Software simplifies cleaning validation for API manufacturers

Specialty solutions provider, Quascenta, has released a software application, eResidue-API, designed to specifically to help active pharmaceutical ingredient (API) manufacturers streamline the cleaning validation process.

Replacing the traditional spreadsheet format, the software is claimed to provide a platform that stores equipment and product related data, as well as allowing users to perform multiple calculations based on site requirements.

The software has been developed in collaboration with Destin LeBlanc, the chair of the Parenteral Drug Association (PDA) task force and an expert in the area of cleaning and cleaning validation. It has been built on the existing eResidue platform and offers several features, such as the ability to use dose or health based values as a basis, role-based access, 21 CFR Part 11 compliant audit trails and electronic signatures.

“eResidue for API is the first and only solution for cleaning validation residue limit determination designed around the requirements of API manufacturers”, commented Ravi Moorthy, president of Quascenta. “Our customers can finish the qualification and start using the application within a week, without lengthy implementation cycles that are typical in desktop based applications.”