Procedure for Change Control

1.0 Introduction

Change control – it is defined as system to approve, document, evaluate and implement changes of equipment to make sure that a constant qualified status of system is obtained

1.1 Purpose

This document provides the guidance for change control of utilities and equipment and other computerized systems. It is based on ICH Q7a & experiences from peers

1.2 Scope

The guidelines provided apply to equipment used in API manufacture but not for analytical equipment

1.3 Impact

Any repair or replacement of major part of an equipment and maintenance work shows effect on the performance of process and product quality

These changes may due to shifting or re arrangement of support systems like water systems, HVAC, CIP systems and varying environmental conditions.

2.0 Responsibilities

2.1 Process owner

The process owner must take responsible for the changes and follow valid change control procedure

The impact caused by the change should be classified by the owner as to minor or major. The insights from quality department should also be considered in assessing the impact

List of the changes which don’t incur any changes on product quality should be prepared by the owner

2.2 Quality Department

If the change has a major impact on the quality of the product then the quality department should involve in change control

This department is used for implementation & maintenance of change control system

Finally the standard changes list should be given by the quality department

2.3 Process Owner & Quality unit

Every technical change should be assessed and measures for combating the issue should be taken by the quality unit and process owner collectively

3.0 Critical change

The range and impact of the change should be assessed and is stated as “Critical” in the following conditions:

If the component changed

Can contact directly with product or products components & the change is not “like to like”

Can change in product quality like crystal form & size, impurity profile, solvent and stability of API

Records the alarm functions critical to the process

Is used to work in compliance with registered process

Can Influence performance and quality of support systems like water or HVAC or steam.

Is used to ensure control to critical functions or data, performs investigations relevant to batch release, Control shelf life or batch status, Control production process, Transfers critical data to another relevant system, ensure warehouse critical conditions, Controls calibration or maintenance of critical equipment.

In the above conditions the changes should be carefully assessed and reviewed before implementing

4.0 Procedure

A request for change should be made initially in formal manner with a form and signature

Based on the request the impact of the change on quality of the product is defined as either as minor or major change

The rules for the decision should be clear as to it is major or minor and the person in charge of making the decision with proper justification

For change control management the decision is to be taken by the process owner and quality department. Technical department should sign the document and according to the company procedure quality department either acts as a approver or can periodically perform self-inspection audits       

If there is no impact on product quality then it can be implemented by owner with appropriate documentation

Minor changes can be done in short period and efficiently with the help of standard changes list approved by quality department

In case of major change quality department should be involved and a thorough action plan should be made.

After the plan is approved by the quality department it can be implemented.

After qualification of equipment change control can be implemented so that qualified status is maintained

If change control is initiated before qualification then it can be easily regulated and can proceed without formality and involvement of quality department

Emergency cases should be defined by the organization and the change request can be formalized after replacement

Related document

http://apic.cefic.org/pub/guideline%20technical%20change%20control%20.doc.pdf

Procedure, change control, process owner, quality department, critical change