Category: Deficiencies

  In November 2017, the MHRA released a document that contained deficiency data from inspections carried out in 2016. It included the most common areas of deficiencies found during inspections in relation to the GDP EU Guidance 2013/C 343/01, as well as examples of deficiencies from each chapter.  The data showed that the top deficiency areas…

Wikipedia (other information sources are available, and recommended) states; Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a…

Most of you will be aware of the classes of deficiency that may be discovered during your risk based inspection, but for those who do not, here is a brief summation Critical deficiency: • A “Critical” is deficiency which causes, or leads to a significant risk of causing, a product to be harmful to a…

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