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The 2006, 38th edition, of the “SFSTP” International Seminar was held in Montpellier France on the 7th and 8th of June.
This international seminar brought together experts from academia, from industry and from regulatory authorities, notably the French AFSSAPS, to reflect on the critical issues of audits and inspections as tools to achieve pharmaceutical compliance and safer, reliable drugs for the patient.
From the many presentations and workshops a clear picture emerged of audits and inspections as compulsory instruments, required by the GMPs and part of the obligations of drug manufacturers as holders of market licenses.
However, in terms of audits, it appeared much less clear how such a regulatory obligation can be translated into the reality of the present day pharmaceutical industry with complex supply situations: there are multiple production sites of excipients and API’s over different continents with trading and repackaging intermediates involved.
From the perspective of excipient and API manufacturers, it is undeniable that there is increased pressure to conduct more audits with more requirements. It is also undeniable that such pressure comes with an increased economic and organisational burden.
Elisabeth Goidin, Quality Assurance Manager at Roquette, presented the situation of a manufacturer not only of API’s and excipients but also of a large variety of other products for the food, feed or chemical industries.
“Roquette pioneered an integrated quality approach as early as the 1970’s. The initiative was taken to have a coherent quality system and ISO was chosen as the common integrating quality system. Today Roquette manages different quality levels, ranging from IPEC inspired guidelines to formal cGMP part 210- 211, and ICHQ7A, all within a corporate ISO umbrella system.”
The diversity that comes from a quality system that has to meet the requirements of many different fields is accepted as an advantage, but of course having to cope with multiple auditing reference texts and requirements represents a challenge to the ISO quality backbone.
Roquette is preparing its organisation for what is described as an expected “avalanche” of audit requests. Solutions to mitigate the economic burden are being taken. Roquette is devising an audit fee scheme to share such costs, while actively encouraging the exchange of audit reports within international groups, the outsourcing of audit activity to recognised service providers and the creation of pharmaceutical auditing syndicates. Roquette’s aim is to continue to provide audit time and resources to satisfy the industry.
This two day international seminar has enabled an in-depth debate around the audit and inspection processes. It was reaffirmed that such instruments are essential,not only to ensure compliance, but also as a means to ensure that drug products are safe and effective for the patient.
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