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Articles by CMC Compliance

12.03.20 -- Advancing The State Of Aseptic Processing: Let's Get Serious

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By Phil DeSantis, Arvilla Trag, CMC Compliance, Kyle Zingaro
| Pharmaceutical Online Verified
By Phil DeSantis It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination to result in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.
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Good Documentation Practices And Data Integrity: The Conjoined Twins Of Compliance And Good Business Practices

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By Arvilla Trag, CMC Compliance
| Pharmaceutical Online Verified
By Arvilla Trag, RAC, Principal Consultant, CMC Compliance Services Good Documentation Practices and Data Integrity (GDP/DI) are inseparable elements of data management, the foundation of any quality system and are applicable to all departments. While it is possible to have GDP without data integrity, data integrity without GDP is not possible. This provides a sound argument for companies to combine GDP and data integrity into a single SOP and ensure strict adherence to the procedures.
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