EMPQ in new facilities: An industry-harmonized approach

Classified environments supporting the manufacture of drug substances and drug products require strict control to minimize the potential for microbiological and particulate contamination of a product.

That is why it is important to have a robust and clearly defined facility-wide process for establishing an environmental monitoring program and its qualification when setting up a new manufacturing facility.

Data from environmental monitoring performance qualification (EMPQ) ensures that the cleanroom environments perform within predefined parameters and provide documented verification that the HVAC system, cleanroom design, cleaning and disinfection program, personnel gowning, material transfer and operation of the equipment are capable of meeting predefined microbial and particulate quality limits.

Our paper provides a comprehensive overview of an EMPQ for new facilities based on industry-led guidance. It offers insights from subject matter experts and includes key elements such as prerequisites for EMPQ, establishing alert levels and action limits, and acceptance criteria.

Performing an EMPQ is an essential part of the contamination control strategy for each of your production facilities. It is a GMP requirement to qualify cleanrooms over the lifecycle of the facility, and any planned changes that may impact product quality must be assessed, including the impact on the qualification status.

How do you perform your EMPQs?