Attachment23-NIH_Supplier_Qualification_Questionnaire_Supplemental_.pdf
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- Attached to
- Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
- Solicitation number
- 75N95025R00005
About this file
This is a supplemental questionnaire for NIH suppliers of sterile drug products, focused on quality control and monitoring procedures. The questionnaire covers four main areas: environmental monitoring, media fill testing, personnel monitoring/qualification, and airflow studies.
The document requests detailed information about suppliers' processes including: environmental monitoring protocols in ISO classified areas (5, 7, 8) with specific requirements for USP 1116 compliance regarding incubation temperatures and testing media (TSA and SDA); aseptic process simulations and media fill procedures including worst-case scenario testing; personnel monitoring practices including glove fingertip testing and gowning qualification requirements; and verification of airflow studies conducted under dynamic conditions in biological safety cabinets (BSCs). The questionnaire appears to be Attachment 23 related to solicitation 75N95025R00005 for Chemistry, Manufacturing and Controls services for drug product development at NCATS.
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Text version
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?
Attachment 23
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