Failure mode effect criticality analysis FMECA

What is a Change Control in Pharmaceutical Industry?.

How to write a change control?

Change control is a format which is used to manage the change in a pharmaceutical manufacturing company. A pharmaceutical manufacturing company is required to manage the changes through a systematic manner, in order to do so pharma company makes a standard operating procedure to manage the change and provides a format called as change control in the same SOP, this change control format serves as a templet for writing the changes which are required to be done.

The change control format basically consists of following heads.

Name of the Change control: write a short name which clearly identify the change control, it should not be same to any earlier change control.
Originating Department: Who want to do the change, production, packing, Quality assurance, engendering etc.
Change control number: System generated number or manually generated through a documented serial.
Document Number: This is the number of a particular document.
Version number of the change control: This is the number of time a document is changed.
Description of required Change: Description of a change control should clearly specify the nature of change; it should properly have written so that it gives complete information about the change in a short description. While writing this clearly specify the document area and the nature of change to do.
Present procedure, practice: It gives the description of practice that is proposed to change, and how currently the practice is there before the change.
If due the requested change the changes are going on take place on documents, then detail description of the documents and their document number and version number must be written.

Change controls are classified in following categories:

1) Facility.
2) Product.
3) Process.
4) Equipment.
5) Document.

Impact assessment for change control:

The impact of the proposed change on the places documents, process, facility equipment, SOP etc. Quality of the finished product, is required to study, in case of sterile facility and critical area, a supporting risk assessment is also required to do.
Evaluation of impact on all above is studied and documented in the change control format, evaluation is done by originating department and reviewed and approved by Quality assurance.

Which are the heads of impact assessment in change control?

1) Product
2) Product Quality
3) Procedure.
4) Facility.
5) Equipment.
6) Operation.
7) Validation.
8) Analysis.
9) Specifications.
10) MMR
11) MPR
12) Area qualification.
13) Microbial evaluation of the area.
14) VPM
15) Safety
16) Stability
17) Environment.

These are just few examples of heads for which an impact evaluation is required to be done for a change control.
Impact assessment is done by originating dept., and evaluated by quality assurance.
After impact assessment a risk assessment is done to have a ready reference document for possible risks and their mitigation strategy, almost every regulatory agency demand for risk assessment, while it is not a mandatory document but it is important part of guidelines issued by US FDA and rest of regulatory agencies.
Action Plan: Action plan is a very important part of a change control in pharmaceutical industry. It mentions list down the activities which are required to be completed, in sequential manner with the time line for each activity.
According to time line in the action plan all activities must get completed.
For example, making of a Batch Manufacturing record, its time line is 15 days it should be complete within that time line of 15 days.
Validation can be a part of action plan it will take about three months for completing the three validation batches, therefore the time line for completion of three validation batches should be put in the action plan accordingly.
Implementation of Change control: After a change control is approved and after the completion of the relevant action planed in the action plan document, the proposed change is implemented and documented, the first effective batch also recorded with the change.
Closure of Change control: After completion of all actions mentioned in the action plan of the change control, after implementation of the change, proof of the implementation of the change is required to attach with the change control document after evaluation by quality assurance change control is closed.

Time limitation for change control:

Every action in the change control has time limit, after a change control is initiated it must be written as per the SOP, and submitted for review and approval. It should be completed within a week.
Action plans may take time as per the actual time required the time should be mentioned in action plan and then it should be completed within the time mentioned in action plan.

A change control may take longer time as per the nature of the change being implemented, but after a change is implemented the respective documents of implementation of change will have to be attached and the change control is closed in 15 to 30 days after implementation of the changes.
Regulatory aspect of change control:
Almost every regulatory agency across the world demand for change management system, it is a mandatory quality management system

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