Lot and Batch Testing for release of Over the Counter (OTC) drugs and Pharmaceuticals is vital for products from the initial stages of development through the release of the product into the market.

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Scientech's Batch and Release Tests confirm the purity, potency, and identity of a product.
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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.

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Raw Material Release Testing—Pursuant to 21 CFR 211, Active Pharmaceuticals Ingredients (APIs), and/or Raw Materials must be tested to confirm the identity and integrity of the material. This testing ensures that the API meets the established specifications for its intended use. In-process product testing is vital before packaging the product in the final container closure. Trust the experts at Scientech to provide a quick turn-around time with cost-effective price structuring.

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