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Change Control in Pharmaceuticals


Learn how to do Identification of changes in Facility, Manufacturing Process, Specifications & Documentation and evaluation and implementation of change control.

1.0  Identification of changes

1.1  Facility : 

It includes changes in building design, lay out, addition or deletion, shifting or replacement of equipment, change in the water system, {generation unit, distribution system, storage facility,} AHU/HVAC and any other utility system {Such as air, nitrogen, hot water, cold water, steam etc.} which may directly or indirectly affect the manufacturing process/quality of the product.

1.2  Manufacturing Process : 

It includes change in Batch Size, Master Formula, i.e,. raw materials quantity, Batch manufacturing process/Packing Method, process parameters and in-process control.

1.3  Specifications : 

Change in specifications of RM/PM {including  active, exepients, solvent, reagent etc.}. In-process materials, intermediate, finished product and any other material that directly or indirectly affect the product quality.

1.4  Test Procedure : 

Analytical or Microbiological test procedure, stability program.
1.5  Documentation : Batch Manufacturing Record, formats, Validation Protocol, Validation Master Plan, Site Master File and other formats.
1.6. Procedure and formats related to engineering, instruments.

2.0  Details of Change : 

Change of facility {building, equipment, utility, instrument, system} should be clear in terms of modification, modification, replacement, re-installation or new installation. Location of the equipment/utility, instrument should bear the floor level and name of the room, specific purpose of the equipment/utility/instrument should be described. If appropriate change should be described through drawing of existing and proposed, Process change, except the change in standard batch size, clear distinction between existing process and proposed process should be given.
Change in specification or method of analysis should mention the compondial changes, instrument change or change in stability program.

3.0  Reason for Change : 

Reason should be specific. The cost and /or quality benefits should be fulfilled.
4.0 Give the list of documents, which will get affected due to proposed change.
5.0 Give the tentative date of implementation of change and procedure name if applicable.
6.0 Write the name and sign. In the ‘Prepared By’ Department Head will check and then write his name along with signature in the change request form.
7.0 Evaluation by QA: Receive the change control format check the format for its completeness.
8.0 Evaluate the action applicable to be carried out before implementation of the proposed change.
9.0 Implementation: Based on the evaluation as above, the proposal is finally approved/rejected by Plant head and QA Head.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


6 Comments so far : Add yours...

faisal said...

very good information thanks

dandurisreenivasulu said...

VERY GOOD INFORMATION ALL SOPS ARE ARRANGED IN PDF FORMAT PLEASES

Neelesh Mathur said...

Thnx for good information.

jhsancle said...

Excellent information for industry, students and professional

Nasim Faridi said...

great thanks for your useful information for industry

Unknown said...

A VALUABLE AND RELIABLE INFORMATION....THANKS ALOT...

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