A Batch Release Certificate in pharmaceutical manufacturing is an official document issued by a qualified person or authority, confirming that a specific batch or lot of a product meets predefined quality specifications, standards, and regulatory requirements, thereby authorizing its release for distribution or use. This certification is grounded on a comprehensive review and approval of batch records, testing results, compliance documentation, and product characteristics to ensure the batch adheres to established acceptance criteria. The issuance of the certificate serves as assurance to customers, regulatory authorities, and stakeholders of the product’s compliance with necessary quality controls, affirming its safety and suitability for the intended purpose.
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