SOP for Change Control in Pharmaceuticals

Purpose

To lay down a procedure to define the mechanism for the initiation, review, and authorization of changes in all documents and processes.

Scope

This SOP shall be applicable for the identification, documentation, appropriate review, and approval of changes in raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware) processing steps, labeling and packaging materials, and computer software.

This procedure applies to handle the change control at the facility.

Responsibility

A designee of the Originating Department

Procedure

• The initiating department shall initiate the change as per the change control format no.
• The initiating department shall furnish the details very clearly in the form for the present process/use, proposed change, Justification & impact analysis, and acceptance criteria.
• 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:

1. Major Changes

For a substance of chemical and microbiological quality evaluation.

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

2. Minor Changes

1. Change in the administrative references (name/company name, address) of the certificate holder.
2. Change in the references (name/company name, address) of the manufacturing site.
3. Change or updating of the methods of analysis used to test the substance.
4. Change in the specifications of the substance.
5. Change in supplier of starting and packing material.
6. Change in the batch size.
7. Addition of a new manufacturing site in the same site as described in the original dossier.
8. Change in the documents like SOP etc.

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• The Initiating Department shall forward the proposal as per the requirement to the Formulation & Development Department for comments and clearance.
• After giving comments/clearance, Formulation & Development shall forward the change control form to the Quality assurance department.
• On receipt of the Change control form from the 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.

1. First, two digits represent the change control code.
2. The third, fourth, and fifth digits represent sequential change control No. (001 to 999)
3. The sixth and seventh digit represents the 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/ 23

CC: Change control code.

001: Sequential Change Control Number (001, 002, 003…………..999). 

20: The current year 2023 (Last two digits of the current year)

• QA shall enter the details of the Change in the Change control register.
• QA shall evaluate the feasibility of the change and forward the change control form to Regulatory Affairs if required.
• Regulatory affairs shall evaluate the change in terms of any need to inform the customer or any updation in dossiers etc. and forward the change to the Site Quality Head.
• The site Quality Head shall receive the comments from all the concerns and take the decision of approving or rejecting the change.
• On completion of the total procedure, QA shall formally enter the status in the Change Control Register and close the Change Control Procedure.
• Put the stamp of ‘OBSOLETE COPY’ on the old documents, where every change controls the procedure is applicable.

Annexure

Abbreviations

QA: Quality Assurance

VP: Vice President

SOP: Standard Operating Procedure

F & D: Formulation & Development

Revision History

Nil

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