SOP Guide for Pharma

SOP for Weighing and Cross-Verification of Received Materials – V 2.0

Auditor

SOP for Weighing and Cross-Verification of Received Materials – V 2.0

Standard Operating Procedure for Weighing and Cross-Verification of Received Materials

Department Quality Assurance / Warehouse
SOP No. SOP/RM/008/2025
Supersedes SOP/RM/008/2022
Page No. Page 1 of 14
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) aims to define a consistent, GMP-compliant process for weighing and cross-verifying raw materials upon receipt. Accurate weight measurement and verification are critical to identifying discrepancies in quantity, detecting potential shortages or overages, and ensuring that suppliers adhere to the agreed-upon specifications. By implementing a systematic weighing procedure and cross-verification protocol, the organization maintains proper inventory control, prevents financial losses, and upholds product quality and safety standards.

2. Scope

This SOP applies to all raw materials—active pharmaceutical ingredients (APIs), excipients, intermediates, and other materials—delivered to the facility’s receiving area. It outlines responsibilities for Warehouse Personnel, Quality Assurance (QA), and any other relevant departments involved in the material handling and documentation process. The procedure covers initial weight checks, cross-verification of quantities, documentation of discrepancies, and subsequent actions if shortages or overages are identified.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for ensuring that all incoming materials are properly weighed and documented according to this SOP. The QA Manager (or a delegated representative) has final accountability for reviewing weight discrepancies, deciding on corrective actions, and updating this SOP as needed. Procurement is responsible for coordinating with suppliers regarding weight or quantity disputes. Any modifications to these procedures or consistent variances must be escalated to QA management for review and approval.

5. Procedure

5.1 Preparation for Weighing

  1. Check Weighing Equipment
    1. Before starting, verify that the weighing scales or balances are calibrated and within their valid calibration period. If the calibration date has expired, do not proceed; notify QA for guidance.
    2. Confirm the scale’s zero reading and ensure it is on a flat, stable surface to avoid measurement errors.
    3. If using electronic scales, check that the battery or power source is stable and that no error messages are displayed on the digital readout.
  2. Work Area Preparation
    1. Clear the area around the scale of unnecessary items or debris that could affect weight readings. Maintain a clean, well-lit space to reduce the risk of accidents or contamination.
    2. Review the Purchase Order (PO) and supplier documentation (e.g., packing list, delivery note) to confirm the expected net weight and the total number of containers or bags.
  3. Personnel and PPE
    1. Warehouse Personnel must wear appropriate personal protective equipment (PPE) as specified by the material’s Safety Data Sheet (SDS). This may include gloves, masks, or other protective garments depending on the hazard class.
    2. Ensure that only authorized personnel trained in the weighing process have access to the weighing area to prevent tampering or data integrity issues.
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5.2 Weighing the Materials

  1. Individual Container Weighing
    1. Place the container (drum, bag, or box) gently on the scale. Record the gross weight as displayed on the readout. If the container comes with pallet or other external packaging, remove any extraneous material first or tare the scale accordingly.
    2. If multiple containers are shipped in a single pallet, weigh each container separately unless a verified tare weight is available for the pallet itself.
    3. For materials in sealed bags within drums, weigh the entire drum with the bag inside. If necessary, the drum weight can be subtracted later (if the drum’s tare weight is accurately known).
  2. Bulk Pallet Weighing (If Applicable)
    1. For large shipments delivered on pallets, weigh the entire pallet at once. Ensure the pallet’s tare weight is known and subtract it from the total to get the net weight.
    2. Compare the total net weight of the pallet (sum of all containers minus pallet weight) with the total net weight reported by the supplier.
  3. Zero or Tare Adjustments
    1. Use the tare function (if available) to account for packaging materials, pallets, or other containers that are not part of the material’s net weight. Document the tare values clearly in the receiving records.
    2. Periodically re-check the scale zero to ensure accuracy, especially if you weigh multiple containers in succession.

5.3 Cross-Verification of Weights

  1. Supplier Documentation Check
    1. Compare the measured weights with the net weights indicated on the supplier’s packing list, bill of lading, or other shipping documents. Note any variance in the Raw Material Receiving Register (Annexure-1).
    2. For large consignments, calculate the cumulative difference between the supplier’s declared total weight and the actual measured total weight. If the difference exceeds the established tolerance (e.g., ±0.5%), inform QA immediately.
  2. Acceptable Tolerance Limits
    1. QA, in consultation with Procurement and Warehouse Management, defines the acceptable weight discrepancy limit. This limit may vary based on material type (e.g., bulky powders vs. liquid chemicals) or regulatory guidelines.
    2. If the discrepancy is within the acceptable limit, annotate the receiving records accordingly, noting “Within tolerance—no further action” or similar remarks.
  3. Out-of-Tolerance Results
    1. For discrepancies beyond the acceptable range, label the materials as “Under Investigation” and quarantine them. Do not add them to the usable stock until QA completes a review.
    2. Warehouse Personnel must detail the nature of the discrepancy in the remarks section of the receiving register, including the measured weight, expected weight, percentage difference, and any possible reasons (e.g., damaged packaging, shipping error).
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5.4 Quarantine and Investigation

