Dow Chemical Company site in Stade, Germany, has recently been awarded an EXCiPACT GMP Certificate from SGS, one of EXCIPACT’s internationally- recognised certification bodies.
The certificate demonstrates that this site manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers manufacturing of water-soluble methylcellulose and hydroxypropyl methyl cellulose polymers for use as pharmaceutical excipients in the pharmaceutical industry.
Rigorous assessment process
Both SGS and its auditors had to undergo a rigorous assessment process in order to be EXCiPACT Registered. They have satisfied the additional EXCiPACT competency requirements set out in the EXCiPACT annex to the ISO/IEC 17021-1:2015 standard.
In addition, auditors have successfully completed the 2-day EXCiPACT Auditor Training Course and post-course written examination followed by an independently witnessed audit to verify that their competency is to the required standard.
SGS also had to have its auditor’s report verified by an independent certification board prior to issuing the certificate.
Dow's Stade site joins 16 companies that have been EXCiPACT certified to date in countries including:
- Canada
- China
- Belgium
- France
- Germany
- India
- Israel
- Italy
- Japan
- Saudi Arabia
- Singapore
- Spain
- Switzerland
- The Netherlands
- UK
- US
EU and US pharmaceutical regulations require drug manufacturers to conduct either their own or commission third-party physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden.
"Using GMP and GDP standards designed specifically for pharmaceutical excipients, the independent, high-quality EXCiPACT Certification Scheme helps pharmaceutical excipient users and their suppliers to demonstrate their commitment to GMP/GDP, to reduce their audit burden, to save costs and to assure quality," EXCiPACT said in a statement.