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The pharmaceutical concept of quality is driven by a holistic approach of safety and efficacy of the medicinal products made available to patients and their physician or therapist. Batch by batch quality control is mandatory to demonstrate that the medicinal product is compliant with the initial characteristics of the product. Each test should be carried out in accordance with regulatory requirements following the methods, described in the approved documentation, submitted to obtain a marketing authorization.
QUERCUS Labo provides pharmaceutical companies the testing approach – including on-going stability studies and adaptation of method with validation – to fulfil this obligation.
Outsourcing your routine testing to QUERCUS Labo is fully transparent to your production processes. From the reception of samples to the delivery of the final report, we assume full responsibility and carry out those responsibilities immediately.
QUERCUS Labo performs all testing on fully qualified equipment, and provides you with a certificate detailing the results as soon testing is finished and reviewed, according to sterict quality procedures. At Quercus Labo you receive high-quality reports as fast or faster than you obtain them from your own laboratory and with totally reliable quality assurance.
For a list of the compendial techniques and methods available at QUERCUS Labo, click here. For more information on the pharmacotechnical testing click here.
The analytical laboratory of Quercus labo has an authorisation for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC. If requested, our own qualified persons (QPs) can certify the batch release testing.
In accordance with Annex 16 of the EU GMP Guidelines, the client’s QP can refer to this laboratory certificate – reducing the workload that is involved in the batch release of a finished medicinal product.
Also companies from non-EU states that want to import medicinal products can rely on Quercus for EU product release. We take care of EU import release responsibilities for companies outside of the European Union. Upon request, we can monitor (contract) manufacturing and ensure that quality management according to Good Manufacturing Practice (GMP) requirements are met.
This QP certification is performed fully in line with reference to Annex 16 of EU GMP guidelines.
Tablets and capsules are the most frequent used pharmaceutical forms. QUERCUS Labo provides you with the pharmaceutical technical procedures needed for testing those forms with immediate release or extended release.
Uniformity of mass of delivered doses from multidose containers is available for granules, powders for oral use and liquids for oral use, which are supplied in multidose containers provided at manufacture with a measuring device.
For compounding pharmacists it is important to have information on bulk and tapped density, and also particle size distribution. Testing for bulk and tapped density and sieving tests are available at QUERCUS Labo.
Microbiological testing requires special equipment, experienced people, and specific quality procedures. Contamination of samples must be avoided. QUERCUS Labo provides you with all of this plus verified excellent quality for both routine testing and stability studies. All actions are meticulously recorded, quality control is maximised, and every precaution taken to ensure reliable results.
A most efficient organisation ensures that all tests are initiated immediately upon arrival of the samples at QUERCUS Labo with reporting sent out at the moment that test results are available.
QUERCUS labo test the microbial quality of raw materials and non-sterile pharmaceutical forms: microbial count, exclusion of specified germs with identification, efficacy of microbial preservation.
QUERCUS labo has also a broad experience in microbiological assay of antibiotics. However HPLC is the method of first choice for the assay of many antibiotics, some antibiotics still require a microbiological potency testing.
Including growth promotion and system suitability testing
Investigating the stability and shelf-life of a pharmaceutical product is an important area of expertise at QUERCUS Labo. All testing is performed in our laboratory under the supervision of an independent study co-ordinator who manages your project and is responsible for quality assurance and follow-up. Your study will be conducted according to the current quality standards and in full accordance with regulatory requirements. Moreover, if requested you will receive complete documentation of the stability. You can rely on our consultancy for regulatory support and assistance in the submission of applications.
Storage conditions in accordance with ICH guidance:
Methods are implemented in accordance with EU-GMP guidance on quality control and life cycle management. Services facilitating liable QC testing provided to our customers:
Herbals are globally accepted for use in medicines, health products, cosmetics and have also a function as starting material for the synthesis of active pharmaceutical ingredients (API’s). The aim of industry is to deliver to the patient or consumer safe and efficient products. Regulators request also state-to the art controlled quality.
QUERCUS Labo offers industry laboratory services for reliable analysis of herbals and products from herbal origin. In collaboration with the University of Antwerp, Department of Pharmaceutical Sciences, the following modern phyto-analytical methods are readily available.
Microbiological testing requires special equipment, experienced people, and specific quality procedures. Contamination of samples must be avoided. QUERCUS Labo provides you with all of this plus verified excellent quality for both routine testing and stability studies. All actions are meticulously recorded, quality control is maximised, and every precaution taken to ensure reliable results.
A most efficient organisation ensures that all tests are initiated immediately upon arrival of the samples at QUERCUS Labo with reporting sent out at the moment that test results are available.
System suitability testing is possible
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The pharmaceutical concept of quality is driven by a holistic approach of safety and efficacy of the medicinal products made available to patients and their physician or therapist. Batch by batch quality control is mandatory to demonstrate that the medicinal product is compliant with the initial characteristics of the product. Each test should be carried out in accordance with regulatory requirements following the methods, described in the approved documentation, submitted to obtain a marketing authorization.
QUERCUS Labo provides pharmaceutical companies the testing approach – including on-going stability studies and adaptation of method with validation – to fulfil this obligation.
Wijmenstraat 21P
9030 Mariakerke (Gent)
Belgium
VAT BE0457113884
