PS... Britain's Best Kept Secret
{"What is the PS series? Why do we need them?" We were asked these questions when we held our first course in Hong Kong recently. We will give you some background to the PS Series, which has been adopted by pharmaceutical companies in EU for supply chain risk management for many years.}
J E M O Limited
Established since 1984

Certification - The Marketing Advantage

There are currently over 100 companies third party certificated to the PS 9000 series and ISO 15378 (a PQG initiative), mainly in Europe, with a handful farther afield, including recent certifications of high profile companies in Asia. With significant increases in pharmaceutical business, many of these companies are now supplying only to the pharmaceutical sector with attendant premium prices. With third party certification by companies such as BSI, Bureau Veritas, SGS, DNV, LRQA and AJA, companies have a unique competitive advantage and are regularly rated as preferred suppliers by the industry

Qualified Auditors

Whilst creating the standards, the PQG recognised the limitations of the existing ISO 9001 auditor certification for pharmaceutical supply chain auditing.  A scheme was created with the International Register of Certificated Auditors (IRCA) for specialised auditor training and qualification. As a provider of this training, JEMO Ltd has run its first pharmaceutical lead auditor course in Hong Kong and is currently extending these through partners in Singapore and Australia.

"The quality of delegates and the interest in the standards was very high." comments Jeff who, with his colleague Lydia Yeh, ran this course. "A number of the delegates were quality directors from major US pharmaceutical companies with regional responsibilities and one was the head of a local pharmaceutical regulator. All of them have expressed interest in sending more people on the courses."

What Next?

The PQG is constantly reviewing and revising its documents and working with international bodies to create world class standards and guides.

PS 9000, first published in 2001 has been completely revised in the light of over a decade of experience. Originally in paper and PDF format, the new standard is a fully interactive PDF with Wikipedia style cross referencing.

PS 9004 is an excellent risk-based guide to implementing PS 9000 and will be revised to match the new PS 9000.

ISO 15378 whilst not a PQG document was created by the International Standards Organisation from PS 9000 with a lot of PQG involvement. This standard applies to contact packaging for both pharmaceutical and medical device products and its architecture has been used as the basis for the new PS 9000.

A recent PQG publication is the Pharmaceutical Supply Chain Risk Management Guide-  

The PQG Guide to Supply Chain Risk Management for the Pharmaceutical and Medical Device Industries and their Suppliers

It provides excellent guidance on reducing the risk of errors in the complete supply chain cycle.

We were involved on the Draft Committes of this.
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Auditor Training, Assessment & Consultancy
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