Quality Management Systems Consulting, Auditing and Training Solutions
|
|
Useful Links:
PQG Membership Membership of the PQG is available to anyone with an interest in pharmaceutical matters and can be obtained from www.pgq.org at a cost of £17.50. Several of their publications are available free to members. Included on the site are all of the companies currently certified to the PS series and all of their publications.
|
|||||||||
| News | |||||||||
|
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. For over two decades a group of quality specialists have been creating world class standards designed to reduce the risk of pharmaceutical supply chain errors. Unfortunately few outside Europe have heard of them. In this article, Jeff Monk a member of the Pharmaceutical Quality Group (PQG) of the Chartered Quality Institute (CQI) describes the work of the Group and lets you into the secret of the PS series of standards and other standards they have created. The latest of these PS 9000: 2011 will be launched at the Royal Pharmaceutical Society HQ in London on 14th September this year. Practical Standards For Practical ApplicationsSuppliers And Customers Working Together One reasons for the formation of the PQG was to provide standards which would apply the appropriate level of good manufacturing practice (GMP) to the manufacture and supply of materials and components consumed pharmaceutical companies. Originally focused on packaging, printed components and raw materials, its publications now include a standard for excipients, guidance on supply chain risk assessment and, in association with the International Pharmaceutical Excipients Council (IPEC), a guide for auditing excipient manufacturers. The PQG has strong links with several major international bodies including the International Standards Organisation (ISO) and the World Health Organisation (WHO). Its publications and work are endorsed and supported by the MHRA, the UK medicines regulator. With the involvement of senior quality practitioners from most of the global pharmaceutical manufacturers and people from a diverse range of suppliers, the PQG standards are the result of both sides of the supply chain working together with mutually beneficial objectives. Manufacturers need supply assurance and the suppliers need to implement levels of GMP which are appropriate to their products. The result is standards acceptable to both. Certification - The Marketing Advantage There are currently over 70 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, 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 recently run its first pharmaceutical lead auditor course in Hong Kong and is currently extending these through partners in Singapore and Malaysia. "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 will be 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. It is anticipated that PS 9000: 2011 will eventually replace ISO 15378. A recent PQG publication is the Pharmaceutical Supply Chain Risk Management Guide. This provides excellent guidance on reducing the risk of errors in the complete supply chain cycle. |
|||||||||
|
Jul 2011 Aug 2011 Sep 2011 |
|||||||||
|
PS 9000:2011 has been fully revised and it will be launched as PS 9000:2011 on 14th Sep 2011. The launch party will be held in London. 2. No more open book exam!we have received formal notification from IRCA, 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. The 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 by early 2012 or even earlier. 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 the time to act! PS 9000 has undergone a major development and
the new version will be launched at the Royal Pharmaceutical Society in London
on the 14th of September. 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 intent is to
make the standard available free to members from the PQG
website. It is also much more pharmaceutical focused and 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 will be available in electronic or hard copy formats and with the
electronic version you will be able to 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. The launch will be a significant event in which
you will get the opportunity to see some very professional presentations and
meet some interesting people from the industry and regulator. I hope to see you there. For more information please go to www.pqg.org. |
|||||||||
|