GMP in Biotechnology

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%)

  • 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

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,

Sven Pommeranz


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