What is Change Control

Make changes through change control systems in production, quality control, quality assurance, stores, engineering and R&D departments.

The role of change control is very important in Pharmaceutical industry. Any changes in Pharmaceutical industry is make by change control procedure.

when a change make in Pharmaceutical industry in any process or procedures it is change by change control SOP or change control procedure. change control is used to evaluate the impact of changes in Pharmaceutical industry.

Following are the changes which are to be make by change control process: 

• Change in hold time of drug product at any stage.

• Change in storage condition like temperature and Reletive humidity.

• Any changes in stability protocols like sample quantity, sampling procedure, additional sample etc.

• Change in in-process procedure.

• Change in manufacturing process.

• Change in storage container.

• Change any parameters in machine.