- OECD Principle of Good Laboratories Practices (as revised in 1997) ENV/MC/CHEM (98) 17,
- Commission Directive 1999/11/EC of 08 March 1999,
- Arrêté du 14 mars 2000 relatif aux Bonnes Pratiques de Laboratoire, Ministère de l'Emploi et de la Solidarité, ISSN 1241-2325 Fasc. n° 2000-5 bis) (J.O. 23 March 2000).
- Principales of GLP to the organisation and management of multi-site studies ENV/JM/MONO (2002) 9.

Quality Assurance Program
to control documentation system (Standard Operating Procedures),
to plan and conduct inspections,
to ensure storage and retention of records and materials,
to ensure quality training of technical staff,
to improve quality system (corrective and preventive actions).
to set up and follow corrective and preventive actions with the Study Director/principal investigator.
to ensure the integrity of the raw data,
to detect deviations from study plan, SOPs and quality system.

Quality Master Plan
The Quality Master Plan at BIOTEC Centre is carried out in 7 steps.

Step 1 : study plan inspection by QAU
Quality report
Signature of the study plan
Start of the study

Step 2 : Meeting for the start of the study with Study Director, technical staff and QAU
Check of "5M"
SOP's to apply
planning of inspection

Step 3 : Quality control during the experiments
Technical staff not involved in the study controls 100 % of the raw data

Step 4 : On-going study inspection by QAU
On critical phases
Quality report
Reporting

Step 5 : End of experiment inspection by QAU
QAU verifies 15 % of raw data
Quality report
Reporting

Step 6 : Final report inspection by QAU
Quality report
Signature of the final report

Step 7 : Storage of records and materials
Ensure by QAU

Technical criteria of Quality
Before starting a study, the concerned technique is validated by :
- Verification of all the criteria of quality,
- Determination of QC samples
The calibration curves with their confidence interval are available every day. At the end of the study,all the calibration curves results are statistically compared to evaluate the reproducibility.

Contacts : Dorothée VIE and Alexandra SCHEEPERS