Untitled

20 International Regulations
INTRODUCTION
Albrecht Killinger
Uhde GmbH, Biotechnology Division, Leipzig, Germany
Joachim Hö ller
Boehringer Ingelheim Austria GmbH, Vienna, Austria
This chapter outlines the regulative requirements concerning cleaning in the
pharmaceutical industry for non-U.S. countries including the European Union
(EU) (France, Germany and the U.K.), and Japan.
In general, the regulations for the life cycle of apharmaceutical drug are based
on abody of rules known as Good Manufacturing Practices (GMPs). These rules
describe the manufacturing requirements to produce quality pharmaceutical
products.
TO UNDERSTAND GMP
The GMP concept is based on the idea that all drug manufacturing activities should
lead to aproduct, meeting its pre-determined specifications and quality attributes.
As the pharmaceutical entrepreneurisresponsible for specifying his product and as
he is the process owner, heisthe only one who knows, based on arisk assessment,
what is necessary for the intended use. The GMPs therefore contain only performance
criteria and rely on the entrepreneurtodocument in which way and through
which technical specifications he and his process achieve the required performance.
Deviations from the pre-determined specifications can occur through
contamination of the product from two sources:
& Contamination from the environment due to insufficient cleaning of the
rooms and
& Cross-contamination fromthe process equipment by residues fromthe previous
batch due to insufficient cleaning of the equipment.
Cleanability and cleaning procedures are therefore acentral and major concern of
the GMP.
HISTORY
The Canadian Specifications Board of the Supply and Services Department issued
the first modern code that could be considered as GMPs in 1957. Soothe success
of the regulations stimulated the launch of GMP by regulatory agencies at arapid
pace and by the beginning of the 1980s, morethan 20 countries had issued their own
regulations. These GMPs show an almost uniform world-wide content and style
except in Japan where they reworked their rules in 2002. (Prior to that time, the
Japanese regulations contained more detailed job descriptions with duties and
responsibilities of the staff inapharmaceutical company.)
361