JG BioConsult, LLC

CMC, GMP and Quality Consulting for the Biotech Industry

GMP Production Controls

From a training I did on GMPs for Cell and Gene Therapies.

Defined SOPs are needed for all aspects of GMP production, including cryopreservation.

Deviations, should they occur, must be written, investigated and approved/closed.

Materials and product must be stored at the proper temperatures to ensure quality.

Materials, major equipment and in-process materials must be labeled. Multi-product room should also be labeled.

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