22-NIH_Supplier_Qualification_Questionnaire_Supplemental.pdf
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- Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
- Solicitation number
- 75N95024R00094
About this file
This document is a supplemental questionnaire for suppliers of sterile drugs, focused on the NIH's evaluation of a supplier's environmental monitoring, media fill, personnel monitoring and qualification, and airflow studies. Key details include:
The questionnaire covers environmental monitoring practices, including frequency, incubation temperatures, and media used to optimize identification of bacteria and mold/yeast. It also asks about aseptic process simulations or media fills, to assess how closely they simulate actual manufacturing operations. The questionnaire inquires about personnel monitoring and gowning qualification, and whether media fills are conducted for initial personnel qualification and annually thereafter. Lastly, it asks if airflow studies are conducted for all biosafety cabinets under dynamic conditions.
This supplemental questionnaire is related to a federal contract opportunity for Chemistry, Manufacturing and Controls (CMC) services for drug substances, to support preclinical and IND-enabling studies for the National Institute on Drug Abuse.
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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?
Attachment 22
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