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GMP Calibration

GMP Calibration

GMP Calibration – understand both EU and USA GMP requirements Around a pharmaceutical manufacturing site there will be many measuring devices that require GMP calibration.  GMP requires the calibration of such devices, with similar requirements in both EU and...
CAPA – time for a rethink?

CAPA – time for a rethink?

All manufacturing sites have a CAPA system, usually a mechanism to deal with things that have gone wrong.  Despite the fact that a lot of focus has been given to CAPA in recent years, there is a great deal of misunderstanding and a clear lack of clarity on what CAPA...
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...
Basic audit findings and EU GMP clauses

Basic audit findings and EU GMP clauses

When you are auditing you will often find non-conformities. These occur when the department, process or organisation that you are auditing is not following a requirement of the standard that you are auditing against. For many of you who perform audits in the...