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
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
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