1. Briefly describe the aseptic filling processes from preparation of bulk liquid product to filling and sealing of final dosage form, including the environmental monitoring performed in critical areas during actual production (e.g., how are Class 100 conditions maintained., where are the sampling sites; is bioburden testing performed on the bulk product?)
2. Review monitoring data for several representative months of production, including the period during which batches of the selected drug product were prepared. Were results within specifications?
3. Does the firm have written procedures describing aseptic filling of liquid drug, products?
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4. Is the aseptic filling procedure validated by media fill procedure or other (describe)?
5. If media fills were used, what is the procedures followed and the results, including: number of runs performed; how many vials were filled per run; sizes of vials and fill volume; media used, incubat' periods, temperatures and results ; allowable contamination rate.., and what firm's response was to results that failed established limits.
6. Does the firm provide for periodic monitoring or revalidation of filling lines using media fill procedures?
7. If media fills are used, briefly describe procedure (including frequency; whether performed as its own batch -backed onto a production run; number of vials routinely filled. allowable contamination rate).
8. Review results of media fills performed since last EI (or a minimum of 3 runs, whichever is greater); are results within specifications?
9. What are the firm's specifications and procedures following an out-of-limit media fill result?
10. Are media fills performed on all shifts?
11. Are all personnel included in the media fill program?
12. What system does the firm have for assuring all personnel are included?
13. If end-line filters are used in actual manufacture, are they also used during media fills?
14. What size vial or ampule is used for media fills?
15. Is more than one medium used?
16. Will the number of samples used in a media fill vary from line to line? (If yes, please explain)
17. Are growth promotion studies performed on each type of medium used?
18. Are growth promotion studies conducted every time a media fill is done?
19. When are the growth promotion studies performed (before/after filling; after incubation; etc.)?
20. Is the source of the growth promotion test USP or other (if other, describe, including organisms used)
21. What temperatures and incubation times are used to incubate media fill samples?
22. Are microorganisms from positive vials identified according to genus?
23. Are such microorganisms correlated to those found during environmental monitoring?
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