Definition of Change control in Pharmaceutical industry -Basic

   Definition:

   Change in established system through the documentation procedure This system is known as change control procedure. 

Basic of change control Procedure:

   - Change control is most important tools or documentation in Pharmaceutical industry

   - It may be the addition, removal or Modification of equipment /instruments or Process ,any change in documents Facilities or system.
- If any change in manufacturing facility or process or in document that have  potential to impact  the safety, quality, purity, efficacy or potency. It must be in a way that assures these characteristic are not adversely impacted and it should be documented properly.
- change control should be formerly requested, Documented and approved before implementation.
- Record should be maintained properly.
-  Concern department personnel responsible to raise the change control and implementation of changes after approval.
-QA department is responsible to evaluate, approval and verification of changes. 

Classification of Change control:
-Changes can be classified as following category based on the impact on quality.
1.Minor 
2.Major
3.Critical

Now A days concept of temporary change control and permanent change control are in used in pharmaceutical industry.

Related Post:
Change control management in Pharma
Classification of change control in Pharma  
Deviation in Pharmaceutical Industry