Services - GLP inspections and audits

Context:

Today, most of the studies for regulatory purposes have to be carried out according to Good Laboratory Practice (GLP). It will be done internally if your Company is GLP certified and has got the required techniques, but in most cases it will be sub-contracted externally to a laboratory (Contract Research Organisation, CRO).

The laboratory preliminary audit and the rigorous study monitoring are two essential parameters to ensure studies go smoothly: discussion on the study plan and the associated cost, review of the protocol and its conformity with the relevant guidelines (EPA, EC, OECD, EPPO), Contacts with the Study Director, follow-up of the on-going results and review of the different versions of draft reports until the final report is issued.

Any failure of a study, whatever caused by the laboratory or by an error of monitoring, would represent a big loss of money and a long delay before registration if the study has to be re-done entirely. One should realise that there is no easy study, even the more basic studies can prove to be extremely difficult, or can lead to wrong conclusions if not properly designed.

For a small additional investment, you can have the assurance that your studies will be conducted properly and be delivered on time.

At your request, A.S.C. can:

identify which studies are necessary
advise you in the choice of the GLP Laboratory
carry out a preliminary inspection of a Laboratory, with you if you wish, to check in particular: organisation, technical capabilities, experience and training of staff members, archiving etc…
on your approval of a project plan discuss the guidelines, protocol, time-frame and cost with the Laboratory
maintain a close Contacts with the Study Director, so that there are no delays, and any problems occurring during the study will be dealt with immediately
conduct an audit of the study, if the study is critical for the development of your product.
audit the draft reports to ensure that the final report is precise and follows your needs. Indeed, this report will be the first (and in principle the only) document that the Authorities will have to evaluate the study and ultimately your product. It should thus be as perfect as possible. For each report, A.S.C. will particularly pay attention to:

the format, according to your own requirements and those of the Authorities
check all the calculations, all the data and all internal references
make sure that the presentation of the study correctly reflects the results and that the report is easy to read for the Authorities.

A delay, in any study, for any reason, can lead to the loss of one or more commercial seasons. The investment in the services of A.S.C. to manage your studies brings peace of mind and is by comparison a small price to pay.

Do not take any risks: contact us!