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...
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...
The Focus of Audits – Have we got it right?
Most people will have some involvement with being audited. In general audits are classified into one of three different types; namely first party, second party and third party. First party audits are often called internal audits or self-inspections. Here you are...
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 –...
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We help people in pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
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