SOP for Checking Batch Number, Manufacturing Date, and Expiry Date at Receipt – V 2.0

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SOP for Checking Batch Number, Manufacturing Date, and Expiry Date at Receipt – V 2.0

Standard Operating Procedure for Checking Batch Number, Manufacturing Date, and Expiry Date at Receipt

Department Warehouse / Quality Assurance / Quality Control
SOP No. SOP/RM/013/2025
Supersedes SOP/RM/013/2022
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 steps for verifying and documenting the batch number, manufacturing date, and expiry date of raw materials at the time of receipt. Accurate identification and confirmation of these details ensure that only materials meeting the company’s quality standards and shelf-life requirements enter production or storage. By adhering to this SOP, the organization complies with Good Manufacturing Practices (GMP), maintains product integrity, and upholds regulatory obligations. Additionally, it facilitates efficient inventory rotation (First-Expiry-First-Out or FEFO), prevents the risk of expired or unsuitable materials being used, and supports robust traceability in the event of recalls or deviations.

2. Scope

This SOP applies to all raw materials—active pharmaceutical ingredients (APIs), excipients, packaging materials, and any other consumables—delivered to the facility’s receiving dock or warehouse. It specifically targets the verification of:

  • Batch Number: The unique identifier assigned by the manufacturer to a specific production batch.
  • Manufacturing Date: The date on which the batch was produced, relevant for calculating shelf-life or retest intervals.
  • Expiry Date (or Retest Date): The date after which the material may no longer meet its quality specifications.

All Warehouse Personnel, Quality Assurance (QA), and Quality Control (QC) staff involved in receiving, inspecting, and approving materials must follow this SOP. Procurement may also reference these guidelines when communicating with suppliers about required labeling standards or addressing discrepancies in labeling.

3. Responsibilities

  • Warehouse Personnel:
    • Check received containers for clear, legible labels containing batch numbers, manufacturing dates, and expiry (or retest) dates.
    • Document all verified details in the Raw Material Receiving Register and highlight any missing, unclear, or suspect information.
    • Segregate and quarantine materials that have incomplete or non-compliant labeling until QA determines the next steps.
  • Quality Assurance (QA) Team:
    • Define acceptable labeling standards and ensure that suppliers comply with these requirements.
    • Investigate any discrepancies found during the verification process and decide whether to release, re-label, or reject materials that have labeling issues.
    • Oversee all deviations or non-conformances relating to batch numbers, manufacturing dates, and expiry dates, and coordinate corrective/preventive actions (CAPA).
    • Approve final product placement in inventory systems, confirming valid remaining shelf life.
  • Quality Control (QC) Team (If Applicable):
    • Conduct additional testing or sampling if material identification is questionable or if QA suspects tampering or mislabeling.
    • Confirm the validity of labeling data against Certificates of Analysis (CoAs) and testing results for high-risk or critical raw materials.
  • Procurement Department (If Applicable):
    • Ensure that all Purchase Orders (POs) specify proper labeling requirements (batch number, manufacturing and expiry dates) and that suppliers are contractually obliged to meet these standards.
    • Communicate with suppliers to resolve any disputes or consistent labeling inaccuracies.

4. Accountability

The Warehouse Manager is accountable for implementing this SOP on a daily basis, ensuring that each shipment is thoroughly inspected for accurate labeling. The QA Manager maintains ultimate authority over any decisions regarding labeling discrepancies, including releasing, quarantining, or rejecting materials. Any revisions to this SOP must be reviewed and approved by the QA Manager or an equivalent authority to preserve compliance with current GMP and regulatory guidelines.

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5. Procedure

5.1 Pre-Receipt Preparations

Before any raw materials arrive, Warehouse Personnel should be prepared to check labels for required information. Adequate planning ensures a smooth verification process.

  1. Review Purchase Order (PO) and Supplier Documents

    1. Obtain the PO and packing list from the Procurement Department or the electronic system. Confirm that the PO outlines the material name, expected batch number format, and shelf-life requirements (e.g., “Minimum 80% of shelf life remaining upon receipt”).
    2. Check any known special conditions: for instance, if the PO requests a retest date rather than a conventional expiry date, or if the supplier typically delivers multiple batch numbers in a single shipment.
  2. Set Up Receiving Area

    1. Ensure the receiving dock is clean, well-lit, and ready for inspection. Clear any unrelated items that might hinder the labeling verification process.
    2. Have the necessary stationery or electronic devices available to record batch numbers, manufacturing dates, and expiry dates in the Raw Material Receiving Register or Warehouse Management System (WMS).

