Standard Operating Procedure for Negative Control

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for maintaining negative control samples to ensure the validity of test results in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the maintenance and use of negative control samples within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for maintaining negative control samples and ensuring proper documentation.
• Production Personnel: Responsible for using negative control samples during testing procedures.

Procedure

1. Selection of Negative Controls:
   • Identify suitable negative control organisms or samples that are free from the target microorganisms being tested for.
   • Verify the purity and absence of microbial contamination in negative control samples prior to use.
2. Storage and Handling:
   • Store negative control samples separately from test samples to prevent cross-contamination.
   • Ensure proper labeling and identification of negative control samples to avoid mix-ups during testing procedures.
   • Handle negative control samples using aseptic techniques to maintain their integrity and prevent contamination.
3. Documentation:
   • Maintain detailed records of negative control samples including their source, preparation, storage conditions, and expiration dates.
   • Document any deviations or incidents related to negative control samples and take appropriate corrective actions as necessary.
4. Verification of Test Results:
   • Incorporate negative control samples into testing procedures to verify the absence of false-positive results.
   • Include negative control samples in each batch of tests to ensure the validity and accuracy of test results.
5. Periodic Review:
   • Regularly review and update the list of negative control samples based on evolving testing requirements and regulatory standards.
   • Perform periodic checks to ensure the continued purity and integrity of negative control samples over time.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Negative Control Sample Inventory
• Incident Reports
• Verification Records

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Attributes of Non-sterile Pharmaceutical Products

SOP Version

Version 1.0