Raising non-conformities
Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit. This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have...
ISO 9001 versus GMP – Part 2
A lot has been said about ISO 9001 in the pharmaceutical industry. This article tries to compare the two fairly. You should read Part 1 first to get some idea of the differences. One of the main problems of comparing GMP and ISO is that the two standards are not...
ISO 9001 versus GMP – Part 1
A lot has been said about ISO 9001 in the pharmaceutical industry. With pros and cons and comparisons to GMP made all the time. This will be discussed more in a later article, but as a starter I have listed the clauses of ISO 9001:2015 below. Those in green text...
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...
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