Biomedical Engineering Reference
In-Depth Information
attachment a
SOP No.:
Issued on:
Revision No.:
Initiator name:
LABORATORIES
1. Are reserve samples of finished products maintained?
2. Have the accuracy, sensitivity, specified and reproducibility of test methods been demon-
strated via validation?
3. Are the QC facilities (building) adequate?
4. Do the facilities have adequate equipment for the performance of QC functions?
5. Refer separate SOP for GLP audit.
6. Are test procedures documented?
7. Are raw material file samples maintained for future reference?
8. Are the laboratory reagents and other chemical supplies identified and the expiration
dated?
9. Are the laboratory instruments requiring calibration maintained according to the calibra-
tion procedures?
10. Is there a written microbial monitoring program for sterile and nonsterile products?
QUALITY ASSURANCE
1. Are the procedures employed by QA documented?
2. Are formal audits of the quality program performed by individuals not having direct
responsibility for the program?
3. Are documented corrective actions taken on noted audit deficiencies?
4. Are the procedures for performing audits finalized?
5. Do written procedures governing a document change control system exist?
6. Is there an adequate recall procedure?
7. Is there an adequate stability program?
8. Is batch record data reviewed on an annual basis to determine continual acceptability of
quality standards, specifications, manufacturing, and control procedures?
PERSONNEL/TRAINING
1. Is there a training procedure for new employees that includes good manufacturing
practices?
2. Is there a refresher training program that includes good manufacturing practices?
3. Are all employees made aware of defects which may occur from improper performance of
their respective jobs?
4. Are written job descriptions available?
5. Are personnel in contact with drugs given physical inspections or periodic health checks?
6. Is there a procedure for the exclusion of ill personnel, or personnel who have open lesions,
from product contact jobs?
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