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SOP for Change Control in Pharmaceuticals

by KBS.
pharmaceutical products, processes, systems, equipment, facilities, or documentation

A Standard Operating Procedure SOP for Change Control in Pharmaceuticals industry is a critical document that outlines the systematic approach for managing and documenting changes to processes, systems, equipment, facilities, or any other aspect that may impact product quality, safety, or efficacy. The following is a general outline for creating an SOP for Change Control in Pharmaceuticals:

Purpose

To describe procedure for controlling and documenting changes

Scope SOP for Change Control in Pharmaceuticals

The scope of this document pertains to all major and minor changes related to all approved documents, computerized system, utilities, facilities, equipment, instruments and vendors at www.eggpharma.com

Responsibilities

  1. It is the responsibility of QA to prepare, manage and properly implement this SOP.
  2. It is the responsibility of all the employees, planning to introduce change(s) in already approved system follow this SOP as it is written.
  3. QA and initiator of change are responsible to conduct impact assessment of proposed change(s).
  4. QA is responsible to issue change control number, assign responsibilities, assure implementation of change(s) and do follow up as necessary.
  5. QA ensures that this SOP is followed in its entirety.
  6. It is the responsibility of Assistant QA Manager or Designee to review this SOP.
  7. It is the responsibility of QA Head or Designee to approve this SOP.
  8. It is the responsibility of Director Technical to authorize this SOP.

 

Definitions & Abbreviations

  1. Change: Any addition, deletion, or modification to approved documents, products, process, computerized system, utilities, facilities, equipment, instruments and vendors
  2. Change Control: It is a quality management tool to handle, maintain and keep tracking of all major / minor changes. It may be planned activity or forced changes that can be for shorter period of time or it can be permanent
  3. Major change: A change that may have an direct impact upon the product quality, process, safety / procedure
  4. Minor change: A change that may have no direct impact upon the product quality, process, safety / procedure
  5. Document Changes: Any changes on already approved GMP documents
  6. SOP: Standard Operating Procedure
  7. QM: Quality Management
  8. QSM: Quality System Manual
  9. SMF: Site Master File
  10. VMP: Validation Master Plan
  11. CCF: Change Control Form
  12. CC: Change Control
  13. cGMP: Current Good Manufacturing Practices
  14. APIs: Active Pharmaceutical Ingredients
  15. BMR: Batch Manufacturing Record
  16. BPR: Batch Packaging Record
  17. HOD(s): Head of Department(s)
  18. CCC: Change Control Committee

Departmental Codes

  • QA: Quality Assurance
  • QC: Quality Control
  • PR: Production
  • EG: Engineering
  • AD: Administration
  • PU: Procurement
  • AC: Accounts
  • IT:   Information Technology
  • WH: Warehouse
  • RG: Regulatory Affairs
  • RD: Research & Development
  • EX: Export

Procedures SOP for Change Control in Pharmaceuticals

Types of Changes

 There are two categories of changes 

A. Major Changes

Examples are given below;
  • Change of manufacturer of APIs and Excipients.
  • Shifting of processes to another site / place / section.
  • Shifting of equipment(s) to another site / place / section.
  • Major change in the product composition or master formula.
  • Remarkable change in the process parameters.
  • Changes to critical utilities.
  • Changes in the manufacturing equipment.
  • Changes of laundry for work cloth (Sterile).
  • SOP for Change Control in Pharmaceuticals

B. Minor Changes

Examples are given below;
  • Change of cleaning agent for floor
  • Documents changes

Domains for Change Control

Areas that require Change Control but not limited to are as follows;

A. Manufacturing

  • Shifting of whole manufacturing site / section to another site, place or section
  • Major change in equipment
  • Up gradation of equipment(s)
  • Change in critical process control parameters
  • Change in batch size
  • Change in cleaning procedure of equipment
  • Change in cleaning agent
  • Change in environmental conditions

B. Engineering

  • Major change in any equipment
  • Modification in any equipment
  • Change in any critical part of any equipment

C. Facility Design

  • Up gradation of facility design
  • Modification in Air handling unit system

D. Material Management

  • Change in source of any Raw material or Primary packaging material
  • Change in artwork of packaging material

E. Research  Development

  • Change in Shelf Life
  • Change in Specifications
  • Change in Composition
  • Change in Storage Conditions

F. Quality Control

• Change in Hardware / Software or any computerized analytical instruments
• Change in any part of water system design
• Change in water testing method
• Change in testing method of any Raw material or Primary packaging material
SOP for Change Control in Pharmaceuticals

