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Launch Party of PS 9000:2011   First IRCA Pharmaceutical Course in Asia	Jul 2011   Aug 2011
No more open book exam-announcement from IRCA	Aug 2011
Introduction to latest PS 9000:2011   CQI Intrduces a new grade of membership   Excipact – a case for excipient audits	Sep 2011    Sep 2011   Oct  2011

Introduction to latest PS 9000:2011

PS 9000 has undergone a major development and the new 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 current 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 new 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.

Launch Party of PS 9000:2011

PS 9000 has been fully revised and was launched as PS 9000:2011 on 14th Sep 2011. The launch party was held in London.

"No more open book exam
Announcement from IRCA"

We have received formal notification from IRCA that they are revising the exams and are going to make them tougher.

The major change is that the 2-hour IRCA set exam will have to be taken closed book. The only thing delegates will be allowed will be unmarked copies of the standards.

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 will have to adopt the new exam moudule after 13th April 2012.

So if you have not made your mind up to complete the internationally recognised QMS auditor/lead auditor course to ISO 9001:2008, and you need to do internal audits, supplier audits or certification audits, it is time to act!