med 18

 

The verification of QRM must be based on:

i. Expert advice and scientific study.

ii. In-plant observation, measurement and evaluation.

A third-party review may also prove to be useful. The third-party should be

independent and perform the comprehensive review of the QRM process.

Risk communication and documentation: Communication involves the sharing of

each step from data collection to risk assessment, from risk assessment to risk control

and from risk control to risk review process with each stakeholder. It makes them

more responsible and will ensure their commitment and support for QRM.

Documentation is a must at each step of QRM. Each information, adaptation,

changes, decision, amendments so on and so forth should be well documented, duly

signed and kept preserved for the record.

 Fig. 5.5: The steps involved in risk control

72 Industrial Pharmacy II

5.7 QRM APPLICATION IN PHARMACEUTICALS

1. Training and education: The effective implementation of QRM in pharmaceuticals

majorly depends upon the following:

a. The training of managerial, technical and supporting staff involved in QRM.

b. Co-ordination and co-operation between producers, trades and responsible

authorities. Joint training are the major tool for increasing this co-operation.

c. Understanding of QRM by industrial employees.

2. Responsibilities: Successful implementation of QRM also depends upon a clear

understanding of responsibilities by personnel. These understanding can be

effectively enhanced by preparing a cross-functional matrix of responsibilities and

accountability that are assigned. These assigned responsibilities should be shared

with all relevant staff. During the assigning process, the pharmaceutical manufacturer

duty is to ensure that personnel or relevant staff (to which the responsibilities are

going to be assigned) should be experienced and expertise enough in the field. The

external consultants, contractual staff, staff from different departments can also be

added in the cross-functional matrix. Effective leadership should also be there which

will take responsibility for co-ordinating QRM through various functions and

departments.