Preparing for an Audit with Environmental Monitoring Processes

by | Pharmaceutical

Publish Date: February 28, 2022

It’s the laboratory event no one looks forward to: an audit. Undergoing an audit doesn’t have to be scary, however. After all, you’ve got the basics down, like media storage and proper documentation for your samples. You also know what organisms you are going to recover from your facility. But have you considered your environmental monitoring program, from an auditor’s point of view?

An auditor will review your environmental monitoring program to ensure that your processes reliably identify objectionable isolates, allowing appropriate measurement of their risks. Growth Promotion and Sterility Tests “need to demonstrate that media used in the microbiological environmental monitoring program or in media-fill runs are capable of supporting growth of indicator microorganisms and of environmental isolates from samples obtained through the monitoring program or their corresponding ATCC strains.”1

Some of the most common environmental isolates include Micrococcus luteus, Staphylococcus epidermidis, and Bacillus cereus (see Top 10 Environmental Isolates). Isolates like these are commonly brought in unknowingly by laboratory personnel through improper gowning practices, like allowing clothing to touch the floor. Basic techniques like proper gowning will help keep these organisms out of your critical areas. Seasonal changes in objectionable organisms may indicate problems with your air filtration system, allowing influxes of airborne microbes that increase during wetter times of year. Catching isolates before they contaminate your product protects not only the consumers but also your brand image.

In addition to these preventive measures, a robust environmental monitoring program will demonstrate your laboratory’s ability to detect problems that occur despite your safety protocols. The auditor will want to know you are testing for specific organisms with histories of appearing in your laboratory. Make sure you a prepared for questions on your environmental monitoring process by following these simple steps:

Calibrate Your Environmental Monitoring Instruments

Make sure you are accurately monitoring your surroundings by maintaining proper equipment condition. Equipment calibration ensures that your data is accurate, leaving no room for misinterpretation for an auditor.

Log and Trend the Data

Document review of finished recording logs. Auditors will look for management review to see if data is properly analyzed. This review process will also provide insights into trends, like organisms that appear more frequently during specific seasons, for example. You will have a clearer representation if anything is out of normal and may be classified as an objectionable organism. Important information to log includes: frequency of appearance and the CFUs with each occurrence.

Document and Investigate Findings Out of Normal Specifications

Higher CFU count than normal? Be sure to increase routine cleaning and identify any organisms that are not normally recovered. Document these corrective measurements, and continually test for the organism if it is deemed objectionable. QC your media to confirm you can actively recover the organism in question. Confirmation through diligent QC is key for an auditor inspecting your environmental monitoring process.

The auditor is there to make sure your laboratory is following processes and adhering to regulations. Overlooking proper environmental monitoring can add unnecessary stress to an audit. By following the tips in this article, you don’t have to fear the upcoming audit.

USP 42 Chapter <1116> Microbiological control and monitoring of aseptic processing environments.

Written by Microbiologics

Microbiologics is the foremost biological products and services provider, focused on protecting the health and safety of people around the world. For over 50 years, they have been partnering with healthcare and life science laboratories, manufacturers and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics and virology. Headquartered in Saint Cloud, Minnesota, the company has additional facilities in California, Kentucky and Michigan. Microbiologics has advanced industry standards for biological controls by adopting the most rigorous testing and quality standards including ISO 13485, ISO/IEC 17025, and ISO 17034. The company has an extensive distribution network spanning over 150 countries. For more information, visit

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