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Avecia > Biologics > Quality

Quality built in through the life-cycle

Avecia is committed to Quality and cGMP Compliance. Our cGMP facilities are MHRA (Medicines and Healthcare Products Regulatory Agency) approved. Our quality systems comply with the requirements of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002 Part II Basic Requirements for Active Substances used as Starting Materials, and in compliance with ICHQ7a as incorporated in the Federal Register Volume 66 No 186.

The development of processes is well documented, providing the "golden thread" and sound scientific judgement required for all regulatory submissions.

Our Quality System is under continuous assessment through a combination of internal, customer and regulatory authority audits. We are committed to helping our customers to meet their product goals and provide regulatory support, including assistance with the compilation of relevant sections of a regulatory submission.

 


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The Avecia difference - Quality

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