5.2 Unloading and Initial Checks

Once the shipment arrives, Warehouse Personnel must safely offload the materials and perform a preliminary inspection to identify any obvious label damage or omissions.

  1. Offloading Procedure

    1. Unload pallets or individual containers with the correct handling equipment (forklifts, pallet jacks), observing safety measures to avoid damaging labels.
    2. Inspect the exterior packaging for tears, water damage, or other signs that could compromise label legibility. Note all anomalies in the receiving log.
  2. Label Presence and Legibility

    1. Verify that each container (drum, bag, box, etc.) has a legible label containing at least the material name, batch number, manufacturing date, and expiry (or retest) date. If the label is faded or torn, place the item in quarantine until QA provides guidance.
    2. Check for additional details like storage conditions (e.g., “Store at 2–8°C,” “Keep Dry”), hazard symbols, or barcodes if mandated by internal policy or regulatory requirements.

5.3 Verifying Batch Number, Manufacturing Date, and Expiry Date

This step forms the core of the SOP, ensuring that labeling data meets organizational standards and regulatory requirements, and that the material remains suitable for future use.

  1. Batch Number Validation

    1. Compare the batch number on each container with the batch number stated on the supplier’s documents (packing list, Certificate of Analysis). Ensure the characters, sequence, and format match the supplier’s standard labeling practices.
    2. If the shipment includes multiple batch numbers, separate containers accordingly and label them in the Raw Material Receiving Register (Annexure-1). Avoid mixing or stacking containers of different batches in a way that could lead to confusion.
    3. Flag any unexplained or extra batch numbers not listed on the PO or supplier documents. These items must be quarantined, and QA/Procurement should be contacted to confirm their legitimacy.
  2. Manufacturing Date Check

    1. Identify the manufacturing date on the label, which may be indicated by “Mfg. Date,” “Dom,” or other manufacturer-specific terminology. Ensure it is formatted consistently (e.g., DD/MM/YYYY or MM/YYYY) and can be clearly interpreted.
    2. Cross-verify the manufacturing date with any CoA details, if provided. For example, the CoA might list a production date or release date. Significant mismatches (e.g., a label stating January 2025 while the CoA states March 2025) require further investigation by QA.
    3. If the manufacturing date is missing, unreadable, or appears to have been tampered with, segregate the material for QA review. Materials without a valid manufacturing date can pose risks to product quality and traceability.
  3. Expiry (or Retest) Date Confirmation

    1. Locate the expiry or retest date on the container. Some manufacturers provide only a retest date for chemicals or excipients, especially if they have an extended or indefinite shelf life. In such cases, confirm with QA that this meets internal requirements.
    2. Check that the expiry date is not overly close to the current date, ensuring that the material retains enough remaining shelf life to be feasible for use. The internal policy might require at least 6 months or 12 months remaining, depending on the material type and consumption patterns.
    3. If the expiry date has passed, or the retest date is due immediately, set aside the material in quarantine. Notify QA to determine if an extension or re-testing is possible, or if the batch must be rejected.
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5.4 Recording and Cross-Referencing in Receiving Register

After physically verifying label details, Warehouse Personnel must accurately document all findings in the Raw Material Receiving Register and associated systems.

  1. Data Entry in the Receiving Register

    1. Log the date, supplier name, PO number, material name, batch number, manufacturing date, and expiry date for each container in Annexure-1 or the electronic Warehouse Management System (WMS). Include remarks about any discrepancies or damage observed.
    2. Initial or sign each entry to confirm accountability and traceability. If an electronic system is used, ensure the user ID and timestamp are properly recorded.
  2. GRN Number Association

    1. If a Goods Receipt Note (GRN) process is in place, cross-reference the GRN number with the batch number, manufacturing date, and expiry date in the register. This aligns material identification data with financial and procurement records.
    2. Provide QA with a summary of any questionable batches or labeling anomalies so they can decide on quarantine, release, or further testing.
  3. Labeling and Segregation

    1. Attach any required labels (e.g., “Quarantine,” “Approved,” or “Rejected”) based on QA’s directives. Clearly mark containers in quarantine to prevent unauthorized use or mixing with approved stock.
    2. Store quarantined materials in a designated area until QA reviews and approves their release or rejects them if labeling issues are irreconcilable.

