Quality Assurance Milestones at Cormica – 2024
31/07/2024

At Cormica, we are dedicated to improving patients’ lives by providing comprehensive testing services to Combination, Medical Device and Pharmaceutical manufactures so they can launch and release their critical products safely and rapidly across the world.

Cormica offers a wide range of critical testing services, including chemical and physical analysis, microbiological and sterility testing, biocompatibility testing, performance, verification, validation, ageing, transit and package testing. Our laboratories are accredited by leading regulatory bodies such as the FDA, MHRA, and UKAS, reflecting our dedication to quality and continuous improvement.

MET Achieves First-Time FDA Inspection Success

We are thrilled to announce that MET has successfully passed its first FDA inspection for batch release testing, achieving a result of NAI (No Actions Indicated). This accomplishment reflects our team’s hard work and adherence to Good Manufacturing Practice (GMP) principles. Additionally, MET maintained its continuous accreditation with a successful UKAS audit in March 2024.

Medical Device quality Assurance at Cormica

Cormica Bradford’s GLP Compliance

In February 2024, Cormica Bradford hosted a successful Good Laboratory Practice (GLP) inspection by the MHRA, marking our third inspection since 2018. This complements our longstanding GMP accreditation and underscores our ability to support customers through various stages of product development, from early-stage characterisation to batch release and stability testing.

Wickham Micro’s GLP Compliance

Wickham Micro received the MHRA GLP Statement of Compliance, highlighting our rigorous quality assurance processes, including procedural inspections, report reviews, and facility audits. Our independent Quality Assurance Unit ensures all activities meet the highest standards, maintaining an audit-ready facility at all times.

TPM Labs’ Consistent GMP Excellence

TPM Labs continues to excel with its GMP compliance, having been inspected by the FDA seven times with all inspections being 483 free. This consistent performance demonstrates our robust quality assurance processes and unwavering commitment to excellence.

These accomplishments across our Cormica laboratories demonstrates our overarching commitment to quality. We continually strive to improve our processes and uphold the stringent requirements set by global regulatory bodies. Our clients can trust that every test conducted at a Cormica lab is performed with the utmost precision and care, ensuring safety and efficacy in the products they bring to market.

We are proud of the recent successes at MET, Cormica Bradford, Wickham Micro, and TPM Labs, and we remain committed to excellence in quality assurance.

For more information contact our expert team on sales@cormica.com

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