Pharmaceutical industry

Pharmaceutical industry

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.

  • Clarity and degree of opalescence of liquids
  • Degree of coloration of liquids
  • Potentiometric determination of pH
  • Relationship between reaction of solution, approximate pH and colour of certain indicators
  • Relative density
  • Refractive index
  • Optical rotation
  • Viscosity-rotating viscosity meter method
  • Distillation range
  • Boiling point
  • Melting point – capillary method
  • Freezing point
  • Potentiometric titration
  • Absorption spectrophotometry, infrared
  • Absorption spectrophotometry, ultraviolet and visible
  • Thin-layer chromatography
  • Gas chromatography GD – FID
  • Gas chromatography Headspace – FID
  • Liquid chromatography
    • HPLC – UV/VIS
    • HPLC – UV/VIS (DAD)
    • HPLC – RI
    • HPLC – fluorescence
  • Loss on drying
  • Conductivity
  • Identification
  • Identification reactions of ions and functional groups
  • Identification of fatty oils by thin-layer chromatography
  • Odour
  • Limit tests
    • Ammonium
    • Arsenic
    • Calcium
    • Chlorides
    • Magnesium
    • Magnesium and alkaline-earth metals
    • Heavy metals
    • Iron
    • Phosphates
    • Potassium
    • Sulphates
    • Sulphated ash
    • Nickel in polyols
  • Total ash
  • Aluminium
  • Free formaldehyde
  • Composition of fatty acids by gas chromatography
  • Assay
  • Acid value
  • Ester value
  • Hydroxyl value
  • Iodine value
  • Peroxide value
  • Saponification value
  • Unsaponifiable matter
  • Determination of primary aromatic amino-nitrogen
  • Complexometric titrations
  • Water: semi-micro determination
  • Water micro determination
  • Ethanol content and alcoholimetric tables
  • Clarity and degree of opalescence of liquids
  • Degree of coloration of liquids
  • Potentiometric determination of pH
  • Relationship between reaction of solution, approximate pH and colour of certain indicators
  • Relative density
  • Refractive index
  • Optical rotation
  • Viscosity-rotating viscosity meter method
  • Distillation range
  • Boiling point
  • Melting point – capillary method
  • Freezing point
  • Potentiometric titration
  • Absorption spectrophotometry, infrared
  • Absorption spectrophotometry, ultraviolet and visible
  • Thin-layer chromatography
  • Gas chromatography GD – FID
  • Gas chromatography Headspace – FID
  • Liquid chromatography
    • HPLC – UV/VIS
    • HPLC – UV/VIS (DAD)
    • HPLC – RI
    • HPLC – fluorescence
  • Loss on drying
  • Conductivity
  • Identification
  • Identification reactions of ions and functional groups
  • Identification of fatty oils by thin-layer chromatography
  • Odour
  • Limit tests
    • Ammonium
    • Arsenic
    • Calcium
    • Chlorides
    • Magnesium
    • Magnesium and alkaline-earth metals
    • Heavy metals
    • Iron
    • Phosphates
    • Potassium
    • Sulphates
    • Sulphated ash
    • Nickel in polyols
  • Total ash
  • Aluminium
  • Free formaldehyde
  • Composition of fatty acids by gas chromatography
  • Assay
  • Acid value
  • Ester value
  • Hydroxyl value
  • Iodine value
  • Peroxide value
  • Saponification value
  • Unsaponifiable matter
  • Determination of primary aromatic amino-nitrogen
  • Complexometric titrations
  • Water: semi-micro determination
  • Water micro determination
  • Ethanol content and alcoholimetric tables

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.

  • Disintegration of tablets and capsules
  • Dissolution test for solid dosage forms
  • Uniformity of mass of single-dose preparations
  • Uniformity of content of single-dose preparations
  • Friability of uncoated tablets
  • Resistance to crushing of tablets
  • Uniformity of dosage units

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.

  • Microbiological examination of non-sterile products: microbial enumeration tests: TAMC &TYMC
    • Plate count
    • Membrane filtration
    • Growth promotion test
    • Suitability of the counting method
  • Microbiological examination of non-sterile products: test for specified micro-organisms
    • Bile-tolerant gram-negative bacteria
    • Quantitative test for enterobacteriaceae
    • Staphylococcus aureus
    • Pseudomonas aeruginosa
    • Escherichia coli
    • Salmonella species
    • Candida albicans
    • Clostridia  species

    Including growth promotion and system suitability testing

  • Microbiological assay of antibiotics
  • Efficacy of preservation
  • In-use microbiological 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:

  • 5°C
  • 25°C60%RH
  • 30°C65%RH
  • 40°C75%RH

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:

  • Implementation service for new products, transfer
  • Method Adaptation
  • Method Validation
Herbal testing

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.

  • 10-deacetylbaccatine III in taxus species
  • 8-Prenylnaringenin (8-PN) in Humulus lupulus L.
  • aescine in Aesculus hippocastanum
  • anthraquinone glycoside in rheum root
  • chlorgenic acid in green tea
  • flavonoids in Ginkgo biloba
  • hesperidin
  • hypericine in Hypericum perforatum
  • isoflavones in Glycine max L. and other species
  • metasynephrine and parasynephrine in Citrus aurantium
  • proanthocyanidine in grape seed and other species
  • sennosides in Senna
  • terpenoids in Ginkgo biloba
  • digoxine and lanatoside in Digitalis lanatae leaves
  • hyperosides in Crataegus extract
  • absence of valepotriates in valeriane
  • Milk thistle dry extract (% silymarin)
  • Aloe dry extract (% hydroxyanthracene derivatives expressed as Barbaloin)
  • Licorice dry extract (% glycyrrhizic acid)
  • Cascara dry extract (% cascaroside A)
  • Ginseng (% Ginsengoside)
  • Curcuma dry extract (% curcumin)
  • Valeriaan (% sesquiterpenic acid)
  • Stevia (% steviol glycosides expressed as Rebaudioside A)
  • Hedera extract (% hederacoside C)
  • Balotte extract (% chlorogenic acid derivatives)
  • Red wine extract (% polyphenol)
  • Frangula bark extract (% glucofrangulins expressed as glucofrangulin A)
  • Cinchona bark (% Total alkaloids – % Quinine type alkaloids)
  • Neroli oil
  • Tea tree oil (=Melaleuca oil)
  • Anis oil
  • Cod liver oil (Vit A / Vit D / fatty acids)
  • Olive oil (sterolen/fatty acids)
  • Maize oil (sterolen)
  • Caraway oil
  • Citronella oil
  • Dwarf pine oil
  • Eucalyptus oil
  • Lavender oil
  • Peppermint oil
  • Spike Lavender oil
  • Thyme oil thymol type
  • Turpentine oil
  • Peppermint oil
  • Garlic oil
  •  
  • Omega 3: DHA – EPA – total glycerides
  • Almond oil
  • Composition of fatty acids by gaschromatography for compendial substances
  • Cod liver oil
  • Olive oil
  •  
Cosmetic industry

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.

  • Plate count
  • Membrane filtration
  • Suitability of the counting method
  • Bile-tolerant gram-negative bacteria
  • Quantitative test for enterobacteriaceae
  • Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Escherichia coli
  • Salmonella species
  • Candida albicans
  • Clostridia  species
  •  

System suitability testing is possible

60 minutes consultation

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Take the test at the end

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The pharmaceutical concept of quality

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.

Our therapy process

Schedule Appointment

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Evaluation Session

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Final Test & Review

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