G. Quality Assurance

  • Change in SMF
  • Change in QSM
  • Change in VMP

H. Documentation SOP for Change Control in Pharmaceuticals

  • Change in SOPs, Forms, Templates
  • Change in BMR and BPR
  • Change in Validation / Qualification / Stability Protocols
  • Any change in already approved documents

5.3 Initiation of Change Control (See Annexure A)

  1. Initiator can be user /  controlling department / auditor / regulator or any relevant person
  2. HOD after consultation / recommendation and consensus with initiator, generates Change Control
  3. The HOD / initiator based on justification must submit the Change Control Form (QA/FRM/0000/00) to QA
  4. Initiator fills the form and makes available all documents related to proposed changes and all attachments forwards to HOD
  5. HOD forwards Change Control form to QA for its impact assessment and approval
  6. SOP for Change Control in Pharmaceuticals
Example of Changes are;
Raw material change Any changes to raw material supplier, manufacturer processes, or storage of products
Packaging components Any change to packaging components. This includes but not limited to: Bottles, caps, tubes, foils (thickness, materials dimensions), artwork
Manufacturing process change Any changes to processing procedures. This includes but not limited to: 1. Manufacturing process (stirring time, blending time), order of addition, drying time, or temperature 2. Packaging process (cap torque, filling temperature, fill volume, blister seal temperature) 3. Cleaning process (time, temperature, method, cleaning agent) 4. Introduction of new product into manufacturing facility (if any).
Equipment /computer changes Any modification or alteration to equipment, or the relocation of equipment from one place to another or the introduction of new equipment. This includes but not limited to: 1. Manufacturing equipment (manufacturing and storage tanks, blender, stirrers, compression machines, drying oven, granulation, FBD) 2. Purified water system (pump, valve, dosing machine 3. Packaging equipment (labeller, shrink wrapper,) 4. Testing equipment, scale, HPLC, balance,) pH, viscometer, spectrophotometer) 5. Environmental (air conditioning, temperature, humidity, pest control,

Change Control Numbering and Recording System

  1. QA assigns Change Control No. and records in Change Control Log Book (Annexure B)
  2. The change control numbering system is based on the following format:

CC / DD / YY / 0000

where;
CC: Change Control
DD: Departmental Code
YY: Year
0000: Sequential Number of Change Controls per annum
Example 1: CC / PR / 23 / 0001: The 1st Change Control initiated by Production Department in the year 2023
Example 2: CC / QC / 23 / 0005: The 2nd Change Control initiated by Quality Control Department in the year 2023

Approval and Review of Change Control

  1. QA head reviews the form, reviews all attached documents and planned programs related to changes
  2. QA along with CCC analyze the impact factor and evaluates either changes to be done or not
  3. After decision, QA categorizes the changes and approves as per category
  4. After a successful review, QA approves the Change Control and issues the change control number
  5. After approval, duties are assigned to responsible persons and change is implemented by the relevant department within the target date
  6. In case change control is related to regulatory, prior approval from Director Technical / Operations and QA Head is compulsory

Note 1: No Major change is acceptable unless approved by Director Technical / Operations

Note 2: Mention No. in the form, if change control is on the basis of Complaint No. / CAPA No. / Deviation No. / OOS No.

Evaluation and Implementation SOP for Change Control in Pharmaceuticals

  1. QA Head assigns the effective date of implementation of the changes and the originating department plans for any necessary training and update the relevant documents with corrective actions jointly with QA
  2. The status of change and completion of action is mentioned in the change control form by the originating department along with QA
  3. After evaluation, the documents undergoing for changes / revisions are revised as per the requirement
  4. Upon completion of implemented change, QA follows up on implemented change to determine whether or not actions taken were effective and that the resulting change was communicated to all concerned parties

Note: All changes which can influence on the attributes of a GMP-relevant system, facility, equipment, material / product, and procedure / process should formally be requested by employees. The Change Control Form must be signed by QA Manager

Change Control Committee

  1. On the basis of impact on product quality, regulatory requirements and safety of personnel assessment, the acceptance or rejection of proposed Change is decided by the QA along with CCC
  2. CCC itself can initiate Change Control, in this case it can be directly proceeded by the nominated member, selected by the CCC
  3. Composition of CCC
    • Director Technical / Operations
    • QA Head
    • HOD
    • Initiator of that department
    • HOD of any other relevant department (if required)
  4. Change must be communicated to all the relevant persons and departments through E-mail
  5. CCC organizes meeting either in the presence of Directors or intimates Directors regarding change prior to final decision and implementation

