By J.ThitiriKEMRI-Wellcome Trust Research Programme

Kilifi, Kenya

PHARMACY AND PRODUCT ACCOUNTABILITY

Version: 14-Nov-2009

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

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

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

As a monitor…..

• Ensure presence of essential documents related to the IP.

• These should cover:Labeling of the IPControl of the IPStorage and environmental monitoring of the IP.Subjects’ compliance and accountability

Version: 16-Dec-2009

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

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

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

Thank you

Version: 16-Dec-2009