Standard Operating Procedure for Sampling

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for collecting samples for microbiological testing in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the sampling process for microbiological testing within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for collecting samples according to the procedures outlined in this SOP.
• Production Personnel: Responsible for providing samples for microbiological testing and ensuring proper documentation.

Procedure

1. Sampling Plan:
   • Develop a sampling plan outlining the frequency, sampling points, and methods for collecting samples.
   • Consider factors such as production processes, critical control points, and regulatory requirements when designing the sampling plan.
2. Sample Collection:
   • Use sterile sampling containers and utensils to collect samples aseptically.
   • Ensure proper labeling of each sample with relevant information including sample location, date, and time of collection.
   • Adhere to prescribed sampling volumes and techniques to obtain representative samples.
3. Sample Preservation:
   • Preserve samples under appropriate conditions to maintain sample integrity during transportation to the laboratory.
   • Keep samples refrigerated or at specified temperatures to prevent microbial proliferation or degradation.
4. Documentation and Chain of Custody:
   • Document all sampling activities including sample collection, preservation, and transportation in a designated logbook or electronic system.
   • Maintain a chain of custody record to track the handling and storage of samples from collection to analysis.
5. Sampling Equipment Maintenance:
   • Regularly clean and sterilize sampling equipment to prevent cross-contamination and ensure accuracy of results.
   • Calibrate equipment as per manufacturer recommendations to maintain precision and reliability.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Sampling Plan
• Sampling Logbook
• Chain of Custody Records

Reference

United States Pharmacopoeia (USP) General Chapter Microbial Examination of Nonsterile Products: Microbial Enumeration Tests

SOP Version

Version 1.0