In pharmaceutical industry, any change is being made in any process or procedure that might affect the validate system or procedure it is called change control and it is to be approved by the qualified persons.


What is change control in pharma?

Annex15 of the EU GMP Guidelines defines change control as: 

“A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. 

The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state."


Handling of change control

Regarding the handling of change control, Chapter 5.23 of the EU GMP Guidelines states the following:

"Significant amendments to the manufacturing process, including any change in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated."


CFR provides brief notes on the topic of "change control":

§ 211.100 Written procedures; deviations: (a) "There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 

These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit."


§ 211.160 General requirements. (a) "The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit”.


As change control covers a wide area of application, it is the task of the entire company.


"Written procedures should be in place to describe the actions to be taken if a change is proposed to a product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or support system operation”.


Reference:  PIC/S document PI 006, section 6.7.1.


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