SOP for Sampling at Receiving Stage for Preliminary Inspection – V 2.0

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SOP for Sampling at Receiving Stage for Preliminary Inspection – V 2.0

Standard Operating Procedure for Sampling at Receiving Stage for Preliminary Inspection

Department Warehouse / Quality Control / Quality Assurance
SOP No. SOP/RM/015/2025
Supersedes SOP/RM/015/2022
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) describes the preliminary sampling process for raw materials at the time of receipt. Preliminary sampling is intended to perform basic identification tests, check for physical integrity, and quickly screen for gross contamination or mismatch. By adhering to this SOP, the organization ensures that only compliant materials proceed to full quality testing or storage, minimizing the risk of using substandard or incorrect raw materials in production. This procedure also streamlines quarantine decisions, accelerates the resolution of obvious discrepancies, and maintains regulatory compliance.

2. Scope

This SOP applies to all incoming raw materials—active pharmaceutical ingredients (APIs), excipients, intermediates, and other materials—arriving at the facility’s receiving area. It covers:

  • Pre-sampling checks and area preparation.
  • Procedures for collecting representative samples immediately upon receipt.
  • Documentation of sampling activities and preliminary test results.
  • Coordination between Warehouse, Quality Control (QC), and Quality Assurance (QA) personnel for initial quarantine or further testing decisions.

The sampling described in this SOP is for preliminary inspection purposes only and does not replace the full QC release testing required to approve a raw material for production. All Warehouse and QC personnel involved in the receiving process must follow this procedure, in consultation with QA as needed.

3. Responsibilities

  • Warehouse Personnel:

    • Prepare the designated sampling area and ensure that the raw materials slated for preliminary sampling are correctly identified and labeled.
    • Assist QC personnel by locating and moving containers to the sampling station, following safety protocols for handling, especially if hazardous or temperature-sensitive materials are involved.
    • Record any obvious issues—such as damaged containers or incorrect labeling—in the Raw Material Receiving Register (Annexure-1) and quarantine the materials if directed by QA.
  • Quality Control (QC) Team:

    • Conduct the actual sampling process, following GMP and this SOP, to obtain representative samples for preliminary visual, physical, or basic chemical checks.
    • Document sampling details (e.g., date, batch number, sampling method) in the Sampling Log (Annexure-2) and attach initial results (e.g., ID test) to relevant records.
    • Advise QA if preliminary tests indicate any gross contamination, mismatch, or potential product safety risk.
  • Quality Assurance (QA) Team:

    • Review discrepancies identified during preliminary sampling and decide if immediate quarantine, rejection, or further testing is warranted.
    • Oversee compliance with GMP, internal procedures, and regulatory mandates for sampling and product release.
    • Review and approve any deviations or non-conformances arising from preliminary sampling activities.
  • Procurement (If Applicable):

    • Coordinate with suppliers if preliminary sampling reveals significant issues (e.g., incorrect product, severe contamination) requiring immediate feedback or return-to-vendor steps.

4. Accountability

The Warehouse Manager ensures that sampling areas and procedures align with this SOP. The QC Manager (or delegated personnel) is responsible for training QC staff on correct sampling techniques and ensuring consistency in preliminary testing. Any updates or changes to this SOP must be reviewed and approved by the QA Manager to maintain GMP and regulatory compliance. Procurement may be consulted if supplier-related issues arise, and QA holds final authority over any quarantine or rejection decisions based on preliminary sampling results.

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5. Procedure

5.1 Pre-Sampling Preparations

Adequate planning ensures a smooth and accurate preliminary sampling process, preventing cross-contamination and incorrect labeling.

