Deal qualification process for manufacturing

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ensuring GMP compliance why supplier qualification is vital supplier qualification is essential in meeting the requirements of current good manufacturing practices cgmp regulations it is the process of ensuring that suppliers can consistently provide quality materials that comply with current regulations nevertheless qualifying A supplier or contractor is a complex task this video will give you an overview of its relevance in the auditing requirements for initial supplier or contractor qualification the need to qualify suppliers is vital in the pharmaceutical and biotech Industries over the years several famous cases have shown the relevance of controlling the entire pharmaceutical supply chain to assure patient safety to illustrate the problem in 2008 a contaminated Heparin cause to Health crisis in the USA this drug is a blood thinner that 10 million Americans take each year the crisis involved hundreds of patients with adverse side effects and almost 100 fatalities after a complex investigation the FDA discovered that the contamination came from 12 unregulated labs and farms in rural China that were used as suppliers by the API manufacturer the Heparin contamination was especially problematic because it was caused by oversulfated chondroitin sulfate oscs this contaminant can't be distinguished from Heparin with conventional testing this situation could have been avoided by a systematic and thorough supplier qualification Regulatory Agencies have also learned from these cases and demand the qualification of critical suppliers in addition Regulators consider that supplier auditing is a crucial component of the qualification process as it provides a comprehensive overview of the supplier's performance and compliance with cgmp which are the auditing requirements for initial supplier qualification here are the eight most important things to assess from A supplier one verify the supplier's qualifications and experience in the pharmaceutical industry 2. perform a risk assessment of the supplier three review and approve the supplier's quality agreement 4. assess and approve the supplier's quality system to ensure it meets the requirements of GMP 5. confirm the supplier is able to meet regulatory requirements in our customer specifications 6. inspect the suppliers facilities and Equipment seven review the supplier's customer complaints and product recall histories 8. verify the supplier's supplier qualification in conclusion the auditing requirements for initial supplier qualification are crucial to ensure that A supplier is able to consistently meet all the requirements in GMP standards invest in supplier qualification and auditing to ensure that your suppliers are compliant with cgmp regulations join our webinar to learn more tips about handling new supplier and contract manufacturer qualifications as part of your audit program free registration at .qualastory.com