Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-004.00 Effective date: mm/dd/yyyy
Approved by:
Bulk release form (completely filled and signed) should always accompany the sample to QC
administration, mentioning the testing required at the stage of sampling.
The QAI makes sure that
1. Containers for sampling are clean and dry or sterile and pyrogen free.
2. Bulk product and container are properly labeled.
3. Documents are as per “checklist for batch documents for bulk product” (Attachment II)
for injection along with required documents to QC.
23.4 reason for revision
First time issued for your company.
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