Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
ANNEXURE D (FOR STERILE)
STERILE BULK MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE
9th
Sterile Bulk Manufacturer
Yes
No
N/A
1. Does the company have flowcharts with the major processing steps
(including impurity)?
2. Does the company have piping system diagram for all utilities
(e.g., WFI, clean steam, gases, etc.)?
3. Does the company have product validation reports for drug substances
(all parts, process variables, phases, steps, fluid pathway, time limitation study)?
4. Are aseptic operations performed by operator?
5. Is culture media or nonmedia an alternative used to assure assessment
of sterility for the aseptic process validation?
a. Is validation close to current practices?
6. Is environmental and personnel monitoring performed during validation
to establish limits?
7. Are aseptic operations performed in a closed system?
8. Does the company monitor bioburden of nonsterile critical
components and of operational steps?
9. Does the company have endotoxin removal validation report for the
manufacturing process?
10. If yes, does it contain endotoxin level monitoring of starting components?
11. Is endotoxin removal validation for conversion from nonsterile to
sterile performed with
a. Laboratory/pilot-scale batches
b. Production batches
12. Does aseptic processing facility include temperature, humidity,
and pressure differential control for different class area?
13. Does the company have routine environmental monitoring program?
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Page 12 of 15
 
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