This certification against the EXCiPACT GMP standard demonstrates Nitika's commitment to delivering safe, high-quality pharmaceutical excipients to the market. The scope covers the mineral salts, stearates, cellulose and oxide-based compounds, fumarates, carbonates, phosphates, hydroxides, starch, talc, glycols, simethicone citrates, sulphates and croscarmellose sodium used in numerous pharmaceutical products.
Jeff Dowson, SGS Global Head of International Sales and Accounts, commented on Nitika's achievement, and said: "Nitika Pharmaceutical Specialities belongs to the growing number of companies who have been responsive to the refined needs of the pharmaceutical excipient supply chain. We are pleased to be a part of their efforts, reinforcing their demonstration of GMP/GDP capabilities and customer satisfaction. Nitika and SGS both shared a goal of ensuring safety, risk-reduction and quality throughout the process."
SGS and Nitika auditors entered a rigorous assessment process to ensure EXCiPACT registration. The auditors completed the two-day EXCiPACT auditor training course and a post-course written examination to meet the required standard. The certificate issued by SGS was also verified by an independent certification board before issuance.
The EXCiPACT certification scheme simplifies pharmaceutical company audits. As GMP and/or GDP compliance requires more audit burden and effort, this scheme allows drug manufacturers to be compliant through simpler methodologies.
For full details of all sites that have been EXCiPACT certified to date in 16 countries (including Canada, China, Belgium, France, Germany, India, Israel, Italy, Japan, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA), see EXCiPACT website.
For more information, please contact:
Global Head International Sales and Accounts
t: +44 7889 939 725
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 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.