Posts from the ‘Qualified Person’ Category
December 16, 2013
February 14, 2012
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 the same and are not really trying to do the same thing. GMP is a product quality standard, with a focus on getting the right quality product to the only customer of GMP – the patient. ISO 9001 on the other hand is more about running a whole business, a goal of which will be getting product of the right quality – but other aims are important too. Whilst GMP focuses on Production and Quality Control – ISO focuses on the all departments and processes of an organisation. NOTE – THIS ARTICLE WAS WRITTEN BEFORE RECENT UPDATES TO EU GMP CHAPTERS 1 AND 2 AND SO HAS SOME ASPECTS THAT ARE NOW OUT OF DATE.
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 NOTE – THIS ARTICLE WAS WRITTEN BEFORE RECENT UPDATES TO EU GMP CHAPTERS 1 AND 2 AND SO HAS SOME ASPECTS THAT ARE NOW OUT OF DATE.
February 13, 2012
What’s new in the latest version?
The EU GMP Chapter 5 on Production is currently being reviewed. A draft update document is currently available. This article is a commentary on the DRAFT version currently in circulation. Many of the suggested updates are in-line with existing good practices. Some of the main suggested changes are summarised below. You should refer to the actual document, Chapter 5 Draft, for the full details. There is no news on if and when this update comes into force yet. Read more
January 23, 2012
The deadline for public comments on the concept paper on revising EU GMP Annex 16 – Certification by a Qualified Person and batch release is due in just a few weeks. Closing date is 31st January 2012.
Problem statements (from the concept paper)