What is Change Control process in pharma?

What Is Change Control process In Pharma?

Change control is one of the change management processes in pharmaceuticals. Whenever it needs to change in the procedure or practice or process change control is necessary to address the activity.

Change control is a formal process to implement the new change in the existing system in a justified way by an authorized representative.

Change Control Process in pharma as per 21 CFR

As per 21 CFR there are two notes on topic of “change control”, (21 CFR, 211.100 and 21 CFR, 211.160)

§ 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. Such procedures shall include all requirements in this
subpart. 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. The requirements in this subpart shall
be followed and shall be documented at the time of performance. Any deviation from the
written specifications, standards, sampling plans, test procedures, or other laboratory
control mechanisms shall be recorded and justified.”

Change Control Process in pharma As Per EU GMP Annex 15 guideline

Annex 15 EU GMP Guidelines defines the Change control;

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.

Chapter 5.23 of the EU GMP guidelines says that, this is about the handlings of changes:

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

Also Read:

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Change Control Process in pharma As Per PIC/s

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) document PI 006-2.


“Written procedures should be in place to describe the actions to be taken if a change
is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect
Pharma Change Control: Strategies for Successful Company-Wide Implementation 5
product quality or reproducibility of the process. Change control procedures should ensure that sufficient supporting data are generated to demonstrate that the revised process
will result in a product of the desired quality, consistent with the approved specifications.
“(Annex 15, no. 43)


“Change control is an important element in any Quality Assurance system. 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.” (PIC/S document PI 006, section 6.7.1)

Change control process in pharma is the term for the record, maintain, and store the evidence of changes done in the system on time to time or as per regulatory requirement.

Change can be done for simplification or for any specific requirement or as an when any revision in the existing procedure.

In order to follow the Current Good Manufacturing Practices (cGMP), it is important to make a record of any changes made in the procedure. Change control is a documented evidence of that changes made in the procedure. The change management system should be in place in every organization in order to make transparency in the change control system.

As per regulatory, it is very important to record all changes, it indicates that the organization has compliance is in place.

change-control-process-in-pharma
Change Control Process In Pharma

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