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Quality Assurance or Quality Control?

Quality Assurance or Quality Control?

EU GMP states that Quality Control (clause 1.9) “is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures”.  In essence, QC is a sampling, testing, monitoring and checking activity. GMP also defines the...
Key GMP personnel and their duties

Key GMP personnel and their duties

Some of the most popular articles on our blog are the four we published some four years ago about  key GMP personnel and their duties. These can be found through these links: Part 1 – Production, QC and QP personnel Part 2 – QA personnel Part 3 –...
MHRA publishes new GMP Data Integrity Guidance

MHRA publishes new GMP Data Integrity Guidance

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document published on 23rd January 2015 provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry –...
Management Review – what is it for?

Management Review – what is it for?

In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place. This article has been updated in...