Brief Description

This Facility Performance Qualification document is used to confirm that a pharmaceutical area performs properly under normal operating conditions. It checks whether the room is clean and whether important environmental conditions remain within defined limits. The qualification includes testing of air changes per hour, particulate matter, temperature, relative humidity, pressure difference, and air flow pattern. These tests are carried out for three consecutive working days, and some readings are taken at defined intervals. Temperature and humidity mapping help identify minimum, maximum, hottest, coldest, and fluctuating points in the area. Air flow is checked by smoke study to confirm proper movement of air and to ensure there are no dead pockets. Microbiological monitoring is also performed using settle plates and air sampling to check viable and fungal counts. Any deviation, incident, change, or OOS is recorded, followed by recommendations, conclusion, and final approval by responsible departments and Quality Assurance before use.

Impact Assessment

The Facility Performance Qualification will have a positive impact on the controlled pharmaceutical area because it confirms that the facility works properly under normal operating conditions. It checks important conditions such as cleanliness, air changes, particle count, temperature, relative humidity, pressure difference, and air flow pattern. These checks help ensure that the environment remains suitable for routine operations. Microbiological monitoring by settle plate and air sampling also helps control viable and fungal contamination. The tests are performed for three consecutive working days so that the performance of the area can be confirmed consistently.
Any deviation, incident, change, or OOS is recorded and reviewed before final conclusion and approval. This improves documentation, traceability, and control. Overall, this qualification reduces the risk of environmental failure, supports product quality, improves compliance, and confirms that the area is suitable for its intended use.

Questions & Answers

1. What is Facility Performance Qualification?
   Facility Performance Qualification is a documented check to confirm that an area performs properly under normal operating conditions.
2. Why is room cleanliness checked?
   Cleanliness is checked to ensure that the area is visually clean and maintained as per the applicable SOP.
3. How long are the performance tests carried out?
   The tests are carried out for 24 hours for three consecutive working days under operating conditions.
4. What is checked under Air Changes per Hour (ACPH)?
   The number of air changes provided in the room per hour is checked against the specified acceptance limit.
5. Why is particulate matter count performed?
   It is performed to confirm that the area meets the required ISO cleanliness class.
6. Why are temperature and relative humidity mapping performed?
   These studies confirm that temperature and humidity remain within specified limits throughout the area and help identify minimum, maximum, hot, cold, and fluctuating points.
7. Why is pressure difference checked?
   Pressure difference is monitored between the qualified area and adjacent areas to confirm that the required pressure conditions are maintained.
8. What is checked during the air flow pattern test?
   Smoke is used to check that air moves properly from supply to return locations, without dead pockets, and follows the required pressure direction.
9. How is microbiological monitoring performed?
   Microbiological monitoring is performed for three consecutive days using settle plate and air sampling methods.
10. What microbiological parameters are checked?
    Total viable count and fungal count are checked by both settle plate and air sampling methods.
11. What happens if a deviation or OOS occurs?
    Any deviation, incident, change, or OOS is documented in the qualification record for evaluation.
12. Who gives final approval for the qualification?
    After review by the concerned departments and Quality Assurance, final approval is given by the QA Head.