Batch and Lot Release Potency Testing

Batch and Lot Release Testing ensures that each time an OTC Drug Product is manufactured it meets the established product validation specifications and complies with the requirements and guidelines of the Current Good Manufacturing Practices (cGMP).  Specifically, Batch and Release Tests confirm the purity, potency, and identity of a product. Scientech’s methods are robust and ensure that analytical testing of batches of products meet the quality requirement pursuant to cGMP.  Our scientists follow Verified Compendial Methods, where available, Validate Methods or Verified Client-provided Methods through the method transfer process. Scientech also has experts in Developing and Validating new methods if required.