What is change control?
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
