procurement and storage of investigation product

1. Presented By:- Mohd Farman
M. Pharm (Pharmacy Practice)
SGRR University , Dehradun

2.  A Pharmaceutical product being tested or use as a
reference in a clinical study. An investigational
product may be an active chemical entity or a
formulated dosage form.

3.  A clinical investigator involved in a clinical trial is responsible
for ensuring that an investigation is conducted according to the
signed investigator statement, the investigational plan, and
applicable regulations; for protecting the rights, safety, and
welfare of subjects under the investigator's care, and for the
control of drugs under investigation.

4.  Investigator has the primary responsibility for
investigational product accountability at the study site
 Responsibility to be mention upfront in the study
agreement
 Maintain record of the products delivery to the study
site, the inventory at the site, the use by each subject,
the return to the sponsor. these recode should include
Dates, quantity, batch/ serial no., expiry date

5.  STEP 1-The research team needs to Notify (if necessary)
the Pharmacy of subject enrollment or screening to secure
investigational drug(s).
 STEP 2- The Department of Pharmacy needs to
1. Order investigational drug(s) according to the protocol
and sponsor’s instructions.
2. Receive and verify investigational drug(s).
3. Record the receipt of IP .
4. Store IP according to the protocol.

6. Following point should be check and verified during receiving of
investigational drug
 Drug name, dosage form and drug strength
 Package size and quantity
 Lot or batch number
 Kit, bottle or vial numbers
 Expiration or retest date
 Damage

7.  Establish controlled access to investigational drugs by only
authorized personnel. Access to keys or pass codes to
investigational drug storage should be limited accordingly.
 Store investigational drugs in dedicated storage shelf,
cabinet, refrigerator and freezer space separate from non-
research drugs and clinical supplies.
 Label storage compartments with study and drug
information.
 Establish separate compartment for each drug, strength and
lot under the same study.
 Store used, returned and expired drugs separate from
working stock.

8.  Font size not less than 7pts and minimum of 3mm in
between lines
 Legible
 Multi colored for clear distinguishing from
background
 Printed in English and perhaps local language
 No longer sentences
 Generic name bolder than brand name
 Diagrams can be used to reduce the need of the text

9.  Physical, chemical, Pharmaceutical properties of and
the formulation of the IP must be documented to
permit appropriate safety measure to be taken during
the course of the study
 Instruction of the storage and handling of the dosage
form should be documented