GMP in Biotechnology

 GMP in Biotechnology

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%)

• Equipment design and maintenance
• Documentation - procedures and quality system

Second group (34%)

• Process validation
• Microbiological contamination
• Environmental control
• Starting-packaging materials control
• Equipment validation

Others (36%)

• Product testing - batch release
• Control of processes and environment
• Cleaning validation
• Product segregation and identification
• Matters concerning personnel (hygiene, training, duties)
• Documentation
• Self-inspection, investigation of anomalies
• Regulatory non-compliance

Source: "THE INSPECTION OF PRODUCTS DERIVED FROM BIOTECHNOLOGIES"
The collected papers from the French Agency for the Safety of Health Products (AFSSAPS) presented at a Seminar held in Colmar (France) from 25 to 27 October 2000.
Published by the Secretariat to PIC/PIC/S, www.picscheme.org

Author: 
Sven Pommeranz
CONCEPT HEIDELBERG