{"product_id":"gmp-batch-review-and-release","title":"GMP Batch Review and Release","description":"\u003cp\u003e\u003cstrong\u003eDefines your company's batch review and release process for vendor-manufactured drug product\u003c\/strong\u003e — 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.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWho it's for:\u003c\/strong\u003e Virtual sponsors releasing drug product manufactured by contract manufacturers, where release authority stays with the sponsor rather than the vendor.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eWhat's included:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eFull batch review and release procedure (batch records, Certificate of Analysis, Certificate of Compliance, deviation investigations, change controls)\u003c\/li\u003e\n\u003cli\u003eVendor qualification pathway to Reduced Review status, based on the first 3 batches reviewed\u003c\/li\u003e\n\u003cli\u003eReduced Review procedure and periodic full-review monitoring scheme, scaled to batch volume\u003c\/li\u003e\n\u003cli\u003eBatch Review and Release Form (QA011F1) referenced throughout\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Fully editable Word document (.docx).\u003c\/p\u003e","brand":"FDA-SOPs","offers":[{"title":"Default Title","offer_id":52387179987249,"sku":null,"price":3000.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.fda-sops.com\/products\/gmp-batch-review-and-release","provider":"FDA-SOPs","version":"1.0","type":"link"}