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SOP Guide for Pharma

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SOP for Product Sampling

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Standard Operating Procedure for Product Sampling

Purpose

The purpose of this SOP is to establish guidelines for sampling products for quality control purposes in the pharmaceutical warehouse to ensure compliance with quality standards and regulatory requirements.

Scope

This SOP applies to all personnel involved in quality control activities, including sampling, testing, and inspection of pharmaceutical products within the warehouse.

Responsibilities

  • Quality Control Manager: Overall responsibility for implementing product sampling procedures and ensuring compliance.
  • Quality Control Inspectors: Responsible for sampling products according to established procedures and performing quality tests.
  • Warehouse Managers: Responsible for facilitating product sampling activities and providing support to quality control personnel.
  • Operations Team: Responsible for coordinating product sampling schedules and ensuring availability of samples for testing.
See also  SOP for Warehouse Security

Procedure

  1. Sampling Plan:
    • Develop a sampling plan specifying the sampling method, sample size, sampling frequency, and sampling locations for each product.
    • Consider factors such as batch size, production volume, and risk assessment when determining sampling parameters.
    • Document the sampling plan and ensure that it is communicated to all relevant personnel.
  2. Sample Collection:
    • Select samples randomly from each batch or lot according to the sampling plan.
    • Use appropriate sampling tools and containers to collect samples without contamination.
    • Label each sample with batch information, sampling date, and other relevant details for identification.
  3. Sample Handling:
    • Transfer samples to designated storage areas or laboratories for testing
and analysis.
  • Maintain proper sample handling procedures to prevent degradation, contamination, or tampering.
  • Store samples under appropriate storage conditions until testing is completed and results are recorded.
  • Sample Testing:
    • Conduct quality tests and inspections on samples according to established procedures and specifications.
    • Record testing results accurately and promptly, including any deviations or non-conformances identified.
    • Notify relevant stakeholders of testing outcomes and take appropriate corrective actions as needed.
  • Abbreviations

    • SOP: Standard Operating Procedure

    Documents

    • Sampling Plan
    • Sample Collection Log
    • Sample Testing Records
    • Non-Conformance Reports

    SOP Version

    Version 1.0

    See also  SOP for Returns and Recalls
    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
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    • BA-BE Studies V 2.0
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