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Asteria Biosystems | AAV Batch Release Review
Asteria Biosystems | AAV Batch Release Review
Fictional-only AAV-26-0811-004 BR-2026-00418
Controlled Document
SOP-QA-014 Rev B
AAV Batch Release Review
Department: Quality Assurance | Status: Effective | Effective: 2026-07-15
Rev B to Rev C Flow
Rev B is the current controlled SOP. Generate Draft Rev C only after the AAV evidence and Maria's exception decision are linked to the process.
Purpose
Define the controlled review process for AAV batch release readiness.
Scope
AAV9-SMA-0426-R batch records, pH trend review, required attachments, exception handling, QA disposition, and release readiness.
Responsibilities
- Senior Batch Review Specialist: Verify batch package completeness and document findings.
- Quality Manager: Review exceptions, approve disposition, and protect final release authority.
- Document Control: Maintain approved SOP revisions and training records.
Required Records
- Batch Manufacturing Record
- pH Trend
- Material Certificate of Analysis
- Equipment Calibration Certificate
- Environmental Monitoring Summary
- Operator Verification
Batch Record Pages
- Page 1: batch identity, lot genealogy, and release target.
- Page 2: bioreactor pH trend with exception marker.
- Page 3: material COA and equipment calibration verification.
- Page 4: operator verification signature field, currently missing.
- Page 5: QA disposition and release authorization.
Procedure
- Confirm batch identity and product.
- Review manufacturing document set.
- Verify required quality checks.
- Confirm pH trend and exceptions.
- Escalate missing operator verification before release.
- Document QA disposition and signature.
Exception Handling
If operator verification is missing or incomplete, hold QA disposition, create a quality exception, route to the Quality Manager, and update the process map before release.
Revision History
- Rev B; 2026-07-15; Current controlled procedure before CaptureFoundry evidence review.
Linked Batch
AAV-26-0811-004