Posts tagged ‘ISO’
February 13, 2012
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 below. Those in purple text are requirements of ISO that are not specifially mentioned in EU GMP. From this list you can see that there are a number of areas that ISO covers that are not covered by GMP. Those familair with ICH 10 and the FDA Quality Systems GMP Guidance documents will see how ISO has obviously had an input into the design of these two quality documents. NOTE – THIS ARTICLE WAS WRITTEN BEFORE RECENT UPDATES TO EU GMP CHAPTERS 1 AND 2 AND SO HAS SOME ASPECTS THAT ARE NOW OUT OF DATE.
January 24, 2012
Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions. 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 actually is. This may explain why many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring. Read more