Posts from the ‘QMS’ Category
February 25, 2014
Here is a free template for things that you should include in an auditing closing meeting.
- Thank the auditees for their time
- Thank them for allowing you to audit them
- Remind the auditees of the reason for the audit
- Remind the auditees of the standard that you audited against
- Remind everyone that the audit is confidential
- State that you have only looked at a sample of the system
- State if the audit is invalid (you may have needed to see a specific activity and you did not see this)
- Explain how you will present your findings
- Confirm any non-conformities and observations raised
- Provide a closing summary on how the audit has gone
- State your final conclusions of the audit (satisfactory, unsatisfactory, etc.)
- Tell the auditees when they will receive the audit report
- Tell the auditess what they are expected to do once they receive the report
- Allow any questions
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December 16, 2013
February 15, 2012
I perform a number of audits throughout the year. Most are supplier audits but some are internal audits. In order to make the audits as efficient as possible I recommend good planning for the audit – rather than just turning up on the day and “going with the flow”.
Firstly – make contact with your host (auditee) well before the audit. This starts the communication process with them. During this time you can discuss (via telephone or email) any domestic arrangements, such as site location, local hotel, times and dates, etc. From these early discussion an audit programme should be produced and sent to the auditee at least 2 weeks beforehand. This allows them to understand where you are likely to go during the audit.
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.