Batch release documentation encompasses the thorough compilation of records, reports, and documentation generated throughout the manufacturing, testing, and quality assurance phases for a particular batch of pharmaceutical products. This essential documentation comprises batch records, testing results, certificates of analysis, deviations, and any other pertinent information necessary to validate the release of the batch for distribution, sale, or utilisation. It serves as a comprehensive repository of evidence demonstrating compliance with specifications, quality standards, and regulatory mandates throughout the batch’s lifecycle.
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