Somerset House Consultants has recently completed a major project for a US-based contract manufacturer. The company is an established manufacturer of both clinical trial supplies and marketed products for the US market, with a successful FDA inspection record. However, an inspection by European regulatory authorities had found that the company did not comply with EU GMP requirements and could not supply product to Europe.
Over a period of six months, Somerset House Consultants, working with company management, restructured the quality function, resolved GMP deficiencies, carried out mock audits and staff training, and managed the requalification of the facilities and introduction of a risk management programme.
The EMA reinspection was successful. As a result, Somerset House Consultants was also retained to work with their UK subsidiary who had applied for a manufacturers authorisation for their new production suite.
Somerset House Consultants helps contract manufacturers to meet international quality standards and client expectations. We provide quality assurance and qualified person release services for API, IMP and marketed products. Our expert consultants ensure that work is carried out on-time, on-budget and in compliance with all current good manufacturing practice requirements.
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