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Change Control

Assigned personnel. 5.0 Procedure: 5.1 Initiation of Change Request: - Any change required shall be initiated by filling up the change request form. - The form shall be filled up by the initiator giving details of existing and proposed change along with justification. - The initiator shall submit the form to respective department head. 5.2 Review and Approval of Change Request: - The department head shall review the change request and if found appropriate shall forward to change control committee. - The change control committee shall evaluate the change request for its impact, feasibility and regulatory implications. - The committee may approve or reject the change request.

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Change Control

Assigned personnel. 5.0 Procedure: 5.1 Initiation of Change Request: - Any change required shall be initiated by filling up the change request form. - The form shall be filled up by the initiator giving details of existing and proposed change along with justification. - The initiator shall submit the form to respective department head. 5.2 Review and Approval of Change Request: - The department head shall review the change request and if found appropriate shall forward to change control committee. - The change control committee shall evaluate the change request for its impact, feasibility and regulatory implications. - The committee may approve or reject the change request.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Types and Procedure of Change Control

Learn the procedure to handle the Change Control in Pharmaceuticals - Major


Changes and Minor Changes.

1. The initiating department shall initiate the change as per the change control format
no.
2. The initiating department shall furnish the details very clearly in the form for
present process/use, proposed change, Justification & impact analysis and acceptance
criteria.
3. The initiating department shall also define changes as major or minor based on
product quality or its impact on safety, health and environmental aspects. Some of the
major and minor changes are listed below: -

3.1 Major Changes

For a substance of chemical and microbiological quality evaluation.


• Addition or deletion of a step or addition of an alternative/new step in the
formulation manufacturing process.
• Addition of a new manufacturing site with modification of the formulation
manufacturing process described in the original dossier/document.
• Change in input quantities of formulation manufacturing process.
• Changes in the quality of raw material(s) or key intermediate(s) used in the
formulation manufacturing process.

3.2 Minor Changes

• Change in the administrative references (name/company name, address) of the


certificate holder.
• Change in the references (name/company name, address) of the manufacturing site.
• Change or updating of the methods of analysis used to test the substance.
• Change in the specifications of the substance.
• Change in supplier of starting and packing material.
• Change in the batch size.
• Addition of a new manufacturing site in the same site as described in the original
dossier.
• Change in the documents like SOPs etc.
4. The Initiating department shall forward the proposal as per the requirement
to Formulation & Development Department for comments and clearance.
5. After giving comments/clearance, Formulation & Development shall forward the
change control form to Quality assurance department.
6. On receipt of Change control form from F & D department, QA shall assign the
Change control number as per the procedure given below:
Assigning a change control number
- Each change control number contains seven digits.
- First two digits represents change control code.
- Third, fourth and fifth digit represent sequential change control No. (001 to 999)
- Sixth and seventh digit represents last two digits of the current year. (e.g.01, 02,
03…...99).
For example, following change control no is decoded as explained.
CC-001/ 13.
CC = Change control code.
001= Sequential Change control Number (001, 002, 003…………..999).
03= Current year 2013 (Last two digit of current year)
7. QA shall enter the details of Change in the Change control register.
8. QA shall evaluate the feasibility of the change and forward the change control
form to Regulatory affairs, if required.
9. Regulatory affairs shall evaluate the change in terms of any need to inform
customer or any updation in dossiers etc. and forward the change to Site Quality
Head.
10. Site Quality Head shall receive the comment from all the concerns and takes the
decision of approving or rejecting the change.
11. On completion of the total procedure, QA shall formally enter the status in
Change control Register and close the Change control Procedure.
12. Put the stamp of ‘ OBSOLETE COPY’ on the old documents, where every this
change control procedure is applicable.
Change Control Procedure in Pharmaceuticals

By: Pharma Tips | Views: 4394 | Date: 26-Aug-2013


Quality Assurance

Change control is a CGMP concept that focuses on managing change to prevent


unintended consequences. Certain manufacturing changes (i.e changes that alter
specifications, a critical product attribute or bioavailability) require regulatory
filings and prior regulatory approval.Change is an inherent part of the life cycle
of a pharmaceutical product. A change can be an addition to, deletion of, or
modification to manufacturing facility, utilities, process, material, product,
procedures or equipment (including

Change control is a procedure that ensures changes are implemented in a controlled


and coordinated manner. The change control program evaluate all changes that could
affect the production and control of the drug product, intermediate or API. It is the
most critical element in the overall quality management of pharmaceutical industry. A
change control system provides checks and balances in the quality system by tracking,
reviewing and approving the changes. In adequate change control procedures ends up
in regulatory non compliance.

The purpose of change control is to prevent the unintended consequences that are
sometimes encountered when making a change to a product or system.

Benefits of change control system

 Structured and systematic approach for change management with proper


change evaluation
 Documenting & tracking the details of change
 Routing of change requests to appropriate individuals/team for approvals
 Demonstrate compliance to regulatory agencies

Change control Process flow


Changes can happen anytime during a product’s life cycle.

Change proposal

Change Evaluation/review

Change Classification
Identification of impacted
systems/documents & risk assessment

Change Approval

Change implementation

Verification of change implementation

Change control close out

Change control Procedure


A formal change control procedure always begins with a change proposal, which is
initiated by user department personnel with proper justification. The change proposal
then, evaluated by an expert team (change control committee) contributing the
appropriate expertise and knowledge from relevant areas.

