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Good laboratory practice and current good manufacturing practice
A comprehensive primer
The challenge is to find a good compromise between not doing enough
and doing too much. Let's take validation as an example. When complying
right at the beginning of the validation process the additional value to
each validation step is tremendous.

However, there is no added value in trying to validate each and every
step and the incremental costs for validation goes up with each validation
effort. The question is: 'where is the optimum' or 'how much validation is
enough'. The challenge is to find the optimum and this requires a thorough
risk analysis. With the help of this primer and listed references it is
hoped that the reader will get enough guideline to find this optimum for his
or her specific process.

Ludwig Huber

Agilent Technologies


On-line resources through the internet keep you up-to-date,
day-by-day!

Paper documents are difficult to update. Therefore we have decided to
update this primer regularly on the Internet. If you want order a printed
version, please refer to the publication number 5988-6197EN.
In addition we would recommend two other important sites where readers
can get up-to-date information:

www.fda.gov
US FDA website.You can find regulations, guidance documents and
warning letters.

www.labcompliance.com
Website dedicated to regulatory and compliance in laboratories. It
includes many links to other websites and has an open discussion forum. It
also includes reference literature and other documents for download.