The main advantage of QRM application is that there can be flexibility in a number

of batches for confirmation or validation, whereas in validation there is a fixed

number of batches to be taken. So, QRM ensures flexibility as per type and depth of

knowledge to be gained. In case of qualification, QRM principles can be used to

determine its scope, monitoring, as well as the optimal schedule for maintenance,

requalification and calibration.

WHO Guidelines for Transfer of Technology 73

5. QRM application during commercial manufacturing: Certain points are to be taken

care while implementing QRM in commercial manufacturing:

a. QRM implementation does not neutralise the manufacturer's obligation to comply

with regulatory requirements.

b. The risk assessment and control responsibilities should be designated to relevant

personnel at the appropriate level of hierarchy within the organisation.

c. Special focus must be given to risk assessment and risk control throughout the

life cycle of a product.

The key areas of focusing are:

a. Product quality risks

b. Adverse effect on patient's health due to quality defects in the product.

c. Interruption in the supply of products to patients.

d. Risk related to GMP and regulatory compliance.

e. Multisite and multiproduct risks.

f. Any change in the existing facility or establishment of new facility.

After risk assessment and risk control, risk review should be done. A report should

be prepared and communicated to stakeholders. The areas of focusing during the

implementation of QRM in commercial manufacturing includes system focus, process

focus and product focus.

QRM should be integrated into two ways to get benefits across a broad spectrum of

operations (Table 5.1).

QRM related guidelines

i. Q9 of ICH

ii. WHO expert committee on specification for pharmaceutical preparations 47th

report, Annexure 2, TRS-981.

Tools of QRM

A variety of tools either alone or in combined form can be used for QRM purposes.

There is no single or combined tool which applies to all the situation. The main criteria

for selecting the tool are that it should support the key attributes of good risk

assessment.