QACS LAB (QUALITY ASSURANCE & CONTROL SYSTEMS LTD)

Company Profile

The QACS laboratory was founded in 2002 by Dimitris Melissos and Charilaos Tsitouris, as “Quality Assurance & Control Systems” limited company, listed in the General Electronic Commercial Registry (G.E.MI.)  by the number 004763801000. The main activity of the laboratory is to provide to its customers in Greece and abroad a wide range of testing services, analytical and microbiological, in the area of cosmetics, pharmaceutical and medical devices. The QACS LAB offers contract, laboratory services related to QC and R&D of pharmaceutical proprietary medicines. Services of stability, storage, microbiological and analytical testing of active substances, excipients and end products. Key competences in Preservation Efficacy Testing (PET) also known as “Challenge Testing for Pharmaceuticals”, Stability Studies, Method Development, Method Validation.

The team involved in GMP related functions is called “QACS Pharma”. The laboratory is certified by the Greek National Organization for Medicines, EOF decision 26969 20/04/2016, manufacturing authorisation no. 0000008934/16/2, for developing and evaluating analytical control methods for the pharmaceutical products, determining their active substances and admixtures, conducting stability studies on pharmaceutical products according to the ICH instructions for releasing batches of end products. It is also certified for physicochemical controls in end products in the form of Creams for external use, Oral suspensions, Syrups, Suppositories, Eye drops (solution), Nasal solutions, Gels external, External use solutions (lacquers), Tablets, Capsules, Ointments, Pharmaceutical shampoos, Liquid injectables.

The QACS LAB also offers contract laboratory services to the cosmetics industry. Services include, EU compliance, Safety Assessment, Efficacy testing, in-use and in-vitro tests. Dermatological testing, Patch tests. A complete range of Microbiological and Physicochemical testing. Specialized in preservation efficacy offering a number of challenge test protocols (EP, USP, ISO 11930).  The quality system of the QACS lab is accredited under the EN ISO 17025, certified under ISO 9001, GMP and GLP.

On the Biocide sector, the QACS lab provides antibacterial efficacy tests (Suspension tests, Handrub tests). Recently accredited under the ISO 17025 for the test methods on disinfectants and antiseptics with the techniques referred in EN 14885: 2015. The QACS laboratory accreditation scope is therefore extended with quantitative suspension tests (phase 1 & phase 2, step 1) quantitative non-porous surface test  (phase 2, step 2) and Hygienic handwash and handrub tests (phase 2/step 2).

The QACS lab acquired GLP certification on the implementation of in vitro tests on skin and eye irritation. The testing principle consists of the application of the test substance in different conditions on reconstructed cells. The determination of cell viability is linked to the irritation potential of the substance tested. Reference: In Vitro EpiDerm™ Skin Irritation Test (EPI-200-SIT), In Vitro Eye Irritation Test, EpiOcular™ (OCL-200-EIT).

Target Partners & Collaborations

The cosmetics and human health sector constitutes a key part of QACS activities. QACS has achieved a strong position in the Greek, European and ME markets. Clients are distributed in Australia, Austria, Belgium, Bulgaria, Canada, China, Denmark, Egypt, Finland, France, Jordan, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Lebanon, Norway, Poland, Romania, Serbia, Spain, Sweden, The Netherlands, Turkey, USA. International clients represent the 60% of the health product testing business.

Founding member of the European Responsible Person Association (ERPA). ERPA is the European cosmetic Responsible Person Association gathering European Professional Responsible Persons, Safety Assessors and Cosmetic testing Laboratories. 

Founding members of the Hellenic Cosmetic Society (ΕΕΚ, 1996). A society of 300 members, were key QACS personnel is among the elected active board members for at least 5 years.

QACS is representing FERA UK (FAPAS) in Greece and Cyprus. FAPAS, a world renowned accredited proficiency testing provider, supporting the food and water testing industries since 1990.

Collaborations with testing laboratories and institutes

• ALS Global, ALS Czech Republic s.r.o,. Collaboration on the analytical testing of Pharmaceutical materials and finished products. Heavy metal testing using ICP-MS,
• MatTek, In Vitro Life Science Laboratory, in Bratislava Slovak Republic. Collaboration on the subject of in vitro tests on skin and eye irritation.

Participation as exhibitor in more than 20 international fairs, since 2008, namely In Cosmetics, Beauty Eurasia, CPHi, Beyond Beauty, PLMA.

Participation as trainers and speakers in several occasions. Seminars and conferences in Italy, Germany, France, Israel, Turkey.

Technologies / Services offered or sought

The development of analytical methods is a standard service of the QACS PHARMA laboratory. Examples of projects involving method development associated with method validation:

Technology and R&D

In collaboration with research laboratories of the University of Athens, the Agricultural University of Athens, research institutes and the industry. The subjects of interest are linked to food adulteration, the control and prevention of pathogens, the stability and shelf life of goods, the risks from the use of chemical substances and processes.