Environmental monitoring is becoming a major Audit issue since the last decade.

The EM regulatory requirement is changing rapidly for monitoring equipment, data capturing, number of locations as well as monitoring duration. It is moving from random sampling to an automated continuous monitoring system for nonviable count and risk assessment-based selection of the number of locations. The focus is also on non-viable data trending and rational for limit setting.

The expectation is the same for viable count monitoring also and the focus is on viable count data along with the rationale for limit setting.

The EM regulatory requirement focuses on the controlled area with grid distribution in each room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.

A risk assessment rational needs to be developed to determine sampling locations for environmental monitoring. Such risk-based approaches are recommended in ISO 14644-2 which was recently revised & in ISO 14698.

Regulatory authorities like FDA, MHRA & EUGMP are increasingly asking drug manufacturers about risk assessment for sampling locations in EM program.

Risk based approaches include FMEA (Failure Mode and Effects Analysis); FTA (Fault Tree Analysis) and HACCP (Hazard Analysis Critical Control Points), all of which employ a scoring approach. The two most commonly used methods for risk assessment are HACCP and FMEA.

These various analytical tools are similar, in that they involve:

  • Constructing diagrams of work man -material flows
  • Pin-pointing areas of high risk
  • Examining potential sources of contamination
  • Deciding on the most appropriate sample methods
  • Trending to establish alert and action levels
  • Suggest changes to the work process / seasonal activities

These risk assessment approaches are not only concerned with selecting environmental monitoring locations. They integrate the environmental monitoring system with a complete review of operations within the cleanroom to ensure those facilities, operations and practices are also satisfactory. The approaches recognise a risk, rate the level of the risk and then set out a plan to minimise, control and monitor the risk. The monitoring of the risk will help to determine the frequency, locations for and level of environmental monitoring.

GAMP Services offer the following EM services:

  • EM program development, Protocol & SOP review and preparation
  • Regulations and its interpretation
  • Room Classifications -EM Program Misconceptions
  • Risk-based EM
  • Risk Assessment Tool
  • Risk Assessment for the sampling location
  • Data interpretation and limit setting
  • Media selection
  • Training
  • Pre and Post Audit EM related support
  • Smoke study review