|
FDA-Drug Manufacturing
Inspections
(Pilot Program)
At FDA the realization has grown that it is no longer possible to
achieve the intensive supervision of all systems and of all processes
every two years. This realization has caused one to start thinking about
how inspections of pharmaceutical companies can be conducted more
efficiently and more rapidly in future. For this purpose, since January
2001 FDA has been testing a new program in 6 US districts for a period of
six months.
With the launch of this program FDA seeks to show the pharmaceutical
companies in workshops what it expects of the program and how the
pharmaceutical industry should prepare itself for this "new"
type of inspection.
In general, FDA pursues two strategies for checking product safety.
- Within the framework of
inspections in the pharmaceutical company
- Inspecting the quality of the
medicinal products
The published guide serves the purpose of establishing the first
strategy. It defines both the two-year inspection and the system-based
inspection.
"System" is defined as the following sectors from the
underlying structure of the cGMP rules.
- Quality System
- Facilities and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory Control System
FDA's idea is that the assessment of the system properties is usable
for the various product classes, for instance in the handling of raw
materials. If in this way the handling of raw materials is judged as
acceptable in a system-based inspection one can assume that the handling
of raw materials is acceptable in all of a company's product classes.
Other examples listed may be the dealing with SOPs or the handling of the
in-process control.
Within the framework of the supervision the inspectors can choose
between a "Full Inspection Option" and an "Abbreviated
Inspection Option". The "Full Inspection Option" comprises
at least four systems, one of which must be the Quality System, while the
"Abbreviated Inspection Option" comprises at least two systems,
one of which must also be the Quality System.
The "Full Inspection Option" is to give a deep insight into
the company's cGMP and is to be used in the following three cases:
- There is too little
information available about the company's cGMP
- One has doubts as to the
observance of the cGMP
- In the past the authorities
have issued orders concerning the cGMP
The "Abbreviated Inspection Option" is to be used in the
following cases:
- The company's cGMP history is
satisfactory (no significant recalls or major deviations)
- The production profile has
not changed greatly during the past two years
You can find further details on the Drug Manufacturing Inspections
(Pilot Program) on the FDA website http://www.fda.gov/ora/cpgm/7356_002/7356-002-Draft.DOC
|
