Quality System Manual

Quality System Overview

Gentaur is a company, focused on distribution of laboratory reagents, equipment and customized services for the needs of research centers, university laboratories, diagnostic laboratories as well as biopharmaceutical and biotechnology industries. The products that we supply are used by our customers for research, R&D, monitoring, diagnostics, quality control and manufacturing purposes.

Certain products and product lines that we supply are manufactured in accordance with the GMP requirements, others may be produced in a GMP format should need be. In the latter case the GMP format should be specifically requested prior to ordering. Almost all the products that we distribute are manufactured by companies certified in ISO9001 or a similar quality management system. Our manufacturer evaluation and choice together with the established internal procedures that we follow, and a quality philosophy based on continuous improvement of our services are the framework of our quality system. Strict adherence to this system enables us to deliver high quality services and products to our customers.

With over 600 partnering manufacturing companies and laboratories, Gentaur is a recognized leader in providing full solutions for every type of laboratory. Our team consists of biologists and biotechnologists with scientific background and years of experience in the commercial market of laboratory consumables and services. Our representatives are able to provide the customers with comprehensive comparative lists of products and manufacturers and help them make a well informed decision in favor of the best suited products for the customers’s needs.

 

Quality System Details

Strategic Plan and Management Review

Being a highly specialized privately held company, all major decisions in Gentaur are made at the top of the organization by the CEO and President of the company. Minor issues and decisions are taken by the managers of the respective departments. Our quality system is continuously evaluated and adjusted to ensure our objectives of service and product quality, continuous improvement, and customer satisfaction are achieved.

Corporate Organizational Chart

Corporate Organizational Chart

Document Control

The Quality unit is responsible for controlling the issue, distribution, revision, and archiving of documents. All policies, procedures, and forms are maintained under document control. Formal change procedures are used for creating new documents and revising existing documents.

Training

It is our policy to hire only qualified personnel and to assure that they are trained in all aspects of their jobs. Each position has a written job description that describes the necessary educational and experience qualifications to adequately perform the required tasks. Our established training program includes both core and job specific requirements as well as a set of hard and soft skills. Supervisors are responsible for job-specific training, for training on new or revised documents, for assuring that training is effective, and for maintaining training records. The entire personnel periodically participate in trainings, structured in a manner relevant to each department’s activities and responsibilities, that aim to ensure a better understanding of the new products and technologies. Records on all trainings are maintained and available.

Corrective and Preventive Action

Corrective and Preventive Action procedures are used to identify areas for improvement to current services and processes and to implement actions that will prevent issues from reoccurring or happening at all. Records of taken corrective and preventive actions are maintained and available.

Customer Complaints

Customer complaints are recorded and processed in a timely manner. Management reviews complaints to determine the necessary investigation and ensure resolution. Procedures define how complaints are investigated and, when applicable, the corrective and preventative actions that are implemented.

Audits

Internal audit programs have been established at to ensure the integrity and continuous improvement of the quality system. The scheduled audits are performed twice a year and, should need be, unscheduled internal audits may be performed at any time to ensure the proper functioning of the company.

 

Supply Chain, Product Certification, Origin and Labeling

Suppliers / Manufacturers

Our suppliers/manufacturers (products & services) can be qualified using a combination of criteria such as, assessment questionnaires, on-site audits, historical performance (quality, on-time delivery) and/or third party accreditation. A supplier/manufacturer may become "Rejected" after non-compliance with our quality expectations. New and alternate suppliers are qualified as necessary to maintain product range, supply, and competitiveness.

Almost all our supplier companies are certified in ISO9001 or a similar quality management system. The quality management system according which each manufacturer/supplier operates is individual and information regarding it is available in the technical sheet of each product or upon request.

