ABSTRACT
Pharmaceutical customers desire excipients that are produced with minimal variation in quality and performance characteristics from lot to lot as well as within the lot. In addition, pharmaceutical users do not want changes in excipient performance to cause them registration or regulatory issues. Registration issues can arise as a consequence of an adverse regulatory inspection of an excipient manufacturer. Regulatory issues for the drug product manufacturer can result from a significant change that changes the excipient impurity profile or excipient stability and which then alters the drug product impurity profile or stability profile. Thus the excipient customer wants a product that uniformly meets specification and performance criteria and is produced in adequate conformance to regulatory requirements.
