GMP News No. 186
GMP News 05 April 2002 |
GMP in Biotechnology |
At the end of 2000, PIC/S organised a seminar on the topic "The Inspection of the Manufacture of Biotech Products" for the inspectors of the PIC/S member states in Colmar/France. The speeches can now be read in a volume edited by PIC/PIC/S. One of the speakers was Steve Fairchild, the former head of the Inspection Department of the "European Agency for the Evaluation of Medicinal Products" (EMEA), who gave a report on the "European" Pre-approval Inspections. These are similar to FDA's Pre-approval Inspections and can be requested of the manufacturer of a biotechnological product during the evaluation of the application for an authorisation under the Centralised System. For 60 (!) of the 61 biotechnological products approved between 1995 and 2000 a Pre-approval Inspection on site was considered to be necessary and, therefore, carried out. Apart from the basic steps for getting a centralised authorisation, Fairchild also mentioned the relevant regulations in his speech: EC GMP Guideline, especially with the Annexes 2 and 5, as well as the ICH Guidelines Q5 A, B and D and Q 6B. He distinguished between inspections referring to active ingredients or finished products on the one hand and inspections referring to products/procedures or GMP on the other hand. Illustration 1 and 2 show a classification of the 55 inspections carried out between 1996 and 2000. Ill. 1 Percentage of the types of biotechnological inspections Ill. 2 Geographical distribution of the inspected sites The 180 critical and major deviations found in inspections in 1999 and 2000 referred to: Top group (30%)
Second group (34%)
Others (36%)
Source: "THE
INSPECTION OF PRODUCTS DERIVED FROM BIOTECHNOLOGIES" Author:
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