SOP Guide for Pharma

SOP for Product Identification and Labeling

Auditor

Standard Operating Procedure for Product Identification and Labeling

Purpose

The purpose of this SOP is to establish procedures for the accurate identification and labeling of pharmaceutical products within the distribution facility, ensuring compliance with regulatory requirements and facilitating proper handling and distribution.

Scope

This SOP applies to all personnel involved in the receipt, storage, handling, and distribution of pharmaceutical products within the facility, as well as those responsible for labeling design and regulatory compliance.

Responsibilities

  • The Labeling Manager is responsible for overseeing product labeling procedures and ensuring that labels comply with regulatory requirements and company standards.
  • The Warehouse Supervisor is responsible for verifying product identification and labeling accuracy during receipt, storage, and distribution processes.
  • All personnel are responsible for adhering to procedures outlined in this SOP and reporting any labeling errors or discrepancies to the Labeling Manager or Warehouse Supervisor.
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Procedure

  1. Label Design and Approval:
    • Design product labels according to regulatory requirements, including required labeling elements such as product name, strength, dosage form, lot number, expiration date
      and bar code.
    • Obtain approval for label designs from regulatory authorities and internal stakeholders, ensuring that labels are accurate, legible, and compliant with relevant standards.
  2. Label Application:
    • Apply labels to pharmaceutical products upon receipt, ensuring that labels are affixed securely and in the correct orientation to prevent
miss-identification.
  • Verify label accuracy and legibility before product storage or distribution, checking for any discrepancies between product information and label content.
  • Labeling Verification:
    • Verify product labels during storage and distribution processes to ensure that labels remain intact and legible.
    • Perform periodic checks of labeled products to confirm that labels have not deteriorated or become damaged over time.
  • Re-labeling:
    • If labeling errors or discrepancies are identified, remove and replace incorrect labels with accurate ones, following established procedures for re-labeling and documentation.
    • Document any re-labeling activities, including the reason for re-labeling, products affected, and actions taken to prevent recurrence.
  • Regulatory Compliance:
    • Ensure that product labels comply with all relevant regulatory requirements, including those outlined by regulatory authorities such as the FDA, EMA, and WHO.
    • Maintain records of label designs, approvals, and labeling activities to demonstrate compliance with regulatory standards.

    • Abbreviations

    • SOP – Standard Operating Procedure
    • FDA – U.S. Food and Drug Administration
    • EMA – European Medicines Agency
    • WHO – World Health Organization

    Documents

    Reference documents related to product identification and labeling may include:

    • Label designs and approvals
    • Labeling procedures
    • Labeling verification records
    • Re-labeling documentation
    • Regulatory guidelines on product labeling

    Reference

    Good Distribution Practice Guidelines

    SOP Version

    Version 1.0

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