At the competition, the main factor is serving accurately with expected quality standards and just in time. To achieve this goal, Novagenix determines and analyses accurately all the requirements and expectations of customers, transfers all derived information to relevant departments, plans required processes, determines study and control criterion and methods and follow these, submits the study as it is desired etc.

 Novagenix Bioanalytic Drug Research And Development Center acts on

• ISO 9000 Quality System

• OECD c-GLP

• Good Laboratory Practices

     (published in official journal by Ministry of Health )

ISO 9000: 2000 Quality System describes “quality” as set of structural characteristics’ degree of answering requirements

TS-EN-ISO 9001

Novagenix Bioanalytic Drug Research And Development Center has been certificated with TS-EN-ISO 9001:2000 by Turkish Standards Institute on July 17th 2003.

One of the substantial part of ISO 9001:2000 quality management system’s standards is customer satisfaction.

Novagenix sets up its own quality management system with the object of customer satisfaction improvement by considering all expectations of customers and legal proceedings.

ISO 9001:2000 Quality Management System standards:

Customer satisfaction standards defines proceedings for quality management system with the object of

·         Practicable legal proceedings relevant to product

·         Required process determining with the object of system improvement permanency and coherence to legal proceedings

·         Improvement of customer satisfaction by effective implementation of system.  

Novagenix Quality Policy:

As the creation of Novagenix Bioanalytical R&D Center, the quality of carried out work was concerned dominating and permanent and led us to lay down rules of work in relation to an obligation of ethics, indissociable of our activity.

The purpose of this initiate was, first of all to establish Novagenix Bioanalytical R&D Center a spirit of confidence on emanating work of the laboratory, then to satisfy the requests of our customers in total transparency.

The quality of service rendered by Novagenix Bioanalytical R&D Center passes by understanding of customer wishes, the implementation of the means necessary aiming satisfying the customer and at improving the relations customers/sellers, in the respect and the application of the regulations in force.

The object of the Quality system applied in Novagenix is to improve customer satisfaction according to its quality policy also Novagenix guaranties to carry out ISO 9001:2000 Quality Management System standards’ minimum requirements.

From the beginning quality is admitted as preferential, determining and one of the most important goal of our work and became the main factor that help us to achieve our goals by adhering to ethics.

The goal of this concept is to build confidential business image for Novagenix in the workspace of clinical studies and laboratory regulations and answer our customers’ expectations by adhering to our defined principles.

The goal of Novagenix quality system is

• To serve accurately and give the expected results just in time.

• To standardize all the activities affect quality and transfer all the development to the system

• To keep permanency of the system by debugging unexpected errors and deficiencies

• As a result to improve the customer satisfactory.

Novagenix Bioanalytic Drug Research And Development Center has carried out ISO 9001:2000 Quality Management System standards with the object of getting trustworthy results from accepted projects from the beginning to the end of the study. Novagenix quality system bottoms to keep permanency of activities, detection and prevention of possible inexpediencies and apply the defined methods to prevent errors. Novagenix Quality Hand Book covers requirements of ISO 9001:2000 and summary of quality system and reference to relevant system procedures and directions.

Quality of the service of Novagenix is customer driven. It is important for Novagenix to determine the customer requirements accurately, carry on the necessary applications that meet the customers with their requirements, improve the relationship with customers and suppliers, obey the current regulations and improve the experiences.

At the same time Novagenix can take place and has a good image especially in the international competitive atmosphere with the help of vested quality system.

GLP and OECD c-GLP

The main factor of Novagenix’ s activities is to apply the international norms, GLP and GCP to its national and international clinical studies that include bioanalytical analyses.

• Novagenix serves a compact service includes planning, logistical service, bioanalytical analyses, statistical analysis and computer aided management.

• Novagenix provides the properly transportation of samples and prepares the final report at the desired format by customer and completes on time.

• According to the customers demand, Novagenix transfers the electronic data to the customers.

• Novagenix guarantees to secure all the electronically recorded data.

• Novagenix guarantees to secure all the samples for 1 year and all the relevant documents for 15 years.

Novagenix has been certificated with “Good Laboratory Practices Certificate” and furlough certificate of carry out the bioanalytical studies and report them according to the “Good Laboratory Practices” by Turkish Republic Ministry of Health General Directorate of Drug and Pharmaceutics on January 28th 2000. In addition, Novagenix has been also certificated with “OECD-GLP Accreditation Certificate” by MI Service Group which is an international audit and accreditation agency on January 14th 2003.

 OECD c-GLP

GLP activities have a big role in drug research and development companies. The purpose of GLP is to arrange and secure scientists’ studies according to the science of future. GLP is the guarantee of customer satisfactory, success of security system, data security, accuracy of report and declare reports to authorities. GLP and GCP act like an editor in industry.

GLP’ s main factors:

• Resources; Organization, personnel, applications, equipments

• Rules; Protocols and SOPs.

• Symbols; Test systems and test methods.

• Documentation; Raw data, final report and archive

• Quality assurance department

GLP

Regulations (Instructions) about GLP principles is published in official journal. Novagenix apply these regulations declared by Ministry of Health and Ministry of the Environment and in force. The purpose of these regulations is to determine the procedure and rudiments of GLP principles.

REFERENCE WEB PAGES

http://www.tse.org.tr/