Quality control

03
May

We’ll see you at the 2024 FDLI Annual Conference!

Join us at this year’s conference for a great exchange of ideas, and the celebration of FDLI’s 75th Anniversary! Lachman Consultants is excited to be part of the upcoming 2024 Food and Drug Law Institute (FDLI) Annual Conference, scheduled for May 15-16 in Washington, DC. The conference serves as an invaluable platform for professionals across […]

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27
Mar

Will you be joining us at the American Biomanufacturing Summit?

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

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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