Quality Control Services

Quercus offers analytical services for testing of pharmaceutical raw materials, excipients and release testing of finished products.

Chemical analysis

Our QC Laboratory is able to support your analytical needs from pharmacopoeial analysis of raw materials to finished products. Quercus Labo can take over full analysis so that our customers can stay focused, even when they have limited internal capacity. QUERCUS Labo is equipped for the testing of a wide range of pharmaceutical forms (solid dosage forms, solutions, creams, oral sustained release forms, etc)

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ICH Q3 Elemental Impurities (ICP MS)

ICH Q3 described the expectations with respect to controlling elemental impurities in drug products or their excipients. Authorities have increasingly been focussing on elemental impurities lately. Quercus, therefore, invested in a new Inductively coupled plasma mass spectrometry (ICP-MS) in order to support QC analysis on elemental impurities and heavy metals with a unique sensitivity, accuracy, and precision.

Our QC team can help to support audit readiness in this matter for our customers!

Method development and validation

We develop scientifically sound and cost-effective analytical methods in co-operation with our customers. Services facilitating liable QC testing provided to our customers:

  • Development and implementation service for new products,
  • Transfer of existing methods
  • Method Adaptation and Optimization
  • Method Validation

Cleaning validation

Quercus is able to develop and validate analytical methods in the PPM range to support your cleaning validation. If needed, we can come on-site to assist you in taking swabs for cleaning validation. Both chemical and microbiological swabs can be taken to assist your cleaning validation activities.

Micro Lab

QUERCUS Labo tests the microbial quality of raw materials, cosmetics and pharmaceutical finished products:

  • Microbial count (TAMC & TYMC)
  • Exclusion of specified pathogens,
  • Efficacy of microbial preservation (PET).
  • Microbiological assay of antibiotics
  • Bacterial endotoxine test (LAL test)

Next to product testing we are able to support our customers with the analysis of their purified water according to Ph. Eur.

If needed we can assist you in keeping your clean rooms qualified. We have active air sampling equipment and Qualified Quercus staff can go to our customers to take samples. If guidance is needed for best practice on air sampling, monitoring of compressed gasses etc… we are there to help our customers.

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Environmental monitoring

Quercus Lab invested in state-of-the-art equipment to perform active air sampling as well as a sampling of compressed gasses (air, nitrogen, argon, etc) for microbiological assessment.

QC operators of Quercus Lab can come to the customer facility to take samples in a controlled way!

Stability testing

Investigating the stability and shelf-life of a finished product is an important area of expertise at QUERCUS Labo. We can assist you in defining the best approach for the study of the stability of your product, including accelerated testing, in-use or ongoing stability testing.

Storage conditions in accordance with ICH guidance:

  • 5°C
  • 25°C / 60%RH
  • 30°C/ 65%RH
  • 40°C/ 75%RH

All testing is performed in our laboratory under the supervision of an independent study coordinator who manages your project. 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.

EU Import & QP batch release services

The analytical laboratory of Quercus Labo has authorization 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.

Also, companies 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.

Contact us

If you have any questions or need additional information on our services, please feel free to contact us.