5.5 Handling Label Discrepancies or Missing Information

Ensuring correct batch, manufacturing date, and expiry date is crucial for product integrity. Any deviations or missing data must be managed promptly and systematically.

  1. Label Errors or Non-Compliance

    1. If the label lacks any critical element (batch number, manufacturing date, expiry date) or if the data appears tampered with, put the material under hold in quarantine. Notify QA, who may consult Procurement or the supplier for clarification or updated documentation.
    2. For minor labeling defects (e.g., partially smudged but legible date), QA may permit re-labeling under controlled conditions if the supplier provides a valid CoA or supporting documents confirming the correct data.
  2. Immediate Expiry or Past-Due Materials

    1. If the expiry date indicates the material is no longer within a usable timeframe, inform QA. They may opt to reject the material outright or schedule retest procedures (particularly for chemicals that can be reverified for potency).
    2. Record the outcome in the receiving log, referencing any deviation or non-conformance reports raised. Ensure that all relevant parties (QA, Procurement) know that expired stock arrived and might warrant supplier credit or replacement.
  3. Deviation and CAPA

    1. Major or repeated discrepancies (e.g., multiple deliveries lacking proper labels) require a formal deviation report. QA investigates root causes (supplier error, shipping damage, internal mislabeling) and determines corrective/preventive actions.
    2. Procurement may engage the supplier in a CAPA process if labeling issues persist, potentially updating the Approved Vendor List (AVL) or requiring additional label verification steps before dispatch.
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5.6 Final Release or Rejection

QA holds final authority on whether a material with verified batch information and valid shelf life can join approved inventory. If labeling issues are not resolved, the batch may be rejected to maintain product safety and compliance.

  1. QA Review

    1. QA reviews all documented data—batch number, manufacturing date, expiry date, and any relevant CoA. If the material meets internal standards (sufficient shelf life, no labeling errors), QA approves the batch for release.
    2. In cases of questionable data or incomplete reconciliation, QA may require additional sampling or testing by QC to confirm product identity and stability.
  2. Updating Inventory Systems

    1. Once QA releases the batch, the Warehouse updates the electronic or manual stock records, marking the batch as “Approved.” Indicate the verified expiry date or retest date in the system to facilitate proper inventory rotation (FEFO).
    2. If the batch is rejected, label containers “Rejected” and segregate them in the designated reject area. Document all relevant details and reasons in the deviation record. Procurement coordinates returns, replacements, or disposal with the supplier.
  3. Archiving Records

    1. File all records (receiving logs, deviation reports, CoAs, vendor communications) according to the mandatory retention timeline, ensuring they are easily retrievable for internal audits or external inspections.
    2. Maintain strict data integrity policies if electronic systems are used, including controlled permissions and regular backups, so that labeling verifications remain intact and traceable.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • WMS: Warehouse Management System
  • API: Active Pharmaceutical Ingredient
  • CoA: Certificate of Analysis
  • SDS: Safety Data Sheet
  • CAPA: Corrective and Preventive Action
  • AVL: Approved Vendor List
  • FEFO: First-Expiry-First-Out

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)
  3. Certificates of Analysis (CoAs), Supplier Invoices, Packing Lists
  4. GRN (Goods Receipt Note) Documentation (if applicable)
  5. Deviation or 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, QA, and Warehouse Policies
  • Approved Vendor List (AVL) Documentation

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 Manufacturing Date Expiry Date PO Number Remarks
01/02/2025 ABC Pharma API A A-2025-01 01/01/2025 01/01/2027 PO-55555 No Discrepancy
02/02/2025 XYZ Chemicals Excipient B B-2025-02 12/2024 12/2026 PO-66666 Mixed Batches Found

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 API A A-2025-01 John Doe Assay, Purity Pass
03/02/2025 Excipient B B-2025-02 Jane Smith Identification, pH Pending

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 procedures for verifying batch and date labels
01/02/2025 2.0 Enhanced Label Checks Standardization of Document QA Head All All Included more comprehensive guidelines on expiry date management and retest dates
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