Product Certification, Origin and Labeling

Certain products and product lines are manufactured in accordance with the GMP requirements, others may be produced in a GMP format should need be. In the latter case the GMP format should be specifically requested prior to ordering. Certain products and product lines are approved for in-vitro clinical diagnostics and others are intended solely for research purposes. Information regarding the application(s) is provided in the technical sheet of each product. None of the products distributed by Gentaur is to be used for human or animal consumption or as a medication for treatment procedures. The country of origin for each product depends on the manufacturer/supplier and this information is available on the technical sheet of the product or upon request. Gentaur takes responsibility to fully disclose all information available regarding the origin of the product if requested.

Gentaur does not relabel the products. All products are delivered to the end user in their original packages, unsealed and with the labels placed by the manufacturer.

 

Process Control

Procedures

Documentation exists for providing the appropriate products and services as requested by our customers. If any changes are applied to the advertised products and services, and these changes are not yet reflected on our websites, our representatives are responsible for informing the interested customer in a proper manner prior to accepting an order for the products that were a subject to change of any kind. Document(s) will reflect the change once it has been appropriately verified and approved. These changes are controlled through our formal change procedure.

Equipment

Equipment critical to the proper storage of the products at our warehouse is constantly monitored and maintained. Similar procedures are applied for the equipment which maintains our accountancy program, CRM system, website network and ours means of communication with customers and manufacturers/suppliers. Documented procedures exist for equipment operation and maintenance. Equipment records are maintained and available.

Quality Records

Quality records are maintained and available including: customer orders, shipping records, inquiries/complaints, product information, packaging, training, and equipment. A product and batch numbering system is employed to allow for traceability throughout the entire process.

Non-conformance

When a product is determined to be non-conforming by the end user and an official customer complaint is filed, we require the entire step by step protocol/procedure which was applied when working with the product. After reviewing the provided information and a consultation with the technical department of the manufacturer of the product an official statement is issued. Should the problem with the performance of the product be due to a faulty batch or due to improper storage/transportation by Gentaur the customer is given a refund, a free replacement or store credit. Procedures exist to describe this process and further handling of each case.

Acceptance Activities

Upon receipt inspections on the product integrity are completed before products are released for sale. All documentation is reviewed and products are physically inspected. Evidence of inspections are supported by completed documentation.

Product Storage, Handling, and Distribution

Our goal is to minimize damage or deterioration of products throughout the process of transportation from the manufacturing facility to customer delivery. Storage, shipping and handling conditions recommended by the manufacturer are followed strictly and measures are taken for providing uninterrupted optimal conditions for each product during transportation and storage.

Storage areas are constantly monitored to protect product integrity in case of malfunction. Products are

properly identified with name, part number, lot number, expiration date, storage temperature, and acceptance status before they are placed in storage areas.

Materials are handled in a manner to ensure first in-first out use when required and expiration dates are monitored to ensure outdated products are removed from stock for appropriate disposal or retesting. Products are packaged and labeled for distribution in a manner that will enssure their physical and functional integrity during transportation. The mode of transportation is chosen to protect the quality of the product.

 

Specification Control

Incoming Materials

For most materials from our suppliers, certificates of analysis are received and reviewed. In addition, if warranted, incoming materials may also pass through a quality testing and review process. These materials will be maintained in a "Quarantined" status until the review, testing, and approval is complete.

 

Product / Batch Documentation

Product Specifications & Certificate of Analysis

Providing the product specification sheets, working manuals and certificates of analysis is an obligation of our suppliers. The majority of the products that we distribute have established product specifications. Specification information may be found on the Certificate of Analysis or Product Specification Sheet.

Certificates of Analysis are included in product shipments or can be requested from our Customer Service team.

Certificate of Origin

Information regarding the origin of the products may be provided on a Certificate of Origin or via an official statement by the manufacturer/supplier. Certificates of Origin can be obtained by request to our Customer Service team.

Container Label

Product information provided on the container label typically includes:

  • Product name and number
  • Lot number
  • Expiration date
  • Storage and handling information
  • Usage claim

We do not change in any way the labels on the containers and deliver them to the customers in their authentic appearance.

 

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