review and implementation of updated quarantine procedures. The Regulatory Affairs Manager is responsible for identifying regulatory changes and ensuring their communication to relevant stakeholders.

5. Procedure

5.1 Monitoring Regulatory Changes

1. Identifying Regulatory Updates:
   • Regulatory Affairs must regularly monitor updates from regulatory bodies such as the FDA, EMA, WHO, and ICH.
   • Subscribe to regulatory newsletters, attend industry conferences, and review official guidance documents.
   • Document identified changes in the Regulatory Monitoring Log (Annexure-1).
2. Initial Assessment of Regulatory Changes:
   • Regulatory Affairs will assess the relevance of new regulations to quarantine procedures.
   • Prepare a Regulatory Impact Assessment Report (Annexure-2) summarizing the implications for current SOPs.

5.2 Reviewing Existing Quarantine Procedures

1. Comparative Review:
   • QA will review existing SOPs in comparison with new regulatory requirements.
   • Identify gaps or discrepancies and record them in the SOP Review Log (Annexure-3).
2. Consultation with Relevant Departments:
   • QA will consult with Warehouse, QC, and EHS teams to gather feedback on proposed changes.
   • Document feedback and suggestions in the Feedback and Consultation Log (Annexure-4).

5.3 Updating Quarantine Procedures

1. Drafting Updated SOPs:
   • QA will draft updated SOPs incorporating the new regulatory requirements.
   • Ensure that the updated SOP includes revised procedures, responsibilities, and documentation requirements.
   • Record updates in the SOP Revision Log (Annexure-5).
2. Approval of Updated SOPs:
   • Submit the updated SOPs to the Regulatory Affairs team for review and approval.
   • Obtain final approval from the QA Manager and document in the SOP Approval Log (Annexure-6).

5.4 Implementation of Updated Procedures

1. Communication of Changes:
   • QA will communicate the updated SOPs to all relevant departments.
   • Issue formal communication via email, memos, and staff meetings.
   • Document communication activities in the SOP Implementation Log (Annexure-7).
2. Training on Updated Procedures:
   • Conduct training sessions for all personnel involved in quarantine operations.
   • Record attendance and training details in the Training Log (Annexure-8).

5.5 Monitoring Compliance with Updated Procedures

1. Internal Audits:
   • QA will conduct periodic audits to ensure compliance with updated quarantine procedures.
   • Document audit findings in the Compliance Audit Log (Annexure-9).
2. Corrective Actions:
   • Identify any non-compliance issues and implement corrective actions as needed.
   • Record corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• RA: Regulatory Affairs

7. Documents

1. Regulatory Monitoring Log (Annexure-1)
2. Regulatory Impact Assessment Report (Annexure-2)
3. SOP Review Log (Annexure-3)
4. Feedback and Consultation Log (Annexure-4)
5. SOP Revision Log (Annexure-5)
6. SOP Approval Log (Annexure-6)
7. SOP Implementation Log (Annexure-7)
8. Training Log (Annexure-8)
9. Compliance Audit Log (Annexure-9)
10. Corrective Action Log (Annexure-10)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EMA Guidelines for Quarantine and Release Procedures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Regulatory Monitoring Log

Date	Regulatory Body	Update Description	Identified By
01/02/2025	FDA	Updated GMP guidelines for raw material quarantine	Anjali Mehta

Annexure-2: Regulatory Impact Assessment Report

Date	Update Description	Impact on SOP	Prepared By
02/02/2025	New labeling requirements for quarantined materials	Update labeling procedure in SOP	Anjali Mehta

Annexure-3: SOP Review Log

Date	SOP Title	Reviewed By	Findings
03/02/2025	Quarantine Management SOP	Ravi Kumar	Outdated labeling process identified

Annexure-4: Feedback and Consultation Log

Date	Department	Feedback Provided	Recorded By
04/02/2025	Warehouse	Request for clearer labeling instructions	Sunita Sharma

Annexure-5: SOP Revision Log

Date	SOP Title	Revision Description	Revised By
05/02/2025	Quarantine Management SOP	Updated labeling requirements per FDA guidance	Anjali Mehta

Annexure-6: SOP Approval Log

Date	SOP Title	Approved By	Signature
06/02/2025	Quarantine Management SOP	QA Manager

Annexure-7: SOP Implementation Log

Date	SOP Title	Departments Informed	Communication Method
07/02/2025	Quarantine Management SOP	Warehouse, QA, QC	Email, Meeting

Annexure-8: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
08/02/2025	Updated Quarantine Procedures	QA Manager	Ravi Kumar

Annexure-9: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
09/02/2025	Compliance with Updated SOPs	All departments compliant	N/A	Anjali Mehta

Annexure-10: Corrective Action Log

Date	Issue Identified	Corrective Action	Implemented By
10/02/2025	Incorrect labeling format	Updated labeling instructions provided to warehouse staff	Sunita Sharma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Quarantine Procedures Based on New FDA Guidelines	Regulatory Compliance	QA Head