. Version: 16-Dec-2009

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 Version: 16-Dec-2009

6. So what do you check …….? 1.Current up to-date Investigators Brochure on file. (For marketed drugs/products, use information excerpts found with the product) 2.SOPs on all aspects of handling, storage, dispensing and use of the IP. 3.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. 4.Up to date inventory of the IP – Stock management Version: 16-Dec-2009

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 Version: 16-Dec-2009

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. Version: 16-Dec-2009

9. Thank you ? Version: 16-Dec-2009