Ajinomoto Althea, Inc., a leading provider of biopharmaceutical contract development and manufacturing services, has received European GMP certificate from the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial drug product for the European market. By issuing this certification, the MHRA officially recognizes that Althea's quality control testing and overall quality systems are in strict compliance with the European GMP requirements.
"Althea is proud of this important regulatory milestone. We are well known for our impeccable regulatory track record in the US and now are very pleased to expand our commercial testing capabilities for European clients," stated David Enloe, president and CEO of Althea. "Knowing that our testing and quality processes meet both the stringent FDA and EMA quality requirements really signifies a great accomplishment by our team and supports our leadership position in the CMO market."
In addition to pursuing European GMP approval, Althea continues to invest and expand in quality systems, facilities and operational capabilities to support the increased demand that the company has experienced in both its biologics manufacturing (drug substance) and fill and finish (drug product) business segments. Althea provides a broad range of manufacturing service capabilities including cGMP bulk manufacturing filling in vials and syringes, microbial-based biologics manufacturing, Crystalomics crystal suspension technology, process development, in-process and release testing analytics, equipment qualification, and validation.
The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial drug product for the European market. By issuing this certification, the MHRA officially recognizes that Althea's quality control testing and overall quality systems are in strict compliance with the European GMP requirements.
"Althea is proud of this important regulatory milestone. We are well known for our impeccable regulatory track record in the US and now are very pleased to expand our commercial testing capabilities for European clients," stated David Enloe, president and CEO of Althea. "Knowing that our testing and quality processes meet both the stringent FDA and EMA quality requirements really signifies a great accomplishment by our team and supports our leadership position in the CMO market."
In addition to pursuing European GMP approval, Althea continues to invest and expand in quality systems, facilities and operational capabilities to support the increased demand that the company has experienced in both its biologics manufacturing (drug substance) and fill and finish (drug product) business segments. Althea provides a broad range of manufacturing service capabilities including cGMP bulk manufacturing filling in vials and syringes, microbial-based biologics manufacturing, Crystalomics crystal suspension technology, process development, in-process and release testing analytics, equipment qualification, and validation.
No comments:
Post a Comment