Implementation Of Change Control

Change control is defined as : “A formal system by which qualified representatives of appropriate disciplines review propose or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.”

The implementation of a change control system is an important and necessary step in the validation approach for equipment and facilities. Vital to any change control system is its efficiency in that it does not require too much time and effort to handle changes.

In order to design an efficient change control system, the following aspects need to be taken into consideration: Early categorization of a change as major or minor change (i.e., catalogue).
This should speed up the decision and approval time of a change. Easy and logical way of document flow (production engineering, quality assurance, production). Easy and logical decision tree for major or minor changes or planned or emergency changes.
It is not only good practice but also essential that a requested change is only implemented after the appropriate change control procedures and approvals have been followed. Time and money are often wasted because a change was not correctly evaluated (major or minor) or personnel were not familiar with the best practice for change control procedures.

 It is crucial for an efficient change control process that the production, engineering, and validation departments are working together very closely. Clear change control procedures have to be in place for all eventualities. This must include instructions for situations in which the supervisory or management personnel are not present when the problem occurs. In such a case, for example, a change or correction might be implemented quickly by the maintenance or operational personnel that must then be reviewed and approved by management within 24 hr.

Systematic flow of Change Control:

Figure: Flow of Change Control

REFERENCES

1. U.S. Food and Drug Administration. 21 CFR 210/211 Good Manufacturing Practice.

Fed Reg (2001).

2. U.S. Food and Drug Administration. Guide to Inspection of Validation Documentation

(1995).

3. Recommendation on Validation Master Plan, Installation and Operational Qualification,

Non-Sterile Process Validation and Cleaning Validation, Pharmaceutical Inspection

Co-Operation Scheme PIC/S PI 006 (2002).