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...