SOP Guide for Pharma

SOP for Sample Collection for Quality Testing in Granules

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SOP for Sample Collection for Quality Testing in Granules

Standard Operating Procedure for Sample Collection for Quality Testing in Granules

1) Purpose

The purpose of this SOP is to outline the standardized procedure for collecting samples of granule formulations for quality testing in the pharmaceutical industry, ensuring that samples are representative and compliant with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the collection of granule samples for quality testing within the pharmaceutical production and quality control (QC) departments.

3) Responsibilities

Production Department: Responsible for providing the necessary samples as per the sampling plan.
Quality Control (QC) Department: Responsible for collecting, labeling, and transporting the samples to the testing laboratory.
Quality Assurance (QA) Department: Responsible for reviewing and approving the sampling process and ensuring compliance with the SOP.

See also  SOP for Conducting Process Validation for Granules

4) Procedure

  1. Preparation:
    1. Ensure that all necessary equipment and materials are available, including sample containers, labels, and personal protective equipment (PPE).
    2. Review the sampling plan and identify the locations and quantities of granules to be sampled.
  2. Sampling Procedure:
    1. Wear appropriate PPE before entering the sampling area.
    2. Clean and sanitize the sampling tools and containers to prevent contamination.
    3. Collect samples from designated locations as specified in the sampling plan, ensuring that the samples are representative of the entire batch.
    4. Use a clean, dry sampling tool
for each sample to avoid cross-contamination.
  • Place the collected sample in a labeled container, ensuring that the label includes the batch number, date, time, and sample location.
  • Sample Handling and Transport:
    1. Seal the sample container securely to prevent leakage or contamination during transport.
    2. Transport the sample to the QC laboratory promptly, maintaining any necessary environmental conditions (e.g., temperature, humidity) as specified.
    3. Document the sample collection and transport details in the sampling log.
  • Documentation:
    1. Record all relevant information about the sample collection process, including the sampling location, date, time, batch number, and any observations.
    2. Ensure that the sampling log is signed by the person responsible for collecting the samples.
  • Quality Testing:
    1. Submit the collected samples to the QC laboratory for analysis as per the specified testing protocols.
    2. Retain a portion of the sample for reference or re-testing if required.
  • Review and Approval:
    1. The QA department reviews the sampling documentation and approves the samples for quality testing.
    2. Ensure compliance with GMP guidelines and regulatory requirements throughout the sampling process.

    • 5) Abbreviations, if any

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

    6) Documents, if any

    Sampling Plan, Sampling Log, QC Testing Protocols

    7) Reference, if any

    GMP guidelines for sample collection in pharmaceutical manufacturing.

    8) SOP Version

    Version 1.0

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