Transcript Product - Nuclear Sciences and Applications

Radiopharmaceutical Production
Product Release
STOP
Product Release
•
The finished product should be held
in quarantine while it is being tested
for conformity to pre-determined
specifications. When all the
necessary requirements of quality
assurance for adherence to GMP are
demonstrated, the batch is released
for patient use. The manufacturer
should designate clearly the finished
product release authorization (either
a designated person or a position).
Contents
•
•
•
•
•
General Aspects of Product
Release
Authorized Person
Example of simple FDG Batch
Record
Example of detailed FDG Batch
Record
Transport of the
Radiopharmaceutical
STOP
Radiopharmaceutical
Production
General Aspects of Product
Release
•
Product Release
Contents
General Aspects of
Product Release
Authorized Person
Example of simple FDG
Batch Record
Example of detailed FDG
Batch Record
Transport of the
Radiopharmaceutical
STOP
•
A product failing to meet the established specifications or other
quality criteria (e.g., non-compliance with GMP) must be
rejected. Circumstances leading to failed product should be
carefully evaluated. The cause of failure should be investigated,
and procedures should be established for systematic evaluation
of a failed product (a written and approved SOP should be
available). Reprocessing may be performed in some instances,
but only as per previously written and approved procedures.
The reprocessed product must conform to all the specifications
prior to approval for release. Frequency of reprocessing must
be absolutely minimal. Excessive reprocessing represents a
poorly validated process and loss of control in the system.
A representative sample(s) of the batch must be set aside for
retrospective testing in case of a customer complaint or query
related to the product quality. Reserve sample consists of at
least twice the quantity necessary to perform all the tests
required to determine product quality. The duration of reserve
sample retention varies among various GMP guidelines but
most require 1 year.
Radiopharmaceutical
Production
Product Release
Contents
General Aspects of Product
Release
The final product may be released by the Authorized Person for
use once all the following conditions have been met. These
conditions are recommended but may not be required.
•
General Aspects of
Product Release
Authorized Person
•
•
Example of simple FDG
Batch Record
Example of detailed FDG
Batch Record
Transport of the
Radiopharmaceutical
STOP
•
All the pre-release QC tests on the batch record have been
completed and the product meets all the specifications,
The chemist who performed the QC tests has initialed and
dated the “performed by” section in the batch record,
The tests results have been verified and the “verified by” section
of the batch record has been initialed and dated by a chemist
who did not perform the tests, but witnessed the entry.
The Authorized Person has reviewed the document and signed
off on the Release Approval line and entered the date and time
in the appropriate place on the batch record. Under certain
circumstances, the chemist who performed the synthesis can
also act as the authorized person.
Authorized Person
Radiopharmaceutical
Production
•
In any GMP laboratory, there must be at least one person who
has the authority to release the product for human use (qualified
person, authorized person). This is the person who is ultimately
responsible to ensure the product conforms to the required
quality specifications and is safe to use. This person should
have a degree in physical, chemical, pharmaceutical or
biological sciences and be familiar with all aspects of GMP and
quality management. The qualified person ensures that
manufacturing and testing was performed in compliance with
GMP standards and the national pharmaceutical manufacturing
regulations. The facility management must have confidence the
Qualified Person will perform his/her duties responsibly. The
qualified person will usually perform other job functions (such
as, management of the facility) and is not restricted exclusively
to product release.
•
The qualified person should have:
– Formal training in GMP
– 2 years practical experience working under GMP license
– Authorization by the facility to release radiopharmaceuticals.
This may require that the person be a certified Nuclear
Radiopharmacist or Pharmacist depending on location and
regulations
Product Release
Contents
General Aspects of
Product Release
Authorized Person
Example of simple FDG
Batch Record
Example of detailed FDG
Batch Record
Transport of the
Radiopharmaceutical
STOP
Simple FDG Batch Record
Radiopharmaceutical
Production
•
Product Release
Contents
General Aspects of
Product Release
Authorized Person
•
Example of simple FDG
Batch Record
Example of detailed FDG
Batch Record
Transport of the
Radiopharmaceutical
STOP
•
This is a simple FDG batch record where the FDG is being
produced on a commercial FDG synthesizer. The list of
materials and supplies is rather short and the specific step by
step instructions are contained in a separate SOP for the
synthesis of FDG. There is just a checklist for the operator to
be sure that everything has been done to start the synthesis.
The last page of the batch record is a blank page where the
print out from the synthesizer is pasted. This page is kept with
the batch record in storage.
The see the batch record, click on the link. BATCH RECORD
Detailed FDG Batch Record
Radiopharmaceutical
Production
•
In the more detailed FDG batch record, there are two sections.
The first is the instructions for the procedure in more detail than
we saw in the first example and then there is a separate section
with the QC tests. These tests must be completed prior to the
release of the product with the exception of the sterility test
which is done after the fact.
•
•
The see the batch record, click on the link. BATCH RECORD
To see the QC test sheet, click on the link. QC TESTS
Product Release
Contents
General Aspects of
Product Release
Authorized Person
Example of simple FDG
Batch Record
Example of detailed FDG
Batch Record
Transport of the
Radiopharmaceutical
STOP
Radiopharmaceutical
Production
Transport of the
Radiopharmaceutical
•
The transport of the final product will be covered by local
regulations. A summary of the IAEA standards for transport of
these materials can be found in the following publication.
•
IAEA Publication 1225
Product Release
Contents
General Aspects of
Product Release
Authorized Person
Example of simple FDG
Batch Record
Example of detailed FDG
Batch Record
Transport of the
Radiopharmaceutical
STOP
Return to Main Menu