Biomedical Engineering Reference
In-Depth Information
Attachment II
SOP No.:
Issued on:
Revision No.:
Initiator name:
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5. Batch yield at final and at various in-process stages is correct.
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6. Rejection verification of various stages of processing and at final stage.
Injectables
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7. Temperature and pressure differential records.
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8. Sterilization record for machine parts, filters, and gowns.
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9. Ampoule/vials washing and sterilization records.
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10. Filter integrity test report.
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11. Area/equipment clearance (visual inspection).
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12. Visual inspection request.
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13. Print out for leak test performed.
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14. Print out for terminal sterilization (if applicable).
Lyophilized products
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15. Lyophilization cycle chart.
Powder filled vials
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16. Seals/stoppers sterilization records.
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17. Cramper sterilization record.
Any other documents
Reviewed by:
Applicable & available =
Applicable not available =
?
=
Not applicable
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