Follow Up and Final Closure

  1. Change control must be close within the target date, if exceeding a proper justification to be presented
  2. Measurement of Change Effectiveness: Assess the measure of effectiveness by performing the followings checks:
    • Monitor periodically to determine the implemented changes were effective
    • Monitor periodically to confirm the problem is resolved
  3. QA assesses the effectiveness of implemented changes periodically to confirm that the problem is resolved and change is productive
  4. Final Closure of Change Control is done by GM QA or Designee And Director Technical / Operations
  5. Change Control documents are archived by QA

Revalidation

  1. Revalidation should be carried out following a change that could have an effect on process, procedures, and quality of products and/or of the product characteristics
  2. Revalidation should be considered as part of change control
  3. Changes that are likely to require revalidation includes following but not limited to:
    • Changes in manufacturing process (e.g. mixing time, drying temperature)
    • Changes in equipment (e.g. addition of automation detection system)
    • Production area and support system changes (e.g. rearrangement of area or a new water treatment methods)

Quarterly Change Control Review

  1. The effectiveness of the change control system is to be determined on quarterly basis in Quality Council Meeting
    • Total number of Change Control till date
    • Total number of closed Change Control till date
    • Change type / department involved
    • Time duration of procedure from initiation to closing
    • Total number of internal or external complaints leading to change control

Attached Documents (Forms / Annexure)

  1. Flow Diagram of Change Control (Annexure A)
  2. Format of Change Control Log Book (Annexure B)
  3. Change Control Form (QA/FRM/0000/00)

Reference & Linked Documents

  1. ICH, Q10 Pharmaceutical Quality System (ICH, June 2023)
  2. European Commission, EudraLex Volume 4, Part I, Chapter 4 Documentation
  3. SOP for Management of Documents

Revision History

Revision No. Date Responsible Person /Designation Description of Change

Distribution List

Recipients Copy Number Issued on (Signature / Date) Withdrawn on (Signature / Date)
Quality Assurance Master
Quality Assurance 01
Quality Control 02
Production 03
Engineering 04
Administration 05
Procurement 06
WHD Raw Material 07
WHD FG Store 08
IT 09
Accounts 10
Export 11
Regulatory Affairs 12
Research & Development 13

Annexure A: Flow Diagram of Change Control

Annexure B: Format of Change Control Log Book

                                                                       Section A To be completed by Change Initiator
Date: ______________________________
Name of Change Initiator: _________________
Designation / Department of Change Initiator: ________
Nature of Change:      Document      System                        Facility                        VendorEquipment / InstrumentOther(s) __________________________
Description of change:____________________Justification for change:_____________________Change Priority:                  High                                       Medium                                  Low

Proposed Implementation Date: ______________________________

Head of Department (Sign. / Date): _____________________________

Section B  To be completed by QA 

Change Control Number: _____________________

Category of Change:              Major                                      Minor 

If change control is on the basis of Complaint No. / CAPA No. / Deviation No. / OOS No. mention No.:________________

Impact Assessment: _______________________

Requested change is: Approved         Hold                            Rejected                  

Change Control Committee: 

 Section C  To be completed by QA 

List of Areas Impacted by the Change 

1) ___________________________

2) _________________________

3) ___________________________

4) _________________________

List of Documents Impacted by the Change 

1) ___________________________

2) _________________________

3) ___________________________

4) _________________________

Sr No. Action (s) taken for implementation including revalidation (if any) Person Responsible Target Date
1      
2      
3      
4      
5      

QA Manager or Designee: ______________________
Implementation Date: ___________________________

Change Implemented Successfully                 Yes                  No
If No, give reason ____________________________ 
 Section D Follow Up  & Final Closure
1.  Implemented change was effective/ problem resolved                               Yes                  No2.  Implemented change was productive                                                         Yes                 No3.  Implemented change resulted in improvement                                           Yes                 No
Provide reasoning if action taken not effective / did not resolve the problem:____________

List of Concerned Departments 

1) ___________________________

2) _________________________

3) ___________________________

4) _________________________

5) ___________________________

6) _________________________ 

Conclusion: ________________

Change Control Closed On: ______________

GM QA or Designee: ____________________

Director Technical / Operations: ______________

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