Method Development & Validation
Method Development & Validation Looking for method development and validation support in compliance with GMP and ICH Q2? Quercus Laboratory has the necessary QC equipment and expertise to support you in your validation challenges. Please do not hesitate to contact us for more information on our method development and validation services. Read more Well-defined methods […]
QC Chemical Analysis
QC Chemical Analysis Looking for QC services to complement your laboratory? Our GMP-certified QC laboratory can support your analytical needs from pharmacopoeial analysis of raw materials, APIs, and IMPs to finished medicinal products. Please do not hesitate to contact us for more information on our QC chemical analysis services. Read more Full analysis? We’ll take […]
The importance of high-quality gas distribution networks for critical process gases, even in the early development phase
The quality of process gases and gas distribution networks is becoming increasingly important for biotech pharmaceutical processes and ATMP sites. In this blog, we highlight the importance of a qualified process gas and distribution network, even at an early stage of development.
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New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?
On August 21, 2022, the new GMP Annex 21 will enter into force. This Annex contains the GMP requirements for MIA holders when importing medicinal products from outside the EU/EEA. Learn more here.
Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring
Compressed air and other proces gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in direct contact with products to clean, aerate, or move them through the processes or the using process gases in fluid pumps that take products through the production and filling processes. Compressed gases, such as nitrogen or argon, can also be used for blanketing or to spray or coat a product. The risks associated with the use of these gases, depend on the amount and type of product contact and based on this risk assessment, a suitable monitoring plan should be in place.
Elemental Impurities ICH Guidelines: Roadmap to Compliance for Your Drug Products
ICH Q3D has been adopted worldwide since 2018 and applies now for all existing and new drug products. Existing wet chemical and colorimetric heavy metal quantification tests, such as Ph. Eur. Heavy metals chapter 2.4.8 and USP<231>, have been replaced with methods that use modern instruments to quantify specific elements in drug products and ingredients. While the existing wet chemistry methods have been in effect for nearly 100 years, they are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients.
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Contact us Let’s talk Do you have questions about industry guidance? Are you looking for help in developing a testing plan or regulatory submission? Do you have a product ready for testing, and need a quote? T. +32 (0)15 70 91 28 F. + 32(0)15 70 91 22 Wijmenstraat 21P, B-9030 Mariakerke, Belgium Follow us on […]