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Congress of Biarritz 2009 - Conference of ending - AFSSAPS

Three themes are approached during the 22nd congress conference of ending, on Thursday, October 22nd: manipulation of highly toxic active principles; management of the corrective actions of the installations of production (correspondence GMP) and finally, the subcontracting of injectable medicines. This last part, presented by Sovannary Gosse, Department Head inspection of the pharmaceutical and biological products - DIE – AFSSAPS articulated in four parts. First of all, the speaker presents the new organization of the leader of the inspection and the establishments with complete slides on all the departments, the organization chart and the missions. The Department of which in the responsibility of Madam Gosse account 22 inspectors (pharmacists), distributed in two units of medicines control.

For the period 2007/2009, they made 380 missions resulting in 1250 reports. The frequency of the inspections of the producing pharmaceutical Establishments of sterile products, the number of which is estimated, in France, at 91 (100 %), is situated between 19 and 30 months. Inside this percentage, 44 % of them are subcontractors. The presentation continues by the characterization of the main distances in the regulations, noticed in the following chapters BPF: 1, Management of the quality (audit of raw materials suppliers, results except specifications, control and liberation according to the requirements AMM); 5, Production (crossed contagions, purchase, liberation of raw materials, approvals of the suppliers); 3, Premises and material (power plant of treatment of air, cleaning of the zones of production to avoid the crossed contagions).

Also let us note distances in guidelines: LD 1, Manufacturing of sterile medicines (plants of treatment and distribution of water, simulation of the processes of aseptic manufacturing and validation) and LD 13 - Qualification and validation (ventilation of premises, decontamination of insulators). Sovannary Gosse indicates then the report between the major distances and the quantity of warnings: 9 for the chap. 1; 8 for the chap. 3; 9 for the chap. 5. For Guidelines: 7 for the LD 1; 1 for the LD 13. All the warnings do not result in formal demands, indeed, on chapters and concerned Guidelines, only 13 were meant. In conclusion, the speaker insists on the evaluation of establishments by an approach of " risk management ", the harmonization of the evaluations through the exchanges during Experts circles PIC/S  ( QRM), Working groups EMEA (texts BPF) and Inspections of the third countries (OMS in particular). Last point: the principal is responsible, the inspection not substituting itself for the audit of a subcontractor.

The morning, quite as the Congress, ends by Gérard Ecotière's intervention, President of A3p. He thanks all the participants, makes an appointment for the 23rd Congress 2010 and invites the last players to put down their quiz (clean and sterile) in urns!


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