After change evaluation, quality unit will classify the change (i.e
minor/major/critical).Benefits of change classification includes

v Classification can help in assessing the impact of change in a reliable way.

v Change classification can be used to identify risk associated with each change
request.

v Change classification can help to determine the change acceptability (i.e reject or
approve changes).

Change classification triggers impact analysis of the proposed change for


identification of impacted systems and documents. There are several risk associated
with each change proposal, including reduced product quality. Risk assessment in
changing requirements of existing systems is an important aspect of producing the
desired result of a change.

After impact analysis and risk reduction, quality unit will approve or reject the change
proposal based on the criticality of the proposed change. The change can be
implemented after change approval by quality unit. After implementation, quality unit
verify the effectiveness of implemented changes, to confirm the change objectives
were achieved and that there was no deleterious impact on product quality. After
verification of change implementation, the change control can be closed.

Change control procedure should ensure that the level of documentation and effort is
matched to the risk associated with the change. It should be ensured that

v The change control is linked to other quality system such as CAPA, customer
complaints, validation etc.

v Includes criteria to evaluate whether changes affects regulatory filings.

v Includes evaluation criteria for determining if changes are technically justified.

GMP deficiencies related to change control


v Inadequate review & approval of the change by quality control unit.

v Failure to file the changes with regulatory.

v Failure to evaluate/justify the changes.

v Excluding "like-for-like" changes from change control program.

Change controls for like to like changes


‘Like to like’ change – replacement of a piece of equipment by another with ideal
characteristics and function.
A pump on a spray dryer system must be managed to control product flow rate to the
dryer. Because the product is sensitive to even minor changes in this rate, the pump is
considered a critical element of the process. The pump recently failed. A new pump of
the same model, same manufacturer and same design was purchased to replace it --- a
like-for-like change. However, the new pump operates more efficiently than the "old"
pump and generates 10% higher RPMs than the old one. Thus, product flow rate (i.e,
injection pressure) is different and results in failing particle size distribution of the
final product.

Let us consider another example of like-for-like change


A company performed a routine replacement of the filling pump pistons, without
taking a change request because it was a “like to like” replacement (which has been a
typical industry practice). Although the replacement pistons had the same part number
as the original pistons, they were slightly longer. This longer dimension caused the
pistons to come into contact with the bottom of the filling blocks, resulting in the
generation of metal particles, which contaminated the product batches.This metal
contamination resulted in the recall of several product batches.
In both the case, a like-for-like change impacted product quality. Thus, even for like-
for like changes, an assessment is needed to determine if pre-use testing,
assessment,qualification or other verification is needed before use. In short, some
truly like-for like changes are innocuous and should be implemented without change
control assessment. BUT, equipment, processes or controls that could impact product
quality should receive additional scrutiny prior to use.

Standard Operating Procedure for Change Control


1.0 Purpose : To provide instruction for change control procedure.

2.0 Objective : To provide a documented procedure for change control procedure.

3.0 Scope : This procedure is applicable for change control procedure.

4.0 Responsibility :
Primary: Officer / Supervisor of respective department.
Overall: Respective department Head.

5.0 Procedure :
• Components of change control
Following changes are including in change control procedure.
Change in the storage condition of raw material, finished goods, WIP.
Change in Expiry or retest date.
Change in Stability study protocol.
Change in SOP.
Change in protocol.
Change in Batch Manufacturing Record.
Change in Batch Packing Record.
Change in Specification and Analytical Test Method of following:
Raw materials and Packaging materials.
In process and Intermediates.
Finished Products.
Change in drawings.
Change in Utilities.
Change in Manufacturing process including rework and re-processing.
In process controls.

• Change Control Procedure.

Any of the changes excluding the changes in specifications, analytical methods,


Master Formula, Batch Manufacturing Records and those changes affecting the
regulatory affairs shall be controlled by the corporate QA.

Any changes at related to GMP requirements but not directly related to manufacturing
or testing process shall be controlled through Ankleshwar QA.

The person requesting the change should fill in the ‘Change Control form’ and submit
it to QA In charge through the department head.

The person requesting the change shall add any reasons or justification with adequate
supporting data for the change to the ‘Change Control form”.

The Q. A In charge shall evaluate the change proposal considering the necessity for
change and any other GMP aspects that will be affected by the proposed change. If
the Q.A In charge has the valid reasons to reject the proposal for change, he / she can
reject the change proposal and intimate the requester about the same.

The Q.A In charge shall verify the proposed change by a number of factors

If required the Q.A In charge shall direct the changes to Corporate QA

If the supporting data is not sufficient, he / she shall direct the requester or any other
related departments e.g. Quality Control to generate the specified information or data.

The Q.A In charge shall approve the change and shall forward the request to corporate
QA for their evaluation & suggestions if required.

If proposed change is in the purview of Corporate QA, The QA In charge shall


forward the change control form with his/ her remark or suggestions to the corporate
QA. QA personnel shall coordinate with corporate QA for the proposed change.
Once the QA department approves the change control form, the user department shall
prepare relevant revised documents.
The revised document shall be approved by QA in charge.
User department shall implement the change, based on effective date mentioned on
the documents.

NOTE: For any proposed change it is necessary to confirm that, the proposed change
will not violet the statutory requirements. If it is require to inform to statutory
authority of the concern country or to the concern buyer, it is necessary to first get
approval from statutory authority of the concern country or from the buyer, than only
proposed change shall be implemented.

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