GMP News No. 186
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%)
INSPECTION OF PRODUCTS DERIVED FROM BIOTECHNOLOGIES"