QUALITY ASSURANCE

The care we give to our system of quality assurance comes from our wish for transparency with our customers and the need for clear transparency of our results. The Quality Assurance department (QA) of LUNARIA makes sure that all our internal targets with regard to quality are formulated and implemented. The main responsibility of the QA department is to ensure continuously high quality of our activities. All areas of our work are aimed at achieving a high level of quality: the correctness of the results is our key target. LUNARIA has service contracts with all suppliers of laboratory equipment.

Quality Assurance Responsibility

The Quality Assurance (QA) department of LUNARIA makes sure that all our internal targets with regard to quality are formulated and implemented.

The main responsibility of the QA department is to ensure continuously high quality of our activities. All areas of our work are aimed at achieving a high level of quality: the correctness of the results is our key target.

Regular training of the Quality Control staff with emphasis on the improvement of their skills and qualifications is a commonplace in our company.

Our laboratories are equipped with instruments that meet high qualification requirements, for example Agilent and Waters high performance liquid chromatographs (HPLCs), LC-MS, gas chromatography (GC), UV-spectro-photometers, stability chambers, Sotax dissolution testing equipment, etc.

The equipment is subjected to periodical service maintenance, validation and calibration, where applicable, and it is renewed and supplemented on regular basis.

Our method transfer system guarantees the high quality of our data interpretation and reporting.

The Aim of our QA

  • to focus on maintaining the documentation based on an SOP (Standard Operating Procedure) and SAM (Standard Analytical Method)
  • to provide ongoing supervision of the calibration and the qualifications of our equipment
  • responsibility for the internal inspections and inspections by state authorities (SÚKL, ÚSKVBL)
  • to supervise reagents and reference standards in our laboratories
  • to ensure training and development programme, to record all internal and external training of  employees
  • to ensure the validations and transfer of manufacturing processes according to GMP requirements. Procedures describing the analytical methods required for testing are either, procedures developed and documented during the analytical development we perform, or validated procedures taken from other laboratories after transfer.

Our method transfer system guarantees the high quality of our data interpretation and reporting.

Certificates

Lunaria Holds The Following Certificates:

Certificate of GMP Compliance Of a Manufacturer

Quality control testing of Human Medicinal Products and quality control testing of imported medicinal products.

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Certificate of GMP Compliance Of a Manufacturer

Quality control testing of Human Investigational Medicinal Products and quality control testing of imported medicinal products.

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Certificate of GMP Compliance Of a Control Laboratory (Vet)

Quality control testing of Veterinary medicinal products

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Manufacturing Licence

Microbiological quality control testing

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Registration and Documentation

The requirements from national organizations, as well as customer’s policies, continuously evolves, having a strong influence on the approval process for introducing a new drug onto the market.

These activities are carried out in close cooperation with the Quality Assurance department. We study the basic documents, such as ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and FDA (Food and Drug Administration) guidelines, publications from the WHO, special requirements from our customers, new law, and many others. We check the quality of the documents issued by LUNARIA (to customers, to institutions and to organizations) in order to be sure that the results are presented in the required form. We also support quality assurance in the change and revision of documents and equipment.