SOP on Change Control

Table of Contents

Mastering Change Control in the Pharmaceutical Industry: A Guide to Quality and Compliance

Navigate the intricacies of change control with this comprehensive guide!

Ensuring the safety, efficacy, and quality of pharmaceutical products hinges on meticulous control over changes. This SOP dives into the essential steps and considerations for implementing an effective change control system in your facility.

Understanding the Types of Change Control:

  • Document Change Control (DC): Modifying approved documents like Master Batch Records, Standard Operating Procedures, and Validation Protocols.
  • Facility/Engineering Change Control (FC): Planned modifications, maintenance,or inclusion/removal of equipment, utilities, or facilities.

Initiating the Change Control Process:

  1. Identify the change and its reason: Clearly define the proposed change and its justification.
  2. Fill out the change control form: Obtain the form from Quality Assurance and provide details like scope, impact analysis, and existing vs. proposed systems.
  3. Departmental review and recommendation: The initiator’s department reviews the form and adds recommendations.

Approval and Impact Analysis:

  1. Quality Assurance assessment: QA reviews the form, suggests additional actions, and seeks comments from affected departments.
  2. Management review and comments: Plant Manager and QA review the form and provide their comments.
  3. Impact analysis: Analyze the change’s potential impact on product, process,stability, regulations, and other aspects.
  4. Categorization: Assign a category (“Critical,” “Major,” or “Minor”) based on the potential impact.

Implementing and Executing the Change:

  1. Compliance with recommendations: Ensure all recommendations are fulfilled before implementation.
  2. Implementation date: QA assigns the implementation date after receiving compliance reports.
  3. Responsibility and monitoring: The initiator and impacted departments are responsible for implementation and recommendation compliance.
  4. Quality Assurance review: QA reviews the risk analysis and the change control’s closure.

Change Control Numbering System:

The 12-digit system categorizes changes by department, type, sequential number, year, and last two digits of the year.

Documentation Approach:

The change control form includes specific sections for subject, scope, reason, existing & proposed systems, impact analysis, implementation date, closure date, and attachments.

Life Cycle of Change Control:

The change control goes through various stages from initiation to closure, with defined timeframes for each step.

Additional Key Points:

  • Quarterly review meetings for change control progress.
  • Yearly summary of all change controls.
  • Product-specific change control listing in APQRs.
  • Document retention as per SOP for destruction and storage.

By adhering to this SOP and understanding the complexities of change control, pharmaceutical companies can ensure compliance, product quality, and patient safety.

Remember, this is just a summary. For complete details and implementation guidelines, refer to the original SOP.

The purpose of this SOP is to lay down a procedure to “Change Control” to ensure that the proposed changes shall not affect the strength, identity, safety, purity and quality of the product.




        • Initiation of a document or modification of approved documents including but not limited to Master Batch Records (MFR/ BMR/ BPR), standard Operating specifications, Method of Analysis, format / Labels, Qualification / Validation Protocols, Stability Protocol, Validation Master Plan, Policies and Guidelines, Site Master File, Change in manufacturing process

        • Planned modification, Major maintenance, removal / decommissioning and inclusion of equipments, utility, facility / building.
        • The Department, by whom the change / modification is initiated, shall first request for change control form from QA and fill up the change control form with brief details of the change and the reason for the same with proper justification.
        • Quality Assurance shall issue a change control form & allocate a change control number according to the nature of change requested.  the numbering system described in this SOP and shall note the number in the change control log.
        • The initiator shall then complete the change control form in all respect elaborating the scope / justification of the change in consultation with concern other department(s) as appropriate the details of these documentation have been describe in the documentation approach  of this SOP.
        • The existing system and the proposed change shall be briefed in the specified sections of the change control (separate sheets can be used, if necessary).
        • The initiator shall also perform the impact analysis in co-ordination with other concern Department(s) and write the recommendation if any as specified in the section of change control form.
        • The Manager of the initiator department should review the change control form and the impact analysis and add any recommendation for a limited number of months based on prior approval of QA. The implementations of preceding years shall also be reviewed in the current APQR.
        • The department Manager is to sign of the change control form and forward it to Quality Assurance for review.
        • Quality Assurance should recommend/ any additional actions if necessary and identify the requirement for comments of other affected department with consultation of Manager Change control then shall forward to other affected department for their comments (Whenever required).
        • If required comments of any department which is available outside the plant including Corporate Quality (CQA), change control shall be forwarded to respective department through scan copy / hard copy / any other communication mode. Signed scan copy should be attached with change control (where required).
        • Change control shall be forward to plant Manager for his / her review and comments.
        • QA shall take the comments of customer / contract giver on respective column of change control form (Whenever required) through scan copy / hard copy / any other communication mode. Signed scan copy should be attached with change control (Whenever required).
        •  QA  shall review the completion status of initiation, impact analysis, comments of other responsible personnel and will sign as reviewed by the change control form and completely filled change control shall forward to Manager – QA / Designee for Approval / Rejection of change control.
        • When the change control is raised for new product / process / equipment impacts on the cleaning validation, process validation and analytical method validation shall be analyzed specifically along with the impact on other Manager ings.
        • The Manager -QA / designee shall review the impact analysis and approve / Reject the change control with addition / deletion of recommendations as appropriate.
        • The Manager -QA / designee shall tick on the Category (Critical, Major & minor) and Approved / Rejected status.
        •  QA  write NA wherever Not Applicable after approval of change control.
        • The Manager -QA / designee shall assess the change(s) and assign the category as follows:

Category “X” – All Minor Changes which are not classified as major.

