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.

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.
4. 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