Standard Operating Procedure for Designation of Sampling Zones in Quarantine Area

Department	Warehouse / Quality Assurance / Quality Control
SOP No.	SOP/RM/067/2025
Supersedes	SOP/RM/067/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedures for designating and managing sampling zones within the quarantine area to ensure sample integrity, prevent contamination, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials that are sampled within the quarantine area before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

• Warehouse Personnel: Maintain cleanliness and organization in designated sampling zones.
• Quality Control (QC) Personnel: Perform sampling according to specified procedures and ensure proper documentation.
• Quality Assurance (QA): Oversee sampling zone compliance with GMP and approve any procedural deviations.

4. Accountability

The Warehouse Manager is responsible for setting up and maintaining sampling zones in the quarantine area. The QC Manager ensures that sampling procedures meet regulatory standards, while the QA Manager verifies compliance with GMP and internal protocols.

5. Procedure

5.1 Designation of Sampling Zones

1. Identification of Sampling Zones:
   • Designate specific areas within the quarantine zone exclusively for raw material sampling.
   • Each sampling zone must be clearly labeled and color-coded for easy identification (Annexure-1).
2. Segregation by Material Type:
   • Separate sampling zones should be designated for:
     • APIs
     • Excipients
     • Hazardous Materials
     • Temperature-Sensitive Materials
   • Ensure that incompatible materials are sampled in separate areas to prevent cross-contamination.

5.2 Setup and Maintenance of Sampling Zones

1. Environmental Controls:
   • Maintain controlled temperature and humidity in the sampling zones as per material specifications.
   • Install High-Efficiency Particulate Air (HEPA) filters where required for sterile or sensitive materials.
2. Cleaning and Sanitization:
   • Clean and sanitize sampling areas before and after each use.
   • Record cleaning activities in the Sampling Zone Cleaning Log (Annexure-2).

5.3 Sampling Procedure in Designated Zones

1. Preparation for Sampling:
   • Ensure that all required sampling tools and containers are sterilized and ready for use.
   • QC personnel must wear appropriate personal protective equipment (PPE), including gloves, lab coats, and masks.
2. Conducting Sampling:
   • Sample raw materials according to approved sampling plans and procedures.
   • Label all samples immediately with relevant information: material name, batch number, date, and sampler’s initials.
   • Document sampling details in the Sampling Log (Annexure-3).

5.4 Handling and Storage of Samples

1. Sample Transportation:
   • Transport samples to the QC laboratory in designated, contamination-proof containers.
   • Record sample transportation in the Sample Transportation Log (Annexure-4).
2. Sample Retention:
   • Retain a portion of the sample in a secured, labeled container for reference.
   • Store retained samples in accordance with material-specific storage conditions.

5.5 Deviations and Corrective Actions

1. Handling Deviations:
   • Any deviations from sampling procedures or environmental controls must be documented in the Sampling Deviation Report (Annexure-5).
   • QA will review deviations and determine appropriate corrective actions.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

7. Documents

1. Sampling Zone Map (Annexure-1)
2. Sampling Zone Cleaning Log (Annexure-2)
3. Sampling Log (Annexure-3)
4. Sample Transportation Log (Annexure-4)
5. Sampling Deviation Report (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sampling Zone Map

A detailed map outlining the designated sampling zones in the quarantine area. Zones should be color-coded as follows:

• Zone A (APIs): Blue
• Zone B (Excipients): Green
• Zone C (Hazardous Materials): Red
• Zone D (Temperature-Sensitive Materials): Yellow

Annexure-2: Sampling Zone Cleaning Log

Date	Sampling Zone	Cleaned By	Verified By (QA)	Remarks
01/02/2025	Zone A (APIs)	Ravi Kumar	Anjali Mehta	Cleaned and Sanitized
01/02/2025	Zone C (Hazardous Materials)	Ajay Singh	Sunita Sharma	Sanitization Completed

Annexure-3: Sampling Log

Date	Material Name	Batch Number	Sampling Zone	Sampled By	Remarks
01/02/2025	API-X	X-2025-001	Zone A	Priya Desai	Sample Collected
01/02/2025	Excipient-Y	Y-2025-002	Zone B	Anil Mehta	No Contamination Observed

Annexure-4: Sample Transportation Log

Date	Material Name	Batch Number	Transported To	Transported By	Remarks
01/02/2025	API-X	X-2025-001	QC Laboratory	Ramesh Patel	Transported in Sealed Container

Annexure-5: Sampling Deviation Report

Date	Material Name	Batch Number	Deviation Description	Reported By	Corrective Action Taken
02/02/2025	Excipient-Y	Y-2025-002	Incorrect Labeling	Sunita Sharma	Relabeled and Verified

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 Sampling Zones and Documentation Procedures	Regulatory Compliance	QA Head