USFDA guidance document “Sterile Drug Products Produced by -Aseptic processing Current Good Manufacturing Practices September 2004” states that it is crucial that airflow patterns be evaluated for turbulence or eddy currents that can act as a channel or reservoir for air contaminants (e.g., from an adjoining lower classified area) and that the studies should be well documented with written conclusions, and include evaluation of the impact of aseptic manipulations (e.g., interventions) and equipment design.“
However, recent inspectional trends show that smoke studies continue to be a focus for regulatory inspections and significant observations have been documented in both Form FDA 483 and Warning Letters issued by the Agency. There are some key points to consider for sterile manufacturers conducting these smoke studies.
Daniel J. Roberts, Senior Specialist Pharmaceutical and Biotechnology Practice, has over 18 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was a United States FDA investigator for 8 years including 2 years overseas as the primary point of contact for conducting pharmaceutical inspections at the FDA India Office located at the United States Embassy in New Delhi, India.
As an investigator, Mr. Roberts conducted Pre-Approval Inspections (PAIs) and for-cause investigations and inspections of pharmaceutical manufacturers of human and veterinary sterile and non-sterile finished dosage forms and APIs worldwide. During his tenure at the Agency, he conducted over 100 pharmaceutical inspections as a lead investigator. Mr. Roberts has graduated from the U.S. FDA Biotechnology Partnership training through North Carolina State University where upscale fermentation and bioreactor processes, as well as downstream purification processes, aseptic processing and quality control laboratories were covered. Prior to joining U.S. FDA, Mr. Roberts worked in the biopharmaceutical/biotechnology industry for 8 years specializing in quality control analysis for large molecule biotherapeutics. Mr. Roberts has also worked in scale-up bacterial and yeast fermentation process development to optimize parameters prior to handing over the process to the commercial production operations in a GMP facility.
As a Senior Specialist at Hogan Lovells, Mr. Roberts successfully guides domestic and international clients in the preparation for and management of successful U.S. FDA pre-approval inspections and systems based inspections. He evaluates and assesses pharmaceutical quality systems and specializes in detecting and remediating data integrity concerns and evaluating compliant automated manufacturing process and related computerized systems. He provides guidance and assists clients in responding to FDA-483 observations, correspondences with regulatory agencies, and mock U.S. FDA facility audits.