A Quality Manual – what is it and what should it contain?
What is a Quality Manual? A Quality Manual is a document that was first required by the ISO 9001 standard for Quality Management Systems. A Quality Manual is a top-level document that describes an organisation’s Quality Management System (QMS). It can be used both...
Management Review – who, what, where and when?
GMP Management Review meetings The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real...
Standards to use when auditing suppliers
If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. These could be suppliers of chemicals and packaging components, as well as suppliers of analytical testing or calibration services. GMP does not really tell...
The main differences between GDP and GMP
The European Union’s guidelines on Good Distribution Practice (GDP) were updated at the end of 2013. This post covers an overview of the main differences between GDP and Good Manufacturing Practice (GMP). The current GDP guidelines can be found here GDP...
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