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​SGS, a leading certification body for EXCiPACT, has awarded an EXCiPACT GMP certificate to Indorama Ventures' oxides site in Port Neches, Texas, USA.

SGS has awarded EXCiPACT GMP certification to Indorama Ventures’ oxides site in Port Neches, Texas, USA, recognizing the company’s commitment to delivering safe, quality pharmaceutical excipients.

EXCiPACT is a voluntary international certification scheme designed and developed to assure Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards are being used in the manufacture and supply of pharmaceutical excipients. It provides independent third-party certification to manufacturers, suppliers and distributors of pharmaceutical excipients worldwide.

Indorama Ventures received this certification in recognition of its commitment to delivering safe, quality pharmaceutical excipients to the market according to the 2017 EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers the company’s manufacture of propylene glycol, used as a solvent in many pharmaceuticals, from its flagship site on the US Gulf Coast (USGC) at Port Neches.

Supreeya Sansawat, VP, SGS North America & Healthcare-Knowledge Division, said: "We are very pleased to present Indorama Ventures with this well-deserved certification which recognizes their company-wide commitment to providing quality, safe ingredients. It is extremely heartening to see more and more manufacturers stepping up to achieve EXCiPACT certification in support of a global ambition to ensure patient safety through supplier quality.”

Indorama Ventures Integrated Oxides & Derivatives is a leading chemical intermediates and surfactants producer with a diverse range of products in growth markets such as home & personal care, agrochemicals, oilfield technologies, fuel & lube additives and more.

SGS and Indorama Ventures entered a rigorous assessment process to be EXCiPACT registered. SGS has 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 examination and independently witnessed audit to verify their competency to the required standard. The certificate issued by SGS was also verified by an independent certification board before issuance.

For full details of all sites that have been EXCiPACT certified to date in 21 countries (Austria, Canada, China, Belgium, Finland, France, Germany, India, Indonesia, Israel, Italy, Japan, Mexico, Romania, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA), visit EXCiPACT Certificate Holders.

EXCiPACT Services From SGS

EXCiPACT certification enables organizations to demonstrate that their operations meet the minimum GMP and/or GDP requirements for excipients. It also enables organizations to verify the compliance of other actors in the supply chain, reducing the need for duplicate audits to save time and money.

With a global network of experienced auditors, SGS can assess operations against the standards and on successful completion approve EXCiPACT certification, giving access to:

  • A safer, more reliable and transparent pharmaceutical supply chain
  • Cost savings by reducing the audit burden for both customer and supplier without sacrificing quality

The Falsified Medicines Directive in Europe places express requirements on Marketing Authorization Holders (MAH) to assess the GMP used in the manufacture and GDP used in the distribution of excipients by third parties. Organizations achieving EXCiPACT certification can give their clients access to their audit report, as well as any ongoing surveillance activity, fulfilling this requirement. There are similar requirements from the FDA in the USA.

Find out how our pharmaceutical excipient certification services can help your business, visit our website or contact your local SGS office today.

For further information contact:

Jennifer Lott
Pharmaceutical, Cosmetic and Personal Care Technical Director
Business - Knowledge
t: +1 513 630 5988

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.