  1. Sampling Area Setup

    1. Designate a specific sampling station or room near the receiving area, equipped with basic sampling tools (e.g., scoop, spatula, thief sampler), containers, and appropriate PPE (gloves, goggles, lab coats).
    2. Ensure the sampling area is clean, well-lit, and free of other materials. Wipe down surfaces with a suitable cleaning agent and lay out absorbent pads if necessary.
    3. For hazardous or temperature-sensitive materials, confirm that the sampling environment meets safety or temperature control requirements (e.g., fume hood, cold room).
  2. Documentation Readiness

    1. Collect relevant paperwork for each lot to be sampled—Purchase Order (PO), packing list, Certificate of Analysis (CoA) if provided, and any special instructions from QA or Procurement.
    2. Have the Sampling Log (Annexure-2) or electronic equivalent ready to record sampling data. Assign a preliminary sample ID or code, if applicable.
  3. Personnel and Training

    1. Only QC staff trained in GMP sampling practices should perform the sampling. They must understand the correct technique to obtain a representative sample without contaminating the material or compromising its integrity.
    2. Warehouse Personnel assist by moving containers into or out of the sampling station. Both QC and Warehouse staff must adhere to the facility’s gowning and PPE requirements.

5.2 Selecting Containers for Preliminary Sampling

Not all shipments require immediate preliminary sampling. However, certain risk-based factors may prompt QA or QC to request sampling at receipt.

  1. Risk-Based Criteria

    1. High-value or high-risk materials (e.g., potent APIs, materials with a history of quality issues) often warrant preliminary sampling to confirm identity or check for gross contamination.
    2. New suppliers or materials flagged with supplier performance issues may also trigger immediate sampling requests.
    3. Temperature-sensitive shipments, materials in compromised packaging, or large discrepancies between ordered and received quantities are additional triggers for preliminary sampling.
  2. Sampling Plan Definition

    1. QA or QC typically defines the sampling plan, indicating how many containers or what proportion of the lot to sample. For example, 10% of the containers might be sampled or at least one container per lot, whichever is greater.
    2. Plan the sampling sequence so it does not interfere with other receiving operations. Sample selected containers first to expedite the quarantine or acceptance process.

5.3 Sampling Procedure

The actual collection of the sample must follow GMP principles, ensuring that the material remains uncontaminated and that the sample is truly representative.

  1. Container Verification

    1. Identify the container to be sampled—verify the label (material name, batch/lot number) matches the PO or receiving documents. If any mismatch is noted, alert QA before sampling.
    2. Check the container for visible damage, moisture, or tampering. If compromised, note this in the Receiving Register and consult QA on whether to proceed with sampling or quarantine.
  2. Tool and Equipment Preparation

    1. Disinfect or clean sampling tools (scoop, thief sampler) with a suitable agent (e.g., 70% IPA) or follow the facility’s standard cleaning procedure to avoid cross-contamination.
    2. Use dedicated or single-use tools for allergenic or hazardous materials as required by internal safety policies or SDS guidelines.
  3. Sample Collection

    1. Open the container carefully, avoiding contamination. For materials with multiple layers (e.g., drums with inner liners), ensure each layer is opened in a controlled manner.
    2. Insert the sampling tool into different parts of the container (top, middle, bottom) to obtain a representative sample. Transfer the sample into a clean, labeled container (e.g., glass or plastic jar, depending on material compatibility).
    3. Label the sample container with the preliminary sample ID, material name, batch/lot number, and date of sampling. Seal it to prevent contamination or spillage.
See also  SOP for Inspection and Receiving of API, Excipients, and Additives - V 2.0

5.4 Preliminary Inspection and Tests

Preliminary tests generally focus on visual or basic analytical checks to confirm material identity and spot gross issues like adulteration or severe contamination.

  1. Visual Examination

    1. Observe color, texture, and physical form (e.g., powder, granular, liquid). Compare the appearance to historical or reference samples if available.
    2. Check for foreign particles, lumps, or discoloration. Record observations in the Sampling Log (Annexure-2) and attach photos if needed.
  2. Basic Analytical or ID Tests

    1. QC may perform simple chemical spot tests, pH measurements, or quick identification (ID) checks (e.g., FTIR scan, if equipment is available) to verify that the substance aligns with the expected profile.
    2. If the result suggests the material is not what the label indicates, place the entire lot under quarantine, notify QA, and plan a full investigation or advanced testing.
  3. Documentation of Results

    1. Log any preliminary test results in the Sampling Log (Annexure-2) and reference the container/batch from which the sample was drawn. Note the date, time, initials of the QC personnel, and outcome of the test.
    2. Forward the preliminary findings to QA. If the tests confirm expected identity and no gross issues, QA may allow the lot to remain in standard quarantine until full QC release testing.

