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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOP for Labeling Products and Maintaining Documentation

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Standard Operating Procedure of Labeling and Documentation

Purpose

The purpose of this SOP is to establish guidelines for labeling products and maintaining accurate documentation in the pharmaceutical warehouse.

Scope

This SOP applies to all personnel involved in the labeling and documentation process within the warehouse.

Responsibilities

  • Warehouse Manager: Overall responsibility for ensuring compliance with labeling and documentation SOP.
  • Labeling Personnel: Responsible for labeling products accurately and legibly according to SOP.
  • Documentation Clerk: Responsible for maintaining accurate documentation records in the electronic database.
  • Quality Assurance: Responsible for verifying the accuracy and completeness of labels and documentation.
See also  SOP for Product Sampling

Procedure

  1. Labeling of Products:
    • Ensure that all products are labeled accurately with the correct product name, strength, and quantity.
    • Use standardized labeling formats and templates to maintain consistency.
    • Apply labels securely to product containers or packaging using appropriate adhesive methods.
  2. Documentation:
    • Maintain accurate records of all incoming and outgoing products in the electronic database.
    • Record essential information such as product name, batch number, expiration date, and quantity.
    • Ensure that all documentation is legible, complete, and up-to-date.
  3. Document Review:
    • Regularly review documentation records for accuracy and completeness.
    • Verify that labels match the corresponding documentation entries for each product.
    • Address any discrepancies or errors promptly and document corrective actions taken.
  4. Documentation Storage:
    • Store electronic documentation records in a secure and organized manner.
    • Ensure that documentation is easily retrievable for reference or audit
purposes.
  • Implement backup procedures to prevent loss of documentation due to system failures or data corruption.
  • Abbreviations

    • SOP: Standard Operating Procedure

    Documents

    • Labeling Templates
    • Electronic Documentation Records
    • Corrective Action Reports

    SOP Version

    Version 1.0

    See also  SOP for Operation and Maintenance of Material Handling Equipment
    Good Warehousing Practices Tags:Disaster recovery plan for warehouse, Inventory management procedures, Pharmaceutical warehouse guidelines, Quality control in warehouse, SOP for warehouse operations, Warehouse cleanliness standards, Warehouse continuous improvement, Warehouse emergency response, Warehouse equipment maintenance, Warehouse hygiene practices, Warehouse inventory control, Warehouse maintenance SOP, Warehouse management review, Warehouse product segregation, Warehouse risk assessment, Warehouse safety protocols, Warehouse security breach response, Warehouse security measures, Warehouse SOP, Warehouse staff training

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    Standard Operating Procedures V 1.0

    • Aerosols
    • Analytical Method Development
    • Bioequivalence Bioavailability Study
    • Capsule Formulation
    • Clinical Studies
    • Creams
    • Data Integrity
    • Dental Dosage Forms
    • Drug Discovery
    • Environment, Health and Safety
    • Formulation Development
    • Gels
    • Good Distribution Practice
    • Good Warehousing Practices
    • In-Process Control
    • Injectables
    • Liquid Orals
    • Liposome and Emulsion Formulations
    • Lotions
    • Lyophilized Products
    • Maintenance Dept.
    • Medical Devices
    • Metered-Dose Inhaler
    • Microbiology Testing
    • Nanoparticle Formulation
    • Nasal Spray Formulations
    • Nebulizers
    • Ocular (Eye) Dosage Forms
    • Ointments
    • Otic (Ear) Dosage Forms
    • Pharmacovigilance
    • Powder & Granules
    • Purchase Departments
    • Quality Assurance
    • Quality Control
    • Raw Material Stores
    • Regulatory Affairs
    • Tablet Manufacturing
    • Rectal Dosage Forms
    • Transdermal Patches
    • Vaginal Dosage Forms
    • Validations and Qualifications

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    NEW! Revised SOPs – V 2.0

    • Aerosols V 2.0
    • Analytical Method Development V 2.0
    • API Manufacturing V 2.0
    • BA-BE Studies V 2.0
    • Biosimilars V 2.0
    • Capsules V 2.0
    • Creams V 2.0
    • Elixers V 2.0
    • Ointments V 2.0
    • Raw Material Warehouse V 2.0
    • Tablet Manufacturing V2.0

    New Publication: A must for All.

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