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

i. Training and education

ii. Responsibilities

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,

HAZOP, FMEA, etc.

TRANSFER FROM R&D TO PRODUCTION (PROCESS, PACKAGING AND

CLEANING) AND GRANULARITY OF TT PROCESS (API, EXCIPIENTS, FINISHED

PRODUCTS, PACKAGING MATERIAL)

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

transferred to RU.

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

to RU.

Packaging: Packaging transfer has the same importance as production transfer.

110 Industrial Pharmacy II

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

substances.

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.