Grace: silica gel plant certification will cut customer audit burden

By Gareth Macdonald

- Last updated on GMT

GRace's Germany plant gets Excipact certification
GRace's Germany plant gets Excipact certification

Related tags International pharmaceutical excipients Pharmacology

WR Grace says certification for its excipient plant in Germany will reduce the audit burden faced by drug industry customers.

The facility in Worms, Germany produces silica gel for drug formulations.

According to Excipact, an independent organisation that certifies manufacturers, suppliers, and distributors of pharmaceutical excipients, production operations at the site are in line with appropriate quality requirements.

Adam Grose, general manager of Grace’s discovery sciences arm, said certification would be valued by the firm’s drug industry customers and the regulators with which they work.

GMP certification is increasingly important in pharmaceutical manufacturing to ensure the highest standards for safety and performance of all ingredients in drug production. Also, this certification removes an auditing requirement, which saves our customers time and money​.”

Certification

The Excipact scheme was developed by the European Fine Chemical Group (EFCG), International Pharmaceutical Excipients Council (IPEC) Europe, IPEC Americas, the European Association of Chemical Distributors (FECC), and the Pharmaceutical Quality Group (PQG).

Excipact is based on standards developed by PQG published as an annex to ISO 9001 and was one of a number of mechanisms developed in response to European and US regulations covering excipients.

Several third-party GMP assessments available for drug excipients: offered by groups including Rx360, Excipact and the USP under its own verification program.

Excipact ‘s certification requires that the auditors assessing each manufacturing site, as well as those reviewing them, be specially trained, and that the audit itself be witnessed by GMP experts.

SGS and blue inspection body were among first services firms to have qualified as Excipact auditors.

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