SGS India awards EXCiPACT certification to Crest Cellulose Private Limited
SGS India has issued the EXCiPACT Certification to Crest Cellulose Private Limited site in Menakuru Village, Naidupet Mandal, Nellore District in Andhra Pradesh, India. SGS India is one of EXCiPACT’s internationally recognized Certification Bodies authorized to issue this certificate.
The Certificate authenticates that the Crest Cellulose Private Limited site in Menakuru Village, manufactures pharmaceutical excipients in accordance to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. The scope of this certification covers manufacture of microcrystalline cellulose, sodium starch glycolate, magnesium stearate, di basic calcium phosphate, pregelatinized starch, croscarmellose sodium and methacrylic acid copolymer for use as pharmaceutical excipients.
EU and U.S. pharmaceutical regulations require drug manufacturers to conduct either their own or commission 3rd 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 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. On the other hand, this also helps in ensuring patient safety through supplier quality while minimising the overall costs for assessing the excipient supply chain.
SGS and their auditors had to undergo a rigorous assessment process to be EXCiPACT Registered. This included successful completion of the EXCiPACT Training Programme and post-course examination followed by an independently witnessed audit to verify that their competency was as per the required standard. SGS also undertook verification of its auditor’s report by an independent certification board prior to issuing this certificate.
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