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SOP Guide for Pharma

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Capsule Formulation: SOP for Material Handling

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Standard Operating Procedure for Material Handling

Purpose

The purpose of this SOP is to establish procedures for the proper handling, storage, and transportation of materials within the pharmaceutical facility, ensuring the integrity, safety, and traceability of materials throughout the supply chain.

Scope

This SOP applies to all personnel involved in material handling, including warehouse staff, operators, and quality control personnel.

Responsibilities

  • Warehouse Staff: Responsible for receiving, storing, and issuing materials in accordance with this SOP.
  • Operators: Responsible for transporting materials within the manufacturing area following established procedures.
  • Quality Control Personnel: Responsible for verifying the integrity and compliance of materials received and used in production.
See also  SOP for Vendor Qualification and Audit: Procedures for Assessing and Qualifying Suppliers and Conducting Supplier Audits

Procedure

  1. Receive materials in a designated receiving area, checking the accompanying documentation against the purchase order for accuracy.
  2. Inspect materials for any visible damage, contamination, or discrepancies in quantity.
  3. Label materials with unique identification numbers and store them in the designated storage areas according to their specifications (temperature, humidity, etc.).
  4. Regularly monitor and record environmental conditions in storage areas to ensure compliance with material requirements.
  5. Issue materials to production areas based on approved requisitions, ensuring proper documentation and traceability.
  6. Transport materials within the manufacturing area using appropriate equipment, following designated pathways and avoiding cross-contamination.
  7. Use proper handling techniques to prevent damage or contamination of materials during transportation.
  8. Ensure that materials used in production
are within their expiration dates and meet specified quality standards.
  • Dispose of expired or damaged materials according to established procedures and environmental regulations.
  • Regularly review and update the inventory system to maintain accurate records of material quantities and locations.
  • Train personnel involved in material handling on proper procedures, equipment usage, and safety precautions.
  • Implement corrective actions for any deviations or non-conformances identified during material handling processes.
  • Maintain a clean and organized workspace to facilitate efficient material handling and prevent safety hazards.
  • Abbreviations

    No abbreviations are used in this SOP.

    Documents

    • Material Requisition Forms
    • Material Inventory Records
    • Material Disposal Logs
    • Training Records

    Reference

    Good Manufacturing Practice (GMP) Regulations

    SOP Version

    Version 1.0

    See also  SOP for Mixing and Blending Uniformity Test: Sampling and Analysis to Confirm the Uniform Distribution of Ingredients After Mixing or Blending
    Capsule Formulation Tags:Capsule Batch Record, Capsule Blending, Capsule Cleaning Validation, Capsule Coating, Capsule Deviation Investigation, Capsule Dosage Form, Capsule Encapsulation, Capsule Equipment Qualification, Capsule Filling, Capsule Formulation SOP, Capsule Inspection Procedure, Capsule Integrity, Capsule Manufacturing, Capsule Mixing, Capsule Polishing, Capsule Production, Capsule Quality Control, Capsule Sampling, Capsule Shell Inspection, Capsule Weight Check

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    Next Post: SOP for Data Quality Metrics

    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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