Sites at Jammu and Khambhat, India, manufacture pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard
Ideal Cures, of India, was recently awarded two EXCiPACT certificates for pharmaceutical excipients by SGS France, one of EXCIPACT’s internationally recognised Certification Bodies.
The Certificates demonstrate that the Ideal Cures sites at Jammu and Khambhat, India, manufacture pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard.
These are the first sites in India to receive EXCiPACT Certification and are the 16th and 17th sites respectively to be certified globally to date. The others sites are in Canada, Belgium, Germany, France, the Netherlands, Saudi Arabia, Spain and the UK.
Both SGS and its auditors had to undergo a rigorous assessment process to be EXCiPACT registered. This required the successful completion of the EXCiPACT training programme and post course examination followed by an independently witnessed audit to verify that their competency was to the required standard.
EU and US pharmaceutical regulations now 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 for excipients, the new, high quality third Party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and assure quality.