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Wednesday, July 6, 2011

Biological Indicators usage inspection sterile drug manufacturing facility audit questionnaire

Questionnaire for biological Indicators usage, inspection in sterile drug manufacturing facility.

BIOLOGICAL INDICATOR USAGE

1. What type of indicator is used (e.g., inoculated carrier, inoculated product, inoculated simulated product, etc.).?
2. Is the source of the indicator commercial ( what is brand name and manufacturer ) or prepared in-house? (Identify supplier of organism, describe means of propagation and storage, and method of preparation. )
3. What organism is used (specify Genus, species)?
4. What is the challenge level of the biological indicator prior to exposure to sterilant?
5. Does firm verify viable spore count on each lot BIs?
6. Does the firm or the indicator labeling claim to meet USP performance criteria for steam or EtO biological indicators?
7. Does the firm perform USP testing on each lot of BIs received?
8. What is the approximate D-value of the biological indicator?
9. How many indicators are used per sterilizer load?
10. Describe the firm's procedure used to assay the indicators after exposure (i.e., USP, NASA, etc.). (Specify growth media used, optimal and actual incubation time and temperature. )
11. How are the indicators packaged for sterilization?
12. Are these biological indicators located in the most difficult.-tosterilize product sites (explain)?
13. Draw a diagram of the distribution of biological indicators in the loading pattern(s) for the selected drug product.
14. What is the elapsed time (hrs.) between removing indicators from the sterilizer and testing? Are there time limits established for this period? What happens if they are exceeded?
15. What is the average number of sterilizer loads processed per month?
16. How many sterilizer loads with positive indicator test results are there per year?
17. What is the disposition of lots with positive bioindicator tests results (release, relabel, resterilize, destroy, etc.)?
18. Describe biological indicator storage conditions:
a. Type of room, cabinet, etc. (if stored in freezer or refrigerator, state if frost-free)
b. Temperature
c. Relative humidity (if known)
d. Proximity of storage area to sterilizer(s)
19. If biological indicators are used to monitor EtO processes, also describe:
a. The storage history of the particular lot used in processing selected drug product (including dates of lot expiration lot received, lot sampled, etc.)
b. How long has this particular lot been held by the manufacturer?
c. If there a potential for the biological indicators to be exposed to EtO in the environment before use? (If yes, explain)
20. If the biological indicator testing is performed by a facility other than the primary manufacturer, what is the name and address of the facility.
21. Does the firm use chemical process monitor(s) to indicate cycle exposure or to measure one or more cycle parameters? (what is the type, brand name and how used.)
16. How many sterilizer loads with positive indicator test results are there per year?
17. What is the disposition of lots with positive bioindicator tests results (release, relabel, resterilize, destroy, etc.)?
18. Describe biological indicator storage conditions:
a. Type of room, cabinet, etc. (if stored in freezer or refrigerator, state if frost-free)
b. Temperature
c. Relative humidity (if known)
d. Proximity of storage area to sterilizer(s)
19. If biological indicators are used to monitor EtO processes, also describe:
a. The storage history of the particular lot used in processing selected drug product (including dates of lot expiration lot received, lot sampled, etc.)
b. How long has this particular lot been held by the manufacturer?
c. If there a potential for the biological indicators to be exposed to EtO in the environment before use? (If yes, explain)
20. If the biological indicator testing is performed by a facility other than the primary manufacturer, what is the name and address of the facility.
21. Does the firm use chemical process monitor(s) to indicate cycle exposure or to measure one or more cycle parameters? (what is type, brand name and how used.)

Also see
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Process Validation and Drug Quality Approach to Process Validation.

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