EXCiPACT has announced the JRS Pharma and Gujarat Microwax (Unit - IV) site in Chandarda District, Mehsana, India has been awarded an GMP certificate from SGS, one of the EXCiPACT’s certification bodies.
The certificate reportedly demonstrates this site manufactures microcrystalline cellulose as a pharmaceutical excipient according to the 2017 EXCiPACT GMP certification standard.
Both SGS and their auditors had to undergo an assessment process to be EXCiPACT registered. Both have satisfied the competency requirements set out in the EXCiPACT annex additional to the ISO/IEC 17021-1:2015 standard. These include completion of its auditor training course, post-course written examination and independently witnessed audit to verify their competency to the required standard. SGS also had to have their auditor’s report verified by their independent certification board prior to issuing the certificate.
EU and US pharmaceutical regulations require drug manufacturers to conduct either their own or third party physical risk assessment audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden. The EXCiPACT certification scheme is designed to help pharmaceutical excipient users and their suppliers to demonstrate commitment to GMP/GDP, to reduce their audit burden, to save costs and to assure product quality.
