Change Control Case Study

Change:- Change refers to any modification in equipment , manufacturing materials, facilities,

utilities, design, formulations, processes, packaging/ labeling, computer system, and all
associated documentation.

Change Control:- Change control is a systematic approach to managing all changes made to a
product or system.

Table-1: Categories with examples of change control

1. Specification Changes in any specification Bill of Material (BOM) or data sets.

Changes This may include:
 Raw materials, packaging component. In process testing. Packaged
product & equipment specifications
 BOM for bulk & finished products
 Data sets for starting materials or finished products
2 Analytical Any change to or deletion of a testing procedure or inclusion of a reduced
method testing schedule. This include but not limited to:
change  Raw materials, packaging components in process products &
calibration tests
3 Raw Materials Any change to raw material supplier manufacturing site, manufacturing
Change process, mode of transport or storage of containers

4 Packaging Any change other than artwork to a packaging component. This includes but
Components is not limited to:
 Bottles, caps, tubes, foils etc. (thickness, material dimensions)

5 Manufacturing Any change to the processing procedure. This includes but is not limited to:
Process  Manufacturing process (e.g. stirring time, blending, order of addition
Change drying time or temperature where variation is not specifically
covered in the manufacturing instructions)
 Packaging process (e.g. cap torque, filling temperature, line set up &
shut down procedure, fill volume, blister seal temperature etc.)
 Cleaning process (e.g. time, temperature method, cleaning agents,
HVAC Systems, etc.)
 Transfer of an in-house manufactured product to an alternate
manufacturing site.
 Introduction of a new product to the manufacturing facility.
6 Equipment/ Any modification or alternation to equipment or the environment where the
computer equipment operates, or the relocation of the equipment from one place to
change another or the introduction of a new equipment or consumables to existing
equipment. This is not limited to:
 Manufacturing equipment (e.g. manufacturing & storage tanks,
blender, stirrer, compressing machine, drying ovens, granulators,
fluid bed dryers, storage hoppers, transfer lines etc.)
 Purified water system (e.g. pumps, valves, dosing mechanism etc.)
 Packaging equipment (vision system, capper, labelling machine,
bottle blower, shrink wrapper, cartonner, case packer etc.
 Testing equipment (e.g. pH meter, viscometer, scales, thermometer,
HPLC, balance, spectrophotometer etc.)
 Environment (e.g. air conditioning, humidity, pest control, lighting
etc.)
 CHANGE CONTROL FORMATE

CHANGE CONTROL NAME OF COMPANY:

Subject: Change control no.
SOP Ref No.
Initiated by: (Department) Page No.
Date:
Present status:

Proposed change:
(Including nature of change, e.g. process, documentation, procedure, etc.)

Reasons:

Department head
Signature/date
Assessment/evaluation of change, expected impact on product quality

Quality head Department head

Signature/date Signature/date
Comments of technical head (if required)

Technical head
Signature/date
Implementation details:

Implemented on: Department head

Signature/date
Validation details (Validation report no.)
Quality head Department head
Signature/date Signature/date

Completion
1. Implementation Yes / No
2. Documentation of evaluation, revision, etc. Yes / No
3. Retrieval of obsolete documents Yes / No
Quality head Department Technical head
Signature/date head Signature/date
Signature/date
Technical head
Signature/d