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Establishing an Effective Environmental Monitoring Program

By Tamika Cathey

What Is An Environmental Monitoring Program?

A critical component of preventing product contamination is the establishment of an Environmental Monitoring Program (EMP). This tool enables a detailed understanding the types of contamination, including microbiological, chemical, physical and allergen sources and their levels of contamination activity within a GMP facility.

Monitoring trends using an EMP can then assist in the evaluation of the effectiveness of cleaning programs, personnel practices, and production operations to limit or prevent contamination.

How Do I Establish an EMP?

A risk-based systematic and scientific approach is needed to establish an effective EMP. If implemented appropriately, EMPs act as an early warning sign for the prevention of product contamination. An EMP is a team approach, one in which all parties are operating with an understanding of the applicable FDA regulations and guidance documents. The types of contamination, risks to products, and possible routes of entry should be assessed. Finally, a risk-based facility mapping, and sampling plan must be established, each with threshold limits to ensure identification and quantification will appropriately trigger remediation plans. Let’s look more closely at each component.

Gather an EM team

This should be a committee with subject matter experts experienced in performing risk assessments. The team should include, at a minimum, representatives from Quality, Microbiology, Facilities and Production.

Understand Applicable FDA Regulations and Guidance

Identify all applicable statutes, compendia, regulatory, and/or guidelines based upon product classification, route of administration, and the types of GMP activities performed. Guidance documents that include FDA’s current thinking on EMPs are available for all FDA commodities apart from tobacco. Examples of regulations contained in the Code of Federal Regulations (CFR) include: FDA has stated that it is actively working to establish cGMPs for the tobacco industry which will be know as Tobacco Product Manufacturing Practices (TPMPs). These documents can be useful tools to clarify existing rules and outline regulatory expectations. Risk assessment analysis tools can also be used to adapt portions of the sterile guidelines where regulations for non-sterile manufacturing are not as clear.

Identify Possible Microbiological, Chemical and Physical Contaminants, And Allergens

Identify common types of contaminants that can be introduced to the GMP facility and/or product. Microorganisms such as bacteria, yeasts, and molds, and coliforms as well as pathogens like E. ColiSalmonella, Listeria, and S. Aureus are potential microbiological contaminants; chemical contaminants may include a variety of entities including heavy metals, pesticides, and residual solvents but allergens are certainly a high priority; and physical contaminants such as metal can all be identified from both incoming raw materials and the production process. Compendia sources such as the United States Pharmacopeia (USP), Chapter <2023>, Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements, can provide a framework for microbial attributes for non-sterile nutritional and dietary supplements.

Identify Possible Routes of Contaminant Entry

Routes of entry should also be identified; personnel, equipment, utilities (HVAC systems, for example) and production processes are a few common sources for contamination. A firm’s supply chain can also introduce material and component contamination due to poor GMP practices. Knowing these common routes of entry is the first step in developing a sampling strategy on what to sample for and where to sample throughout a facility.

Conduct a Risk Analysis

A risk analysis is performed to identify all areas of possible contamination. Areas close to critical process, high traffic areas, difficult-to-clean facility locations and equipment, personnel and material flow, and storage areas are all places that can easily be identified by utilizing risk assessment tools like failure mode effects analysis [FMEA], hazard analysis critical control points [HACCP], or Ishikawa [aka fishbone analysis] tables.

Risk assessments should also include cross-contamination​ concernsa rationale for sampling locations, frequencies for each monitored environment, and alert and action levels for each type of potential contaminant.

Develop a Sampling Plan and Mapping Based on Established Guidelines

When selecting sites to be sampled, it is recommended to utilize established guidelines. For example, ISO 14464-1:2015 contains tables to establish the number of nonviable particulate samples based on the size of the room. A common approach in determining where to monitor includes obtaining a map of the area and using the risk assessment results to plot out where the sample(s) should be taken. According to EU GMP Annex 1, “Environmental monitoring sampling plans should be flexible with respect to the monitoring frequencies, and sample plan locations should be adjusted based on the observed rate of contamination and ongoing risk analysis.”

Set Alert Limits

EMP action limits may be implemented and modified from the sterile regulatory guidelines provided in ISO 14464-1, Annex 1, and others such as USP <1116>. Alert limits should be based on historical data and should be used as an alert tool for processes that drift from their state of control.

Statistical analysis can be performed on trend data to establish alert limits as they pertain to process capabilities of the facility. The decision and rationale for the established limits, sampling frequency, and sample sites should then be documented with instructions in a written procedure or standard operating procedure (SOP).

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