Management Practices for API Manufacturing

Identifying and setting specifications to establish the quality dimensions of a drug substance represents an important aspect of project management. With significant cost and time-to-market pressures, a well thought out strategy regarding a product’s specifications can have huge implications o­n ease of manufacturing and, ultimately, o­n the product’s financial return. The cost of measuring numerous specifications o­n a commercial product is significant. An evolving specification “laundry list” generated during the development process may become “engraved in stone,” incurring unnecessary costs year after year during the product’s life cycle. Surely, this is an undesired situation in today’s cost-conscious marketplace. Therefore, an important project management goal is to establish material acceptance specifications that clearly assess the API’s quality as it is released from a validated manufacturing process.

For full article Click Here