3. QRM application during product development: There are various stages in product

development. QRM procedure application evolves through these various stages.

Such as:

a. The first QRM exercise should be done once Quality Target Product Profile (QTPP)

is defined and the candidate medicines pre-formulation work is done. There are

several gaps in knowledge at this stage, so various tools like flowcharts, decision

trees, fault-tree analysis, matrices, cause and effect diagram, etc. are used in such

a situation.

b. When the product has gone through the next stage of development, a detailed

risk analysis should be done, which is associated with API and FP both. Risk can

cover stability, bio-availablity, and patient safety.

c. With the more advancement of product knowledge more detailed exercises of

QRM can be done. These exercises will concentrate on the areas which have high

priority risk.

4. QRM application during validation and qualification: Process validation involves

the generation as well as evaluation of data throughout the process, i.e. from

development scale to full-scale production. This property of process validation

resembles with QRM process because QRM also deals with the product life cycle.

The embracement of the product life cycle concept provides scientific assurance of

consistent delivery of the quality product. This scientific assurance should be build

up from the starting of the product life cycle and should be ensured early in the

development phase in both cases (product and process development).