QRM is a process that relates to all countries and has a rationale to understand risk.
It has measures to prevent and mitigate all risks by appropriate and robust controls.
QRM Application in Pharmaceuticals
iii. QRM application during product development
iv. QRM application during validation and qualification
v. QRM application during commercial manufacturing
QRM related guidelines: Q9 of ICH and WHO expert committee on specification
for pharmaceutical preparations 47th report, Annexure 2, and TRS-981.
Tools of QRM: A variety of tools either alone or in combined form can be used for
the QRM purposes. There is no single or combined tool which is applicable to the
entire situation. The main criteria for selecting the tool are that it should support the
key attributes of good risk assessment, e.g. FTA, HACCP, flowcharts, check sheets,
TRANSFER FROM R&D TO PRODUCTION (PROCESS, PACKAGING AND
CLEANING) AND GRANULARITY OF TT PROCESS (API, EXCIPIENTS, FINISHED
Transfer process is one of the most critical steps in technology transfer. Certain things
that should be ensured by sending unit are as follows:
i. The RU should be accommodated the intended production capacity.
ii. Consideration should be given to the level and depth of the detail which is to be
iii. Consideration should be given to the technical expertise, site technology and
capabilities of RU. It is done so that plans may put in place at the RU.
iv. SU should jointly develop a protocol with RU for relevant information transfer
and to help RU in developing comparable process.
Starting material: The specification and relevant functional characteristics related
with starting material, i.e. API and excipients which are to be used at RU should be
consistent with materials used at SU.
Finished pharmaceutical product: Detailed information related with qualitative
and quantitative characteristics of the finished product should be provided by SU
Packaging: Packaging transfer has the same importance as production transfer.
Cleaning: It is very much necessary to have adequate cleaning procedure so as:
i. To ensure the best quality of product and
ii. To protect the product from contamination
iii. To protect the product from cross-contamination from the API or other
Analytical method transfer: In pharmaceutical sciences, analytical methods are the
techniques which deals with the process(es) to identify quantitatively or qualitatively
a substance or its components in the pharmaceutical preparation (solution, mixture,
etc.). These techniques are also used for determining the structure of chemical
components of the pharmaceutical product. Technology transfer process (as per WHO
guidelines) analytical method transfer is a critical step that ensures RU capabilities to
produce and test the same product as by SU. The analytical method transfer comes
under quality control section. All the analytical testing methods that demonstrate
compliance of product (which is to be transferred) will be transferred with registered
specifications. Analytical method used to test pharmaceutical products, starting
material, packaging components, cleaning should be first implemented in the laboratory
before process validation at RU. Process validation sample may be tested at RU, SU,
or at any other 3rd laboratory.
Premises and equipment: One of the major requirements needed for the
manufacturing of a pharmaceutical product is premises and the other one is equipment.
The premises and equipment should be designed, constructed, located, adapted and
maintained to suit the operations needed to be carried out. It is a layout of premises
and equipment that have a major effect on cleaning, maintenance, and risk of error
during production and finally affect the quality of the product.
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