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Change Control in Pharmaceutical Industry

Change control is a process used in the pharmaceutical industry to report and approve any changes made to processes, procedures, equipment, or materials. It helps control and document all changes to ensure quality and compliance. Any modifications to production, engineering, research and development, materials, quality control, quality assurance, information technology, or cleaning procedures must be reported through change control and authorized by management.

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Dharmesh Patel
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335 views2 pages

Change Control in Pharmaceutical Industry

Change control is a process used in the pharmaceutical industry to report and approve any changes made to processes, procedures, equipment, or materials. It helps control and document all changes to ensure quality and compliance. Any modifications to production, engineering, research and development, materials, quality control, quality assurance, information technology, or cleaning procedures must be reported through change control and authorized by management.

Uploaded by

Dharmesh Patel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

What is change control ?

In pharmaceutical industries change control has an important role. In pharmaceutical every


change is reported by change control process.

When a change is being made in any process or procedure it is reported by change control and
that is approved by the company authority. Change control is used to control the changes made
in pharmceutical industry.

Following are the changes which are to be reported by change control:

a. Production
       Change in Location.
       Change in Equipment.
       Critical Process control parameters.
       Change in Batch size.
b. Engineering
       Change in any equipment.
       Critical Part of any equipment.
       Facility, Design layout.
       Utility (any change in Water System / HVAC System).
c. Research & Development
       Change in Specifications of Raw Material/Packaging Material/Finished product.
       Addition / Deletion of any Raw material in the product.
       Change in quantity of Raw material in the product.
       Addition / Deletion of any manufacturing Steps.
       Change in Shelf Life.
       Change in Environmental Conditions.
       Change in Specifications of Inprocess / Intermediate materials.
       Change in Storage conditions.
       Change in method of analysis or change in sampling plans and method.
       Change in Hardware / Software of any Computerized Analytical Instruments.
       Change in Stability Protocols.
d. Materials (Raw & Packaging Material)
       Change in source of any Raw Material or primary packaging material.
e. Quality Control
       Change in method of analysis or change in sampling plans and method.
       Change in Hardware / Software of any Computerized Analytical Instruments.
       Change in Stability Protocols.
       Change in specifications of Raw Material / Packaging Material / Finished product.
       Change in Specifications of In Process / Intermediate Materials.
f. Quality Assurance
       Change in Sampling Plan/Quantity of Samples.
       Change in Documents and SOPs.
       Change in Validation Protocols.
g. Information Technology
       Change in Hardware / Software.
h. Cleaning Procedure
       Change in cleaning steps.
       Change in cleaning aids.
       Change in cleaning agents.

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