The award, which is based on the results of a two-day inspection of Grace’s manufacturing facility in Baltimore, Maryland by the International Pharmaceutical Excipients Auditing (IPEA) group, covers the production of pharmaceutical grade silica for excipient applications.
IPEA, an independent subsidiary of IPEC-Americas, deemed that quality management systems, production, management and warehousing procedures at the plant met with current IPEC-PQG GMP guidelines which, although not a legal requirement, indicate Grace's commitment to quality according to company president Grace Davison
Davison said: “Our customers can be assured that we maintain the highest levels of quality,” adding that “we continuously test ourselves and our business process with this audit being an example of that dedication.”
Such efforts to ensure product quality are likely to be welcomed by a pharmaceutical industry that is under pressure to ensure the safety of its products, particularly in the US where groups have issued concerns about excipients sourced overseas.
Need for excipient GMP?
The IPEA's first ever certification is timely given that it follows just a few weeks after EU reignited the debate on the need, or otherwise, for such rules.
A plan to set up GMP rules for certain excipients was dropped by the European Commission (EC) last year on concerns that the requirements were inflexible and likely to damage the industry.
Early last month however, the EC committee on the Environment, Public Health and Food Safety (ENVI), resurrected the debate, suggesting in a draft document that some form of excipient GMP would help in the fight against counterfeit drugs.
The document also called for routine and unannounced inspects of excipient makers, importers and distributors both inside and outside the European Union by third party organisations.