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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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to be read :
| | Tuesday, June 16th 2009 |  |
| | Monday, September 7th 2009 | |
| | Monday, October 26th 2009 | |
| | Monday, March 15th 2010 | |
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