  1. Quarantine Procedure
    1. Move the suspected containers to a designated quarantine area, affixing a “Hold” or “Quarantine” label on each item. Note the date and reason for quarantine (e.g., “Weight Discrepancy”).
    2. Restrict access to quarantined materials to authorized QA or Warehouse staff to prevent accidental use or mixing with compliant stock.
  2. QA Review
    1. QA reviews the receiving documents, supplier information, and any photographic evidence or additional data provided by Warehouse Personnel. Procurement may be contacted to verify the supplier’s declared weights or request clarifications.
    2. QA may instruct additional checks—such as re-weighing using a second, calibrated scale—or request the supplier’s official statement regarding possible shortages or overages. If the discrepancy persists, QA can initiate a formal deviation record.
  3. Discrepancy Resolution
    1. If QA determines the discrepancy is an isolated clerical error or minor shipping variance within revised acceptable limits, the material may be released. Update the Raw Material Receiving Register and remove “Quarantine” labels, replacing them with “Approved” labels.
    2. In cases of significant overage, shortage, or suspicion of tampering, QA may reject the shipment or hold it pending further negotiations with the supplier. Record all decisions in the batch file, along with reasons and any corrective actions taken.

5.5 Approval and Release

  1. Final Authorization
    1. Once QA confirms the weight check is within acceptable ranges or adequately justified, they authorize final release. Warehouse Personnel can then move the approved materials to the designated storage area or production line, updating the inventory management system to reflect the new stock quantity.
    2. If re-weighing or additional documentation clarifies a minor discrepancy, QA notates the resolution in the receiving records. This ensures the audit trail remains clear and traceable for future reference.
  2. Rejected Materials
    1. When QA decides the variance cannot be reconciled (e.g., missing material, potential tampering, unaccounted overage), the shipment or batch is marked “Rejected.” Warehouse Personnel must segregate the batch in a secure reject area to await final disposal or return to supplier.
    2. Procurement, in coordination with QA, may contact the supplier for credit, replacement, or further investigation, depending on contractual terms. Thorough documentation of the discrepancy and resolution process is essential.
  3. Documentation Update
    1. Ensure the Raw Material Receiving Register is finalized with accurate net weights and remarks about the acceptance or rejection decision. Cross-reference any deviation or CAPA documents if the discrepancy triggered a formal investigation.
    2. Maintain copies of all relevant records (POs, supplier weigh tickets, photos, QA approvals) as part of the batch file. Follow the organization’s retention policy to meet regulatory requirements and audit readiness.

5.6 Documentation and Record-Keeping

  1. Raw Material Receiving Register
    1. Document all relevant details in the Raw Material Receiving Register (Annexure-1) for each container or batch weighed, including date, time, container ID, gross weight, tare weight (if applicable), and net weight.
    2. Include any remarks about weight variances or additional steps taken (e.g., re-weighing, photograph, QA notification). Ensure each entry is signed or initialed by the Warehouse Personnel who performed the weighing.
  2. Sampling Log
    1. If any material is flagged for QC testing due to weight discrepancies or concerns about product integrity, record all sample details in the Sampling Log (Annexure-2).
    2. Attach or cross-reference all QC results confirming the material meets or does not meet quality standards. These findings may influence final acceptance or rejection decisions.
  3. Deviation and CAPA Records
    1. Major discrepancies beyond tolerance limits must be managed through the internal deviation procedure. QA documents the findings and initiates CAPA as needed (e.g., supplier audits, revised shipping instructions, or scale re-calibration).
    2. Retain these records in accordance with regulatory requirements, ensuring they are accessible for audits or inspections.
  4. Electronic Systems
    1. If electronic scales interface with a warehouse management system, ensure data integrity standards (e.g., 21 CFR Part 11) are followed. Audit trails and restricted access help prevent unauthorized data manipulation.
    2. Back up electronic records and calibrations regularly, and store them securely for the retention period mandated by company policy or local regulations.
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6. Abbreviations

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)

8. References

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 Measured Weight (kg) Declared Weight (kg) PO Number Remarks
01/02/2025 ABC Chemicals Excipient X Batch EX-2025 501.0 500.0 PO-12001 Within Tolerance
02/02/2025 XYZ Distributors API Y Lot APIY-999 749.5 760.0 PO-12002 Over Tolerance, Quarantined

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 Excipient X Batch EX-2025 John Doe Purity, Identification Pass
03/02/2025 API Y Lot APIY-999 Jane Smith Assay, Moisture 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 baseline procedure for weighing and cross-verifying materials
01/02/2025 2.0 Procedure Enhancement Standardization of Document QA Head All All Added guidelines for electronic scales and revised acceptance tolerances
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