EXCiPACT is pleased to announce that the Hawkins Inc. in Roseville, Minnesota, USA has recently been awarded an EXCiPACT GMP and GDP Certificate from SGS, one of EXCIPACT’s internationally recognized Certification Bodies.
The Certificate demonstrates that this site manufactures, stores, and distributes organic and inorganic salts, acids, bases, and aqueous solutions for use as pharmaceutical excipients, according to the 2021 EXCiPACT Certification Standard for Pharmaceutical Excipient Suppliers.
Both SGS and their auditors had to undergo a rigorous assessment process to be EXCiPACT Registered. Both have satisfied the additional EXCiPACT competency requirements set out in the EXCiPACT annex to the ISO/IEC 17021-1:2015 standard. These include completion of the EXCiPACT Auditor Training Course, post course written examinations and independently witnessed audits to verify their competency to the required standard. SGS also had to have their auditors’ reports verified by their independent certification board prior to issuing the certificates.
For full details of sites currently EXCiPACT certified in 20+ countries (including: Belgium, Canada, China, France, Germany, India, Israel, Italy, Japan, The Netherlands, UK, USA, …), see: http://www.excipact.org/certificate-holders.html
EU and US pharmaceutical regulations require drug manufacturers to conduct either their own or third party physical risk assessment audits of all of their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden. However, using GMP and GDP standards designed specifically for pharmaceutical excipients, EXCiPACT’s voluntary, independent, high quality Certification Scheme helps pharmaceutical excipient users and their suppliers to demonstrate their commitment to GMP/GDP, reducing their audit burden and costs, to assure product quality.
EXCiPACT GMP Certification Press Release: HAWKINS INC. Receives Excipact GMP Certification As Pharmaceutical Excipient Supplier from SGS 1.23.2023