TMQA Latest News

MHRA Issues Data on its Assessment of Clinical Trial Applications

The MHRA has issued data this month on the time taken to assess clinical trial applications and substantial amendments. The data summarises the number of applications assessed by the MHRA, split by phase and by commercial versus non-commercial sponsors and provides data on the number of applications approved after first review versus grounds for non-acceptance after first review.

Source:  http://tinyurl.com/om7kqud


MHRA Updates GMP Data Integrity Guidance

In January 2015 the MHRA released a guidance document on Good Manufacturing Practice (GMP) data integrity. An update to this guidance was released this month to include additional clarifications following questions from industry. The guidance sets out expectations for data integrity in GMP and complements existing EU GMP relating to active substance and dosage forms, and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4 . Data integrity requirements apply equally to paper and electronic data. The guidance provides definitions of terms such as ‘raw data’, ‘metadata’, data lifecycle’, ‘audit trail’ and the expectations/guidance associated with each. It gives examples of the varying complexity of systems which may generate data and the inherent risks to data integrity posed by these systems. Although this guidance has been released in relation to GMP, it is worthy of note across the different GxPs.  

Source:  http://tinyurl.com/lqq3ymb


EMA launches anniversary book

An anniversary book to mark 20 years of the EMA has been published.  It aims to capture the changes and progress in medicines regulatory science over the past 20 years, and describe how EMA has addressed important challenges for public and animal health. 

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Vacancy - Quality Assurance Associate

TMQA is a leading international Quality Assurance consultancy working for commercial and non-commercial clients mainly in clinical and non-clinical research and development.  We have a vacancy for a Quality Assurance Associate in our non-clinical division.

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