The new regulations and the effectiveness of pharmacovigilance put pressure on pharmaceutical packaging, leading to the proliferation of checkpoints on the packaging lines.
Increased yields are requested for personnel, whose tasks are more complex production. It becomes imperative to promote the ownership and control systems to avoid spreading.
Control Technology in line with these changes, switch to CIP13 - Datamatrix on 01/01/2010 and anticipation of the inexorable trend towards greater control and traceability.
The number of alerts to the AFSSAPS quadrupled in 7 years - 253 cases in 2000 to 943 in 2006. Only the year 2007, with 930 reports, seeing some stabilization. Over the period, the number of withdrawal of the lot, between 39 and 60 cases per year has remained relatively stable in absolute terms.

A proof of the increasing effectiveness of the drug and the overall progress of the pharmaceutical quality. But a shadow is to the table: the very few published statistics on the subject (*) we can say that the majority of reports is due to defects in packaging.
There are several reasons for this:
- Industrial change experienced in the pharmacy for 15 years - mega - development of generic drugs - opening new markets.
- Production sites have specialized in formulation and increased productivity. Today, packaging workshops dealing with the proliferation of presentations, the fragmentation of the lots, the format changes frequently and most diversified packaging.
- The staff is reduced to an optimum level and is increasing its tasks, which may be offset by the formation of men and technology available.
Developed specifically for the pharmacy, in strict compliance with the norms and standards (GAMP, 21 CFR ... P11), the Web Technology takes into account the constraints imposed on industry to control online packaging of their medicines. Standard architecture allows the coexistence on a packaging line of checkpoints heterogeneous (cameras, scanners laser marking systems ...). A single operator interface centralizes, stores and monitors all parameters of the control line. This modular architecture provides a stable and painless change, adding an additional component does not affect the stability of existing systems, thus avoiding its requalification. Its architecture is scalable to infinity, neither the quantity nor the nature of the control points are limited. Lastly, the changes in format and the stability parameter record are controlled.
The Web technology, scalable, modular design takes into account the economic industry, for which a capital good is acquired for a period of minimum use of 10 years, with regulatory changes, strategic or economic uncertainty.

The safety of pharmaceutical packaging, recent regulatory developments in French and converge to the line marking the entries in the form of Datamatrix codes. To secure the supply chain of the drug, the evolution towards traceability serial number of each box seems inexorable, with a rate of change in each country. But the company must itself adapt to the markets it serves.
The Web Technology allows it to invest only in what it needs at any given time without cutting opportunities for future developments.
In France, regulation of AFSSAPS 16/03/2007 on the passage of the CIP from 7 to 13 characters and it can be marked as a Datamatrix code may be applied to the packaging lines with the web technology. Its standard configuration can change at any time to the serialization and filiation and allows you to associate a marking system to a camera control that ensures, so infallible, that only cases of a marked Datamatrix line will be placed on the market .
The risk of error increases with the complexity of packaging, the packaging lines must have control systems reliable and easy to use. The Web Technology meets these objectives because the quality of packaging will never cease to be, for the pharmaceutical industry, an important issue.
(*) In 2003, 54% of the alerts to the AFSSAPS were due to defects in packaging. (Seminar SFSTP-2004, Montpellier)
Bibliography:
- Annual reports from Afssaps 2000 to 2007
- J.O. of 16/0307: Notice to holders of MAs
- Decision of the California State Board of Pharmacy, pursuant to Business & Professions Code Section 4163.5, 25/03/08
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to be read :
| | Monday, August 31st 2009 |  |
| | Monday, October 26th 2009 |  |
| | Monday, February 1st 2010 |  | |