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SOP for Change Control in Pharmaceuticals

Purpose:
To lay down a procedure to define the mechanism for the initiate, 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:
Designee of 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 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 of safety, health and environmental aspects. Some of the major and minor changes are listed below:
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 formulation manufacturing process.
  4. Changes in the quality of raw material(s) or key intermediate(s) used in the formulation manufacturing process.
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's etc.


  • The Initiating department shall forward the proposal as per the requirement to Formulation & Development Department for comments and clearance.
  • After giving comments/clearance, Formulation & Development shall forward the change control form to Quality assurance department.
  • 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/ 20.
CC = Change control code.
001= Sequential Change control Number (001, 002, 003…………..999). 
20= Current year 2020 (Last two digit of current year)
  • QA shall enter the details of 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 customer or any updation in dossiers etc. and forward the change to Site Quality Head.
  • Site Quality Head shall receive the comment form all the concerns and takes the decision of approving or rejecting the change.
  • On completion of the total procedure, QA shall formally enter the status in Change control Register and close the Change control Procedure.
  • Put the stamp of ‘OBSOLATE COPY’ on the old documents, where every this change control
  • 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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