GMP Batch Review and Release

Defines your company's batch review and release process for vendor-manufactured drug product — including a risk-based Reduced Review scheme so you're not doing full record review on every batch once a vendor has a track record.

Who it's for: Virtual sponsors releasing drug product manufactured by contract manufacturers, where release authority stays with the sponsor rather than the vendor.

What's included:

• Full batch review and release procedure (batch records, Certificate of Analysis, Certificate of Compliance, deviation investigations, change controls)
• Vendor qualification pathway to Reduced Review status, based on the first 3 batches reviewed
• Reduced Review procedure and periodic full-review monitoring scheme, scaled to batch volume
• Batch Review and Release Form (QA011F1) referenced throughout

Format: Fully editable Word document (.docx).