KIRAN's DIARY: September 2019

In any organization change in the system, process and procedures is natural as part of continuous improvements.

A formal change management (change control) system should be established as an integral part of a Quality Management System (QMS) of the organization to ensure that all the changes are appropriately identified, planned, documented, evaluated, approved & regulated.

There should be written procedures in place for technical & scientific evaluation and potential impact of the proposed changes on the quality of the medicinal products and other possibly affected systems.

Any proposals for GMP relevant changes should be drafted, reviewed, and approved by the appropriate organizational units, and by the quality unit(s).

Assign personnel responsible for initiation, review and approval of the specific steps of the change. It needs to be noted that a change proposal may be expanded, modified or rejected, based on the evaluation performed during the approval process.

There should be traceable system for change log like identification code or number can be assigned.

Following steps could be considered during the process of change control.

1. Change Proposal / Change Initiation
2. Change review
3. Change classification & Approval
4. Change Implementation plan & Implementation
5. Review the implemented change
6. Effectiveness verification & Closure

1. Change Proposal / Change Initiation:

The respective personnel from the department initiate the change proposal by detailing proposed procedure/ process/ system against to the current procedure/ process/ system.
Following should be part of change proposal

¾ Change related to (documents/ Facility/ process/ equipment/ software/ product…etc)

¾ Current system

¾ Proposed system

¾ Reason for the proposed change

¾ Risk of the proposed change

¾ Impacted documents/ systems/ process...etc

There should be proper reason or justification with documented evidence for the proposed change
The risk of the each proposed change to be evaluated in a systematic way. The risk of changes like new facility establishment, new product introduction, process equipment modification/ replacement, change in manufacturing process, change in the API source, lab application software up gradation…etc shall be assessed in a formalized manner by using risk assessment techniques like FMEA.
Few companies has a practice of change classification (Minor/ Major/ Critical) at this stage by change initiator, but as per me it should be at change approval stage by QA as defined in the respective section.
Few companies has a practice of providing anticipated date of change implementation at this stage but as per me it should be after change approval as defined in respective section.

2. Change review:

The proposed change shall be reviewed by all concerned personnel for adequacy.
Starting from change initiator department head followed by related cross-functional department representatives and finally QA shall review the proposed change as part evaluation.
QA holds the responsibility to identify the Cross-functional department representatives (i.e functional subject matter experts) that are required to evaluate the proposed change based on the type of proposed change.
It is better to have provision in your change control SOP that states common proposed changes and required cross-functional departments as part of review process
Finally QA designee hold specific responsibility to evaluate and assess the proposed change to identify all impacted systems/ processes /procedures w.r.t following but not limited to

¾ SOP’s

¾ Specifications/ STP

¾ MFR (Master formulae record), BMR (Batch manufacturing record), BPR (Batch packing records)

¾ Site master file & Validation master plan

¾ Qualification /Validation

¾ Drawing/ Layouts

¾ Stability studies

¾ Approved vendors/ testing laboratories

¾ Trainings

As a part of the evaluation process, the need to obtain approval from or to notify the change to authorities and/or customers, must be evaluated.
The potential for critical changes to affect established retest or expiry dates should be evaluated. If necessary, samples of the medicinal products produced by the modified process can be placed on an accelerated stability program and/or can be added to the stability monitoring program.
Current dosage form manufacturers should be notified of changes from established production and process control procedures that can impact the quality of the API.

3. Change classification & Approval

Finally QA head evaluate change proposal and classify the change and approve the same.
Changes can be classified (e.g. as minor/ major/ critical) depending on the nature and extent of the changes, and the effects of these changes may impart on the process. A classification procedure may help in determining the extent of document review, testing, validation and documentation needed in line with the proposed change.
The classification should be based on sound justification based on the risk to product quality.

Minor : Do not have any impact on product quality attributes

Major : Likely to have indirect minor impact on product quality attributes

Critical: Have significant impact on product quality attributes.

4. Change Implementation plan & Implementation

After the approval of change control by QA Head, the change implementation plan shall be made.
The change implementation plan should contain following as a minimum criteria.

¾ Number changes to be done

¾ Responsible persons for each change

¾ Anticipated completion date for each change

As per the change implementation plan, all the proposed changes shall be done with the anticipated dates if not extension to the anticipated dates can be taken with proper justification.
When implementing approved changes, measures should be taken to ensure that all documents affected by the changes are revised.
After the change has been implemented, there should be an evaluation of the first batches produced or tested under the change.
After completion implementation of all changes, the change initiator notifies QA for further verification and closure.

5. Review of the implemented change

QA verifies each implementation against proposal.
If found satisfactory, assess the requirement for effectiveness verification after certain period of time (after one month, two months, three months. Etc).
If effectiveness verification not required, change control shall be closed.
If effectiveness verification is required the verification plan shall be made.

6. Effectiveness verification & Closure

As per the effectiveness verification plan, QA designee verifies the effectiveness of implemented changes and if found satisfactory and close the change control.

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