What is change control?

In pharmaceutical industries change control has an important role. In pharmaceuticals, every change is reported by the change control process.

Change control is a systematic approach to managing all changes made to a product or system. The purpose is to ensure that no unnecessary changes are made, that all changes are documented, that services are not unnecessarily disrupted and that resources are used efficiently.

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

A change control document has to be a systematic and sequential entry of data supporting change in a project. It goes through an initial process of change request, through the process of change approval or denial and finally with change implementation, if it is approved.

Following are the changes which are to be reported by the change management process:

A. Production

Change in location
Change in equipment
Critical Process control parameters
Change in batch size.

B. Engineering

Change in any equipment
Critical parts of any equipment
Facility, Design layout

C. Research and Development

Change in specifications of raw material/packaging material/finished product
Addition/deletion of any raw material in the product
Change in the 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 In-process/ intermediate materials
Change in storage conditions
Change in the method of analysis or change in sampling plans and methods.
Change in hardware/ software of any computerized analytical instruments
Change in stability protocols

D. Materials (Raw and Packaging material)

Change in the source of any raw material or primary packaging material

E. Quality Control

Change in the 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. Packaging Development

Change in artworks

H. Information Technology

Change in hardware/ software

I. Cleaning Procedure

Change in cleaning steps
Change in cleaning aids
Change in cleaning agents

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