Analysis of 108 FDA Form 483’s issued to Compounding Pharmacies in 2018 was performed. A textual analysis for the term SMOKE identified approximately 1/3 of the facilities (34) received an observation associated with Critical Airflow Visualization or as commonly referred to as Smoke Studies. Of these, 29 observations were associated with the lack of, improper performance of, or lack of documentation related to dynamic testing. Examples include:
- The dynamic smoke studies failed to incorporate all aspects of the film’s production process.
- Smoke Studies were not conducted during dynamic conditions that fully simulate normal operating conditions of sterile drug production.
- The June 2018 smoke study video for this hood is short, of poor quality and does not demonstrate the airflow pattern under dynamic conditions.
- The smoke studies performed to demonstrate the laminar air flow in the [redacted] in the laminar air flow hood used to produce sterile drug products do not have enough smoke to visualize the air flow.
- Dynamic smoke studies have not been conducted. Smoke studies conducted lack appropriate data necessary for adequate review.
- There is no video, or description provided of the smoke study and no employees of your firm participated or witnessed the smoke study.
FDA’s Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
page 5 states “It is important for area qualification and classification to place most emphasis on data generated under dynamic conditions (i.e., with personnel present, equipment in place, and operations ongoing).” It is under dynamic conditions that tests the air quality under simulated production and is the only test that evaluates the combination of room performance, operator training, and production equipment prior to initial or resuming operation after a maintenance period.
In two instances the firm’s simulated production during dynamic testing was nothing more than the firm’s operators waving their hands and/or arms around to simulate dispensing/manufacturing. No production equipment was present and no routine production was simulated.
The firm producing, manufacturing, or compounding the drug is responsible to ensure the facility, operators and equipment meet cGMP expectations for the appropriate conditions necessary to assure sterility. It does not matter if the smoke testing is done in house, or by a vendor. The FDA expects the facility (The Firms Quality Organization) to understand what was done, why it was done, and be able to provide documentation that demonstrates the room, people, equipment can perform and meet the required ISO conditions. Simply receiving a certification from a vendor that the room passed static and dynamic testing then filing and forgetting about it is not good enough.
Have a question on Smoke Studies at your facility? Performance Validation has over 5,500 hours of experience in planning, executing, and documenting smoke studies. Please use our Contact Us
page or contact or Critical Airflow Services Manger Dalton Pierson
for additional information.