Quality control

Lachman Consultant Services, Inc. / Blog / Quality control
27
Mar

Will you be joining us at the American Biomanufacturing Summit?

By    Mar 27, 2024    Bioanalytical Biologics Emerging Technology Manufacturing News Pharmaceutical industry Quality Quality control Quality issues Regulatory Affairs Regulatory intelligence

You’re invited to visit with Lachman at Booth #47. We hope to see you at the 10th Anniversary American Biomanufacturing Summit, one of the can’t-miss events of the year. It’s taking place on April 10-11, 2024, at the Hyatt Regency San Francisco Airport, San Francisco, CA. The American Biomanufacturing Summit is one of the most senior-level […]

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30
Aug
Quality Agreements Image

The Role of QC Testing

By    Aug 30, 2022    Compliance FDA Quality control

The EU recently issued the comprehensive GMP Annex 1 for the manufacture of sterile drug products. This guidance is broad and thorough covering all aspects of sterile product manufacture. Under the Quality Control section, (10.5) the following is referenced: The sterility test applied to the finished product should only be regarded as the last in […]

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