Standard Operating Procedure for Microbial Monitoring of Personnel

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish protocols for monitoring the microbial flora of personnel involved in manufacturing processes within the pharmaceutical facility.

Scope

This SOP applies to all personnel working in areas where microbial contamination poses a risk to product quality in the pharmaceutical manufacturing facility.

Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for performing microbial monitoring of personnel according to the procedures outlined in this SOP.
• Human Resources (HR): Responsible for coordinating personnel scheduling and ensuring compliance with monitoring requirements.

Procedure

1. Sampling Plan Development:
   • Develop a sampling plan specifying the frequency and locations for microbial sampling of personnel.
   • Identify high-risk areas and critical personnel involved in aseptic processing or handling of sterile products.
2. Sample Collection:
   • Collect microbial samples from designated personnel using swabs or contact plates.
   • Follow aseptic techniques during sample collection to minimize contamination.
   • Label each sample container with relevant information including the date, time, and location of sampling.
3. Microbial Analysis:
   • Transfer collected samples to the microbiology laboratory for analysis.
   • Plate samples onto appropriate culture media and incubate under suitable conditions for microbial growth.
   • Perform microbial enumeration and identification of isolates using standard microbiological techniques.
4. Data Interpretation:
   • Interpret microbial monitoring results based on established acceptance criteria and regulatory guidelines.
   • Identify trends or deviations that may indicate lapses in aseptic practices or environmental control.
5. Corrective Actions:
   • If microbial levels exceed acceptable limits, implement corrective actions such as additional training, enhanced hygiene practices, or environmental remediation.
   • Document all corrective actions taken and follow up to ensure effectiveness.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• HR: Human Resources

Documents

• Microbial Monitoring Plan
• Microbial Monitoring Records
• Corrective Action Reports

Reference

United States Pharmacopoeia (USP) General Chapter Personnel Qualifications

SOP Version

Version 1.0