facilities. It does not apply to permanent changes, which must follow the Change Control SOP.

3. Responsibilities

• Initiator (Process Owner): Submits the Temporary Change Request (TCR) with justification.
• QA Department: Evaluates, reviews, approves, and tracks temporary changes.
• Functional Departments: Implement approved temporary changes and ensure compliance during the defined period.

4. Accountability

The Head of Quality Assurance is accountable for ensuring all temporary changes are justified, risk-assessed, and managed within regulatory and GMP-compliant frameworks.

5. Procedure

5.1 Initiation of Temporary Change

1. The department requiring a temporary change shall complete the Temporary Change Request Form (Annexure-1) detailing:
   • Reason for change
   • Scope and impact
   • Duration of proposed change
   • Risk mitigation strategy
2. The initiator must submit the form to QA for evaluation.

5.2 Risk Assessment and Impact Evaluation

1. QA, in consultation with cross-functional teams, shall assess:
   • Impact on product quality, safety, and efficacy
   • Compliance with regulatory filings
   • Documentation and data integrity
   • Training and monitoring requirements
2. A Risk Assessment Checklist (Annexure-2) must be completed.
3. If the change impacts a registered dossier, Regulatory Affairs must be consulted.

5.3 Approval of Temporary Change

1. Upon satisfactory evaluation, QA shall approve or reject the TCR.
2. Approval shall include:
   • Start and end dates
   • Conditions for execution
   • Monitoring parameters
3. Final approval shall be documented in the TCR Approval Sheet (Annexure-3).

5.4 Communication and Training

1. All concerned departments shall be informed of the temporary change.
2. If required, a training session must be conducted and recorded using the Training Record Log (Annexure-4).

5.5 Implementation and Monitoring

1. Departments must implement the temporary change only during the approved timeframe.
2. QA shall conduct periodic checks to ensure compliance using the Temporary Change Monitoring Log (Annexure-5).
3. Any deviation during implementation must be handled per the Deviation Handling SOP.

5.6 Reversion to Original Procedure

1. Upon expiration of the temporary change period:
   • Operations must revert to the original SOP/process.
   • QA shall verify reversion using the Closure Checklist (Annexure-6).
2. A Temporary Change Closure Report (Annexure-7) must be completed and signed.

5.7 Extension or Conversion to Permanent Change

1. In case the temporary change is beneficial and intended to continue, the department shall initiate a formal Change Control Request (CCR) and close the TCR accordingly.
2. QA shall not permit extension beyond 90 calendar days without Head QA authorization and documented justification.

6. Abbreviations

• TCR: Temporary Change Request
• QA: Quality Assurance
• CCR: Change Control Request
• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practices

7. Documents

1. Temporary Change Request Form (Annexure-1)
2. Risk Assessment Checklist (Annexure-2)
3. TCR Approval Sheet (Annexure-3)
4. Training Record Log (Annexure-4)
5. Temporary Change Monitoring Log (Annexure-5)
6. Closure Checklist (Annexure-6)
7. Temporary Change Closure Report (Annexure-7)

8. References

• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals
• EU GMP Chapter 1 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Temporary Change Request Form

Change Title	Initiator	Department	Reason	Proposed Duration
Alternate Equipment for Granulation	Rajesh Kumar	Production	Breakdown of primary equipment	7 days

Annexure-2: Risk Assessment Checklist

Parameter	Risk Level (Low/Med/High)	Mitigation
Impact on Product Quality	Medium	Increased IPC frequency
Regulatory Impact	Low	Not registered yet

Annexure-3: TCR Approval Sheet

TCR No.	Approved By	Effective Date	Expiry Date
TCR/2025/014	QA Head	15/04/2025	22/04/2025

Annexure-4: Training Record Log

Date	Name	Department	Trainer	Signature
14/04/2025	Sunita Reddy	QA	QA Officer

Annexure-5: Temporary Change Monitoring Log

Date	Parameter Checked	Observation	Inspector
16/04/2025	IPC Sampling	Compliant	QA Officer

Annexure-6: Closure Checklist

Checklist Item	Status	Remarks
Original SOP Re-implemented	Yes	Completed
Training on Reversion	Yes	Documented

Annexure-7: Temporary Change Closure Report

TCR No.	Date Closed	Closed By	Remarks
TCR/2025/014	23/04/2025	QA Manager	Successfully reverted

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Clarified timelines and added risk assessment section	Regulatory Compliance	QA Head