# Change in non – critical equipment, which will not affect the quality of finished product.

# Any other change that will not affect the registration material and the Quality of     finished product.

Category “Y” – All major changes having effect on the following

#  Registration material (registration application, including supplements etc.

#  Manufacturing process affecting the quality of finished product.

# Control methods and limits used as the basis for release, which is not affecting the quality of the product.

# Product specification, which has been submitted to the authorities.

# Changes in stability specification.

# Changes in the shelf life of finished product.

# Changes in document, which will affect the registration material.

# Change in solvent used for drug product manufacturing

Category “Z” – All Critical Changes are likely to have an impact on the critical process, procedure, product or system and document. These changes are evaluated against the current commitments and requirement which is directly affect the quality of the product.

  • All the recommendations shall be endorsed by the impacted department Manager s and shall be responsible for compliance of the recommendations.

  • The change control form should be submitted to quality Assurance Department within 7 working days from the issue of the change control number, otherwise the change control issuance shall be cancelled and the change control number shall be invalid

    • The date of implementation of the change / initiation of modification shall be assigned by Quality Assurance after receipt of the compliance reports of the recommendations that are to be complied before the implementation / execution.
    • All the recommendation that are to be complied before the implementation of the change / initiation of modification shall be complied before the implementation /execution initiation date.
    • The change shall be implemented from the implementation date mentioned on the Change control form.
    • All the recommendations of the change control shall be taken care of during and after change / modification. The initiator department and the impacted departments shall be responsible for the implementation / execution of the change and compliance of all the recommendations.
    • Manager Quality Assurance will review the Risk Analysis as appropriate.
    • After compliance of all the recommendations, Quality Assurance department will review the closure of the change control and get the closure approved from the Manager Quality Assurance.
  • CHANGE CONTROL NUMBERING SYSTEM: The change control number should have the 12 digit following details:
    • The change control number consists of following characters format as described below.
    • (——-) ()         (——–)             ()        (——–)           ()         (        )

Dept. Code   Slash Type of   Change Slash   Sequential No. Slash Year of Change.

The first sections (Two characters) are alphabets and are the department codes.

The third character is Dash “

The second sections (4th & 5th characters) are alphabets which indicate the type of change e.g. DC for document change request,

FCR for facility / engineering / area change request,

SCR for system related change request.

Next Sixth character is slash “

Next section (7th, 8th & 9th characters) are numeric indicating the change control number in the current calendar year, which will start from 001 for each functional department.

Next tenth character is slash “

Last two (11th & 12th characters) are numeric representing the last two digits of the current calendar year.

e.g.: QA-DC-001-23 indicates the First change control for Document

Change given in year 2023 for Quality assurance dept.


    • Change control form shall have the change control number dully allotted by QA and received by initiator department, which is responsible for the movement of change control document for subsequent approval.
    • Change control form shall have the following sections as a part of initiation of a proposed change.
    • SUBJECT: This section should describe the details about the change in which documents / facility / procedure change is required. For Example: To revise document Number AAA, Title: BBB.
    • SCOPE: This section should describe the department / equipment / document / process name / along with the scope of change i.e. briefly what the change is about. For Example: To revise document Number AAA, Title: BBB to incorporate test from current pharmacopoeia.
    • REASON FOR CHANGE: In this section the reason / trigger for which the change is required will be elaborated. This section shall explain why this change is proposed at the moment. It may include but will not be limited to, the implication for some other changes, GMP requirements / change in regulations, addition deletion of equipments, adoption of new process / test method / protocols, gap analysis during scheduled revision etc.
      • In this section the existing process / facility / procedures in the documents that are to be changed will be written briefly.
      • In this section the changes proposed correlating with the existing system, document should be written.
      • In this section the impacts on different aspects like Product, Process, Stability Regulatory, Validation / Qualification, Training, Packaging material, documents or any other parameters / aspects should be analyzed on a centralized approach not confining to the particular system / documents which is under change.
      • Impact on specifications
      • Impact on related documents or Standard Operating Procedures.
    • Change control form shall have the date of implementation of change.
    • Change control shall have a date of its final closure along with compliance of all recommendations thereof.
    • All the attachments to a change control should be numbered and addressed / approved properly.
    • Change control format should be completely filled and signed by concerned personnel and then approved by Manager -QA / Designee before execution and Implementation of change.
    • The day the change control is initiated after obtaining a number from QA until the day it is submitted to QA for review, the change control will be considered as dormant.
    • From the day the change control is reviewed by QA and the day it is approved, it will be considered under impact analysis.
    • This cycle from issuance to approval should not exceed 07 working days, failing which the issuance of change control shall be cancelled and the change control shall be invalidated
    • The day change control is approved and recommendations are duly endorsed by the impacted department Manager s, the change control will be considered as approved but not implemented. However the preparatory work for the implementation can be initiated.
    • The change control status will be considered open after the implementation of change until the compliance of the recommendations. This phase of change control will be crucial as failure to comply with any of the recommendations may result in retraction of the change.
    • If recommendation mentioned in the approved change control not implemented / No action taken against the approved change control within one year from the date of approval of change control, then change control shall be treated as cancelled and new change control shall be fill whenever required.
    • The change control will be closed only after compliance of all recommendations and approval by the Manager – Quality Assurance.
    • The closure of change control should be ideally within 30 days from the approval date of change control. If not closed within 30 working day’s initiator department has to submit justification to QA.
    • A log for the change control shall be maintained as per Format for the         keeping the change controls.
    • Quarterly Review meeting for change control shall be held by Manager – QA with Change Control Committee Member to review the progress or closure of change controls.
    • Quality Assurance shall prepare summary of all the change controls on yearly basis, as per Calendar year – From January to December
    • Product specific change control shall be listed in APQR.
    • Change control shall be preserved according to SOP for destruction & storage of documents.

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