GLP and EN 45001 are internationally recognized quality guidelines and
standards for analytical laboratories. The guidelines of the GLP have
been existing since the end of the 70ths in the U.S.A. and with the e
arly 80ths in Europe and Japan. Several quality oriented laboratories
are GLP certified; GLP studies are recognized in the whole world. Accr
editation or to conform GLP? GLP is restricted to an defined area. Oth
erwise, one free translation of GLP is 'Giant lot of Papers'. The effo
rts for GLP are expensive; most customers are not willing to pay for i
t unless GLP studies are forced by law. The new European Standard EN 4
5001 offers a more suitable, less paper expensive and more content ori
ented quality standard for any kind of physical, technical are analyti
cal kinds of tests. For example, the EN 45001 is widely accepted by th
e European food manufacturers. Differences between GLP and EN 45001 Ac
cording to its individual approach, GLP and EN set up different claims
to their user. GLP requires a perfect documentation of every step of
a study to guarantee a person independent reproducibility. GLP is a fo
rmal quality assurance system. EN requires and proofs the presence of
a formal QS-System and the technical or scientific skill of the labora
tory staff. The EN has been drawn up with the objective of promoting c
onfidence in those laboratories which conform to it.