The Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), issued in November 2013, mandates that all distributors put into place a Quality Management System that outlines their processes for handling medicinal products.
Having a documented Quality Management System is fundamental to achieving a WDA (H). It needs to contain the firm’s Quality Policy, Management Dedication, Standard Operating Procedures, Risk Assessments, GAP Analysis and Training Records.
We can assess your business and help you to create a Quality System that is in line with the Guidance issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate. This system will detail all necessary procedures and be compliant with MHRA standards
We can help you keep your quality management system up-to-date and adhering to the regulations
We specialise in crafting Quality Management Systems (QMS) customized to your needs, encompassing industry standards such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), ISO 9001, ISO 14001, and ISO 13485. Our profound understanding of regulatory compliance and business intricacies enables us to provide comprehensive support throughout the development and implementation phases, ensuring your QMS aligns seamlessly with the highest standards of excellence.
info@eomisconsultancy.co.uk
01933712313
138 Fitzhugh Rise, Wellingborough, Northamptonshire, NN8 6BU
