In the review of 2017 the main change for MQA was the move at the end of the year to supporting existing and new customers through a full time consulting business. A number of customer audits were successfully delivered and there was increased presence at a number of professional and technical conferences and events.
Of note in 2017 was the annual MHRA GMP/GDP conference that highlighted a number of areas of concern for the regulators including theft and losses, transportation deficiencies and Responsible Person duties in GDP. In GMP, deficiencies in Supply chain compliance, failures in QMS performance and continued issues in data integrity are being seen during regulatory inspections.
Several changes to legislation requirements were introduced including for clinical trials and in addition 2017 saw the long awaited MRA for the EU and USA, updates to the introduction for Serialisation and Annex 1 for sterile products. Not surprisingly Brexit and possible implications for UK Pharmaceutical business continue to be a source of discussion and contingency planning.
In the coming year MQA will continue to deliver professional and technical solutions for clients and if we can assist your business please email us through the web site.
