|
Standard Operating Procedure
|
SOP No:
Version: 1
Effective Date:
|
|||
|
Title: Receiving IMP
|
||||
|
|
NAME
|
SIGNATURE
|
DATE
|
|
|
PREPARED BY
|
|
|
|
|
|
REVIEWED BY
|
|
|
|
|
|
QA UNIT
AUTHORITY
|
|
|
|
|
|
APPROVAL
AUTHORITY
|
|
|
|
|
1.
Purpose/scope
To describe the procedureforreceiving
Investigational Medicinal Product (IMP) for a clinical trial conducted by the
[institution/group], including placing it in quarantine and adding it to the
Pharmacy inventory. This procedure may be supplemented with a trial-specific
pharmacy manual or process document(s).
2.
Templates/forms
IMP01.1 Acknowledgement of
Investigational Medicinal Product Receipt
IMP01.2 Pharmacy Accountability Form
3.
Glossary/definitions
See also: South African
Good Clinical Practice (SAGCP) Guideline; ICH Guideline for Good Clinical
Practice E6; South African Guide to Good Manufacturing Practice and Good
Pharmacy Practice
Essential Documents
Documents which
individually and collectively permit evaluation of the conduct of a clinical
trial and the quality of the data produced (See South African Good Clinical
Practice Guideline, Second Edition. 2006. Appendix C).
Good Manufacturing Practice
That part of Quality
Assurance which ensures that products are consistently produced and controlled
to the quality standards appropriate to their intended use and as required by
the medicine registration or product specification
Good Pharmacy Practice
Standards developed to ensure that all
practising pharmacists and other health care professionals providing medicines
provide a service of high quality for the public and private sector alike.
Investigational Medicinal Product (IMP)
A pharmaceutical form
of an active ingredient or placebo being tested or used as a reference in a
clinical trial, including a product with a marketing authorisation when used or
assembled (formulated or packaged) in a way different from the approved form,
or when used for an unapproved indication, or when used to gain further
information about an approved use.
Investigator Site File (ISF)
Files of Essential
Documents held by the Investigator. NB on occasion the [institution/group]may
also hold the Sponsor's Essential Documents in a Trial Master File, where the
Principal Investigator (PI) assumes a Sponsor-investigator role.
4.
Responsibilitiesand
procedure
If the trial is conducted
outside of [institution/group]facilities the place where IMP is to be stored
(pharmacy or otherwise) should, similarly, be suitable in terms of access
control, capacity and equipment (e.g. for temperature monitoring).
Should the IMP involve
re-packaging of bulk supplies for individual participants, contact the CRC for
advice about whether there is a requirement to comply with regulations over and
above Good Pharmacy Practice (e.g. Good Manufacturing
Practice).
4.1. Acknowledgement of IP
receipt:
4.1.1.
Arrangements
for delivery or collection of IMP are made with the supplier such that its
integrity is maintained throughout the transport process.
4.1.2.
Upon receipt
of IMPs into the pharmacy, the resident pharmacist should notify the trial
pharmacist of the delivery. Either the resident or trial pharmacist should acknowledge
receipt using the IMP Acknowledgement of Receipt Form (IMP01.1), (or alternative document if required by
Sponsor), sending the form back to the appropriate party as required.A separate
IMP01.1 is completed for each type and batch of IMP, being as specific as
possible while maintaining the integrity of the packaging.
4.1.3.
All
documentation accompanying or detailing the delivery are noted and filed in the
Pharmacy file and/or Investigator Site File (ISF). This may include package
inserts, certificates of compliance with GMP Guidelines, certificates of
analysis (test products), or product release certificates (reference products).
If any expected documents are missing, adesignee must notify the pharmacy or
Sponsor without undue delay.
4.1.4.
If the IMP
cannot be immediately added to the pharmacy inventory, it should be labelled
with the protocol number, date of receipt and the word “QUARANTINE”.
4.1.5.
As soon as the
IMP arrives, protocol-specific processes relating to storage of the IMP, such
as temperature monitoring, will be commenced.
4.2. Initial IP
accountability:
4.2.1.
IMP is added
to the pharmacy inventory using an accountability form (IMP01.2).
4.2.2.
Work with one
type of IMP at a time on a clear, clean surface, taking into account what is
known about its toxicity, potency, sensitising potential and risk of
cross-contamination.Ensure that audited/un-audited stock is kept separate to
avoid confusion.
4.2.3.
If there is
more than one container of the IMP, ensure expiry dates/batch numbers are the
same on each (if different, consult the investigator to ascertain if this is
acceptable).
4.2.4.
First establish visually if the
product on the data sheet appears to be what is supplied. Where containers are
received sealed, cross-check labels with the delivery documentation. Ensure details
on any outer boxes correlate with wrapping inside the box and that, for
instance, blisters are filled appropriately. Where containers are received
unsealed, use a clean pill tray or weighing machine (or other equipment
depending on the formulation) to verify the contents; count or weigh the IMP
ensuring it is consistent in appearance (e.g. colour, size and integrity). The
total should be double-checked by the same person or another member of the
team.
4.2.5.
Any deviations between forms IMP01.1 and 2 should be explored
anddocumented.
4.3.
Should members of the trial team need to be blinded
to any of the above procedures, this should be documented in detail in a
Pharmacy Manual or other trial-specific document.
5.
Document history:
|
Version
No.
|
Date
|
Reviewer
|
Details
of changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
