5.6 QUALITY RISK MANAGEMENT

In most of the countries compliance with GMP throughout the product life cycle largely

gives assurance regarding the good quality of the product. However, any loose control

can put the patient in risk because of the lower quality of medicine. Regulatory

authorities can improve the quality of the product within the limit of resources

available if:

i. Assessment of individual risk related to specific products, starting material is

performed.

ii. Recognition of hazards at specific stages of production and/or distribution are

done

QRM is a process that is related to all countries and has a rationale to understand

risk. It has measures to prevent and mitigate all risks by appropriate and robust controls.

The aim is:

i. To ensure the quality of a product.

ii. To eliminate risk at the patient's end.

iii. To ensure the elimination of risks at the point of origin.

iv. To protect the company from loss generated because of inadequate quality

products.

v. To make industries manufactures to adopt a risk-based approach throughout the

life cycle of the product.

vi. To manage risk to the quality of product throughout its life cycle to maintain

benefit/risk balance.

Characteristics of QRM

i. It is a risk-based approach.

ii. It is a systematic process.

iii. It involves:

a. Assessment

b. Control

c. Communication

d. And a review of the risks to the quality of the product.