Good Laboratory Practice (GLP) are principles outlining the planning realization, monitoring, documentation, clarification, reporting and archival of the laboratory studies. Principle of Novagenix is to improve the quality of the laboratory and the validation of the methods used by fullfilling the requirements of GLP. By applying the quality control program organized by the quality control department, Novagenix guarantees a laboratoy management in accordance with the GLP for every study.

 1.     Study Protocol

 The protocol contents

·         Aim and organisation of the research

·         Study-time plan

·         Names of stuff responsible for the study and study director

·         Activities of the Novagenix Laboratory

·         Changes related with the protocol

are approved at the beginning of the research

2.     Planning

Realization of the research phase is conducted according to criterions mentioned in the quality hanbook of Novagenix.

Study Director are responsible for

·     General administration of  studies

·    Constitution of raw data

·    Results of analysis, documentation and reporting of the experimental results.

Technical workers with related to research are trained and experienced teorical-practical to observe of procedure and apply methods.

3.     Study notebook

This document contains all of the necessary records showing that the study is performed according to the GLP.

It has been prepared as a list of audit. Analysis and processing of data are documented in every stage.

Data entries and technical observations are recorded. Laboratory Assistances  put the date on this document and sign.

4.     Procedure

Laboratory studies are performed in a specially designed building that is safe and healthy for working persons and environs.

Calibration and daily maintanence of  equipment are made by  Laboratory Assistances periodically.

Reactives, solutions, reference standarts and samples in the laboratory are labelled  with a special code system of Novagenix.

Laboratory studies are carried out according to the Standart Operation Procedures (SOPs) prepared which has been approved by the administration. These SOPs are checked periodically.

SOPs contain technical procedures, principles, methods of analysis, working of equipment, administrating of processing.

5.     Inspection and Validation

Technical personnel pay attention to watch all of parameters that may effect the results. All of the unexpected developments which may effect the validation of studies are presented to the attention of laboratory director and correction actions are planned immadiately and documented. All the raw data, results obtained from samples and quality control analysis are validated by proper standart tests. Besides regular inspections of laboratory, production of unprocessed data and documentation is checked by quality insuarence department. Quality report having inspector signature and inspection date guarantees that the study is performed according to the SOPs and related protocols.

6.      Computer Based Data Production

Computer  based data are transferred via a local computer network. Every data are stored in their own study files. Access to the local computer network is controlled by Novagenix.

7.     Data  Storage

Protocol, processed data, finished study records and other stored records, audit reports of quality assurance unit, final reports are stored in archives room. Archives room is fire protected and allowed entrance is for authorized person only.

Electronic data are protected magnetically and digitally in restricted field. Copies are also stored in a safe place outside the laboratory.

8.     Study reports

Study reports  contain all the results obtained by validated methods. The accordance of the study with GLP is certificated by final report of the study advisor.