Just a reminder that the new EU GMP Chapter 1 on Pharmaceutical Quality Systems and Chapter 7 on Outsourced Acticities come into operation today (31st January 2013). To read my posts on these from last year and to see in actual text click on the links.
If you need any training support for auditing suppliers and pharmaceutical quality systems then visit our web-site for details of our IRCA registered Pharmaceutical Quality Management Systems Auditor/ Lead Auditor training course.
Regards, Dominic
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Most of the new requirements in Chapter 7 are already covered in regulatory inspections. Yet it would be interesting to know if EU inspectors spend a lot of time looking at the new requirments in Chapter 1, especially Quality Management Review and continuous improvement. Will there be differences in approach between the inspectorates of the different EU countries? I am looking forward to seeing the inspection observation trends for 2013 🙂
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