SOP Guide for Pharma

SOP for Sampling Frequency and Criteria for Raw Materials in Quarantine – V 2.0

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SOP for Sampling Frequency and Criteria for Raw Materials in Quarantine – V 2.0

Standard Operating Procedure for Sampling Frequency and Criteria for Raw Materials in Quarantine

Department Quality Control / Quality Assurance / Warehouse
SOP No. SOP/RM/078/2025
Supersedes SOP/RM/078/2022
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) defines the frequency and criteria for sampling raw materials stored in the quarantine area. It ensures that materials are sampled correctly to maintain quality, safety, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials received and stored in the quarantine area before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

  • Quality Control (QC) Personnel: Perform sampling as per defined frequencies and criteria, and maintain sampling records.
  • Warehouse Personnel: Facilitate access to quarantined materials and ensure proper labeling and segregation.
  • Quality Assurance (QA): Review sampling procedures, verify compliance, and approve sampling plans.

4. Accountability

The QC Manager is responsible for ensuring that sampling is conducted per this SOP. The QA Manager ensures compliance with regulatory standards, and the Warehouse Manager ensures

proper storage and segregation of sampled materials.
See also  SOP for Handling and Unpacking Large Bulk Material Containers - V 2.0

5. Procedure

5.1 General Sampling Guidelines

  1. Sampling Environment:
    • Conduct sampling in designated sampling areas under controlled environmental conditions to prevent contamination.
    • Ensure all sampling equipment is clean, calibrated, and sanitized before use.
  2. Personnel Requirements:
    • Only trained and authorized personnel are permitted to perform sampling.
    • Personnel must wear appropriate personal protective equipment (PPE) as per SOP for handling quarantined materials.

5.2 Sampling Frequency

  1. New Materials:
    • For new suppliers or materials, sample every batch received until a consistent quality record is established (minimum of 5 consecutive conforming batches).
  2. Routine Sampling:
    • For approved suppliers, sample each batch received.
    • For materials with extended shelf life and stable history, sampling frequency may be reduced based on risk assessment and QA approval.
  3. Re-Test or Re-Evaluation:
    • Materials stored in quarantine for more than 6 months must undergo re-sampling and testing.
    • Materials approaching expiry should be sampled for re-evaluation based on the material’s stability data.

5.3 Sampling Criteria

  1. Sampling Quantity:
    • The quantity to be sampled is based on the type of material, container size, and specific test requirements.
    • Refer to the Sampling Quantity Chart (Annexure-1) for standard sampling amounts.
  2. Sampling Methodology:
    • Follow random sampling techniques to ensure representative samples.
    • For solids, use sampling thieves or scoops. For liquids, use pipettes or sampling bottles.
    • For hazardous materials, follow additional safety protocols and use specialized equipment.
  3. Container Selection:
    • For batches with fewer than 5 containers, sample from all containers.
    • For batches with 5-10 containers, sample from at least 50% of the containers.
    • For batches with more than 10 containers, sample from a minimum of 10 containers or as specified by QA.
See also  SOP for Inspection of Double-Checked and Double-Bagged Raw Materials - V 2.0

5.4 Documentation of Sampling

  1. Sampling Records:
    • Document all sampling activities in the Sampling Log (Annexure-2), including:
      • Date and time of sampling
      • Material name and batch number
      • Quantity sampled
      • Sampling method and equipment used
      • Personnel involved in sampling
  2. Sample Labeling:
    • Label samples with:
      • Material name
      • Batch number
      • Sampled by (name and signature)
      • Date of sampling
    • Ensure samples are transported to the QC lab in sealed, contamination-free containers.

5.5 Handling Deviations in Sampling

  1. Deviation Reporting:
    • Report any deviations from the sampling procedure to the QA Manager immediately.
    • Document deviations in the Sampling Deviation Report (Annexure-3).
  2. Corrective Actions:
    • Investigate the root cause of the deviation and implement corrective actions.
    • Document corrective actions in the Corrective Action Log (Annexure-4).

6. Abbreviations

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

7. Documents

  1. Sampling Quantity Chart (Annexure-1)
  2. Sampling Log (Annexure-2)
  3. Sampling Deviation Report (Annexure-3)
  4. Corrective Action Log (Annexure-4)

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)
See also  SOP for Receiving Raw Materials with Special Handling Instructions - V 2.0

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 Quantity Chart

Material Type Container Size Sampling Quantity Sampling Equipment
API 25 kg Drum 200 g Sampling Thief
Solvent 50 L Drum 500 ml Sampling Bottle

Annexure-2: Sampling Log

Date Material Name Batch Number Quantity Sampled Sampled By Verified By (QA)
01/02/2025 API-X X-2025-001 200 g Ravi Kumar Anjali Mehta
01/02/2025 Solvent-Y Y-2025-002 500 ml Sunita Sharma Ajay Singh

Annexure-3: Sampling Deviation Report

Date Material Name Batch Number Deviation Description Reported By Corrective Action Taken
02/02/2025 API-X X-2025-001 Incorrect Quantity Sampled Ravi Kumar Resampled Correct Quantity

Annexure-4: Corrective Action Log

Date Deviation Description Corrective Action Implemented By Verified By (QA)
03/02/2025 Incorrect Sampling Method Re-trained Sampling Personnel Ajay Singh Anjali Mehta

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 Frequency and Criteria Procedures Regulatory Compliance QA Head
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