The Asha Cellulose site in India has recently been awarded an EXCiPACT Certificate from SGS, one of EXCIPACT’s internationally recognised certification bodies
The Certificate demonstrates that the Asha Cellulose (I) site in Valsad, Gujarat, India manufactures pharmaceutical excipients according to the EXCiPACT good manufacturing practice (GMP) certification standard.
Its scope covers manufacture and supply of ethylcellulose and aqueous dispersion of ethylcellulose for use as pharmaceutical excipients.
EU and US pharmaceutical regulations require drug manufacturers to conduct either its own or commission 3rd party audits of all its starting material suppliers to demonstrate GMP and/or GDP compliance, thus increasing the audit burden.
Using GMP and GDP standards designed for excipients, the independent, high quality 3rd Party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and assure quality.