16. November 2017

Making a case for GMP certification of an excipient manufacturer should be a straightforward exercise since the benefits appear so clear cut and regulatory guidance in the EU underscores the value of certification. Specifically, Chapter 3 of the EMA Guidance on formalized risk assessments to determine the appropriate GMP for a pharmaceutical excipient states that “certification of quality systems and/or GMP by the excipient manufacturer and the standards against which these have been granted...