Up-Scaling and Validation Services
From Oral Formulations
APR manages all steps in the transfer to GMP facility (technical and analytical transfers) and the activities are the following: Up-scaling: Usually, before the preparation of the GMP Batch, it is necessary the preparation of an up-scaled batch. Production of batch according to GMP for clinical purpose: If required a GMP Batch for a clinical purpose is manufactured as well as the formal analytical validations. On the GMP Batch a stability study according to the ICH guidelines is then performed. Validation: is completed with the manufacture of three validation batches.
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