QUALITY MANAGEMNT SYSTEMS: Change Control (CC)

Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.

Introduction to Change Control.

Definition of Change Control.

Function of Change Control.

Area of Change.

Written Procedures and Documentation.

1. B.PHARM. VII-SEMESTER
BP 702 T.
INDUSTRIAL PHARMACY-II (Theory)
Q
U
A
L
I
T

2. QUALITY MANAGEMENT SYSTEMS
Dr. Ajay K. , Maharishi Arvind College of Pharmacy, Jaipur

3. TREY
research
CHA
NGE
CO
NTR
OL
LEARNING OBJECTIVES
After completing this presentation, you will be able to understand:
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
3

4. TREY
research
4
CHANGE CONTROL

5. TREY
research
5
CHANGE CONTROL
In pharmaceutical industry
change control is an important part of quality assurance.
The changes proposed and made in any procedure or
process should be
reviewed, established, documentedand approvedby
the concerned authorities.
Change control is the system
to implement this approved change
to confirmthe regulatory requirements.

6. TREY
research
6
CHANGE CONTROL:
Definition
Change control can be defined as;
“A formal system by which qualified representatives of
appropriate disciplines reviewproposed or actual changes
that might affectthe validated status of -
facilities,
systems,
equipment or
processes.
The intentis to determine the need for action that would
ensureand documentthat the system is maintained in a
validated state”.
(EU GMP Guidelines, Annexure 15)

7. TREY
research
7
CHANGE CONTROL:
Function
Any change in manufacturing process, equipment, materials
used that may cause alteration in product quality should be
validated.
The main functions of change control are:
1. Identificationof the changes made.
2. Reviewof the change.
3. Approvalof the change.
4. Validatingthe changes which can alter the product quality,
regulatory or GMP requirements.
5. Analysisof the change and monitoring of the impact of
change.

8. TREY
research
8
CHANGE CONTROL:
Area of Change
1.Manufacture:
Following changes are concerned:
• Raw materials
• Equipments
• Process/parameters
• Testing/validation procedures
• Packaging materials
• Cleaning process

9. TREY
research
9
CHANGE CONTROL:
Area of Change
2. Quality control and quality assurance:
Following changes are considered:
• Quality testing parameters
• Sampling size
• Validation process
• Specifications of
raw materials, intermediatesand final product
• Documentation
• Standard operating procedures (SOPs)

10. TREY
research
10
CHANGE CONTROL:
Area of Change
3. Research and development:
It includes the change in;
• Manufacturing process
(any additionOR eliminationof steps)
• Raw materials
(any additionOR omissionof the product)
• Specifications of
raw materials, intermediatesand final product
• Quantitative aspects of
raw materials and finished products
• Manufacturing conditionsand storage conditions
• Testing/validation procedures

11. TREY
research
11
CHANGE CONTROL:
Area of Change
4. Engineering:
It includes the following changes in:
• Equipmentused
• Validationof the equipment
• Partsof equipment
• Workingand design layout
• Software/ Hardwareor Change in any program
5. Marketing.

12. TREY
research
12
CHANGE CONTROL:
Written Procedures and
Documentation
Procedures in writing
should be kept at the proper place
to describe the changes made related to
the materials, equipment and
method of manufacturing or testing conditions or
any other change that can affect the quality of the
product.
Standard operating procedure (SOP) and records of
change control documentsare required for the
documentation.

13. TREY
research
13
CHANGE CONTROL:
Written Procedures and
Documentation
Change Control Form (CCF)
is an important documentation part of change control.
It contains the form related to initiate department for
the proposed change,
proposed change details,
comments from QA Head, category of the changes,
supportive documents,
management review form and
assessment of CCF.

14. TREY
research
14
CHANGE CONTROL:
Written Procedures and
Documentation
Change Control Form (CCF)

15. TREY
research
15
CHANGE CONTROL

16. B.PHARM. VII-SEMESTER BP 702 T. INDUSTRIAL PHARMACY-II (Theory)
DR. AJAY K. TIWARI, ASSOCIATE PROFESSOR
MAHARISHI ARVIND COLLEGE OF PHARMACY, JAIPUR (RAJ.)
[email protected] WHATSAPP: [phone]
To be continued...