Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
ANNEXURE C (FOR NONSTERILE)
MANUFACTURING FACILITY
SELF-EVALUATION QUESTIONNAIRE
4th
Quality Control
Yes
No
N/A
1. Is USP organic volatiles and other residual solvents established for
drug substance?
2. Does firm have a SOP for complaints handling, follow-up, documentation,
and preventive action?
3. Are all raw data properly recorded and available for verification?
4. Does the firm have SOP for handling abnormal data?
5. Is the firm capable of performing microbial testing and endotoxin
test for packaging materials?
Comments :
Information provided by:
Designation:
5th
Documentation Control
Yes
No
N/A
1. Does the facility have an adequate system to control specifications, test
methods, and other documents?
2. Are records maintained that identify the reasons for changes
in documents?
3. Are production records retained for adequate length of time?
4. Are employee training records maintained for adequate length of time?
Comments :
Information provided by:
Designation:
Page 5 of 8
 
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