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
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
|
