Attachment24-NIH_Supplier_Qualification_Questionnaire_Supplemental.pdf
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- Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
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- 75N95023R00020
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NIH Supplier Qualification Questionnaire Supplemental Questions for Suppliers of Sterile Drug
1. Environmental Monitoring:
a. Do you conduct environmental monitoring, including dynamic and static monitoring in all classified areas (ISO 5, 7, 8)?
b. What is the frequency?
c. Is USP 1116 followed for EM testing to include incubation at 25C and 35C to optimize identification of both bacteria and mold/yeast? Is both TSA and SDA used?
c. Is EM tracked and trended?
2. Media Fill:
a. Are aseptic process simulations (media fill) conducted?
3. If so does it closely simulate aseptic manufacturing operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations?
4. Personnel monitoring/ qualification
a. Is personnel monitoring conducted to include both observation and microbial (e.g. glove fingertip)? If so, what is frequency?
b. Do you conduct gowning qualification?
c. Are media fills conducted initially as part of personnel qualification and then again annually?
4. Airflow studies
a. Are airflow studies (i.e. smoke studies) conducted for all BSCs under dynamic conditions?
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