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This American National Standard (ANS) evaluates various guidance documents, models, and tools to measure and provide a better understanding of quality culture for the pharmaceutical/medical device industry. The standard identifies 5 key focus topics with attributes, characteristics, and measurements …

This standard provides a lifecycle approach using a holistic evaluation of contamination control systems designed to minimize and/or prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient. The standard is also applicable to aseptic …

ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue ProductsThis new standard provides …

This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism. While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction …

ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters addresses the use of virus-removal filters that retain viruses by a size-exclusion mechanism. This document should be considered as a guide intended to provide filter suppliers with an approach …

A standard guidance for the selection and control of suppliers of purchased goods and services that can impact product quality and patient safety. Available to download Format: PDF (1 file 703 KB)Click here to view the digital downloading instruction and Terms of …