This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.

1. B.PHARM.VII-SEMESTER
BP702T.
INDUSTRIALPHARMACY-II(Theory)

2. QUALITYMANAGEMENTSYSTEMS
Dr. Ajay K. , Maharishi Arvind College of Pharmacy, Jaipur

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LEARNINGOBJECTIVES
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.
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CHANGE CONTROL

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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, documented and approved by
the concerned authorities.
 Change control is the system
 to implement this approved change
 to confirm the regulatory requirements.

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CHANGE CONTROL:
Definition
Change control can be defined as;
 “A formal system by which qualified representatives of
appropriate disciplines review proposed or actual changes
that might affect the validated status of -
 facilities,
 systems,
 equipment or
 processes.
 The intent is to determine the need for action that would
ensure and document that the system is maintained in a
validated state”.
(EU GMP Guidelines, Annexure 15)

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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. Identification of the changes made.
2. Review of the change.
3. Approval of the change.
4. Validating the changes which can alter the product quality,
regulatory or GMP requirements.
5. Analysis of the change and monitoring of the impact of
change.

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

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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, intermediates and final product
• Documentation
• Standard operating procedures (SOPs)

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CHANGE CONTROL:
Area of Change
3. Research and development:
It includes the change in;
• Manufacturing process
(any addition OR elimination of steps)
• Raw materials
(any addition OR omission of the product)
• Specifications of
raw materials, intermediates and final product
• Quantitative aspects of
raw materials and finished products
• Manufacturing conditions and storage conditions
• Testing/validation procedures

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CHANGE CONTROL:
Area of Change
4. Engineering:
It includes the following changes in:
• Equipment used
• Validation of the equipment
• Parts of equipment
• Working and design layout
• Software/ Hardware or Change in any program
5. Marketing.

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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 documents are required for the
documentation.

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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.

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CHANGE CONTROL:
Written Procedures and
Documentation
Change Control Form (CCF)

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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.)
AJAY81AJAY@GMAIL.COM WHATSAPP: 9782226444
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