5.5 Post-Sampling Actions

Depending on the preliminary inspection outcomes, QA decides the next steps: further quarantine, immediate rejection, or continued processing toward full release testing.

  1. Quarantine or Preliminary Release

    1. If no major discrepancies are found, the sampled containers (and the rest of the lot) are placed in the standard quarantine area awaiting full QC testing. Label them as “Quarantine” with references to the sample ID and receiving date.
    2. In cases where the preliminary tests raise concerns (e.g., color mismatch, strong odor, presence of foreign matter), QA may instruct Warehouse Personnel to segregate the entire lot for further investigations or immediate rejection.
  2. Communication with Procurement or Supplier

    1. If the material appears to be incorrect or significantly contaminated, QA or Procurement may contact the supplier for clarification or to initiate return/credit procedures. Provide any relevant data from the preliminary inspection.
    2. Document the communication details, including email threads or call logs, in the batch record for traceability.
  3. Deviation Handling

    1. If a major issue is identified—such as mislabeled product—raise a deviation or non-conformance report per the organization’s quality system. Attach preliminary test results and sampling notes to support the investigation.
    2. QA leads a root-cause analysis and determines corrective/preventive actions (CAPA) if the deviation is traced to supplier errors, internal handling, or any systemic gap.
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5.6 Documentation and Record-Keeping

Thorough documentation ensures traceability, supports regulatory compliance, and provides a reference in case of future investigations or recalls.

  1. Raw Material Receiving Register

    1. Update the Raw Material Receiving Register (Annexure-1) with details of the containers sampled, preliminary inspection date, and any short remarks (e.g., “ID test done – OK”).
    2. Sign or initial each entry to confirm accountability. If an electronic system is used, ensure user IDs and timestamps are captured for data integrity.
  2. Sampling Log

    1. Document all samples in the Sampling Log (Annexure-2), including the reason for sampling (e.g., “Preliminary ID check”), quantity or volume taken, batch/lot number, and the partial or entire container from which the sample was taken.
    2. Record preliminary test results under the appropriate column. If additional lab sheets or printouts are generated (like FTIR spectra), attach or reference them to maintain a complete record.
  3. Archiving and Retention

    1. Maintain all preliminary sampling records alongside the full QC release documentation to provide a continuous audit trail from receipt to final product release. Store them per local regulations or internal policy (commonly 5–7 years).
    2. Restrict edits in the electronic system to authorized personnel. Keep daily backups if feasible, ensuring data reliability for audits or future reference.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PO: Purchase Order
  • PPE: Personal Protective Equipment
  • SDS: Safety Data Sheet
  • CoA: Certificate of Analysis
  • CAPA: Corrective and Preventive Action
  • FTIR: Fourier Transform Infrared Spectroscopy

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)
  3. Purchase Orders (POs) and Packing Lists
  4. Certificates of Analysis (CoAs)
  5. Deviation / Non-Conformance Reports (if applicable)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • Company-Specific Procurement and Warehouse Policies
  • Quality Control Testing 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: Raw Material Receiving Register

Date Supplier Name Material Name Batch Number PO Number Remarks
01/02/2025 ABC Chemicals API-X AX-2025-01 PO-12345 Selected for Preliminary Sampling
02/02/2025 XYZ Pharma Supplies Excipient Y EY-2025-05 PO-67890 High-risk Material, Immediate Check

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel Preliminary Test Performed Result Remarks
01/02/2025 API-X AX-2025-01 John Doe ID Test (FTIR) Pass No Contaminants
02/02/2025 Excipient Y EY-2025-05 Jane Smith Visual, pH Pending Possible Color Variation

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 1.0 Initial Version New SOP Creation QA Head All All Established procedure for preliminary sampling at receiving
01/02/2025 2.0 Expanded Test Guidance Standardization of Document QA Head All All Included additional ID test options and clarified quarantine steps
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