PS 9000 has been fully revised and was launched as PS 9000:2011 on 14th Sep 2011. The launch party was held in London.
PS 9000 has undergone a major development and the latest version was launched at the Royal Pharmaceutical Society in London on 14th September 2011.
If you have attended one of our IRCA pharmaceutical lead auditor courses you will be familiar with the version which was published in 2001.
If you are not familiar with it, the standard is designed to reduce the pharmaceutical supply chain risks by providing gmp requirements for the quality management of primary and secondary packaging materials.
The 2001 version included the text of ISO 9001 and for copyright reasons this incurred a cost which made the standard quite pricey.
The 2011 version follows the structure and intent of ISO 9001 but does not repeat the ISO 9001 text. Instead it places the requirements in a pharmaceutical context then adds to them with specific GMP requirements. This means there is no ISO copyright costs and the standard is available free from the PQG website. It is also much more auditor friendly.
There are obviously major differences between GMP requirements for secondary packaging and complex primary packaging such as a metered dose inhaler. The new standard covers this by using coloured text. The document is available in electronic or hard copy formats and with the electronic version you can just see the requirements in which you are interested. There is also a Wikipedia style hyperlink to a very comprehensive glossary of terms.
Finally in this brief introduction, there is now significant guidance provided in the standard.
IRCA have revised their exams and made them tougher.
The major change is that the 2-hour IRCA set exam is taken closed book. The
only thing delegates allowed is an unmarked copies of the standard.
Other changes include raising the minimum pass mark in each
section from 40% to 50% and changing the multi-choice section (section 1) to questions requiring short written answers. In short the
exam is going to be quite a bit tougher.
All of the training organisations adopted the new exam moudule after 13th April 2012.
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