Transcript HANDLING OF INVESTIGATIONAL PRODUCT

PHARMACY AND PRODUCT ACCOUNTABILITY
By J.Thitiri
KEMRI-Wellcome Trust Research Programme
Kilifi, Kenya
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 IP
Control of the IP
Storage 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
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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