GMP Batch Release Testing
Good Manufacturing Practice (GMP) pharmaceutical batch release testing or lot release testing to help you to ensure the quality of your drug products including specialised testing for inhalation products or biologic therapeutics
Good Manufacturing Practice (GMP) batch release testing is a necessary requirement to ensure high quality pharmaceuticals and biopharmaceuticals prior to release for sale, supply or export. Whilst you focus on your core business activities, you will need to select a contract analytical services partner with a strong history of delivering regulatory compliant batch release testing to a consistently high standard.
Our GMP batch or lot release testing teams apply a wide range of analytical technologies to provide responsive release analytics to ensure that healthcare products meet the product specification within the Marketing Authorisation (MA) or Clinical Trial Dossier (CTD). Intertek's batch release testing expertise includes chemical, physical and biological testing (including pharmacopeia analysis methods such as EP, JP or USP).
We provide batch and lot release testing for active pharmaceutical ingredients (APIs), investigational medicinal products (IMPs) and finished products with Marketing Authorisation across a wide range of pharmaceutical products including specialist expertise for inhalation products or biologic therapeutics. Our clinical trial supply manufacturing services provide Qualified Person (QP) release in addition to GMP batch release testing according to the EU Directive and Medicines for Human Use (Clinical Trial) Regulations.
With a long history of providing batch release testing contract services, our highly skilled scientists routinely conduct testing programs for clients around the world from our global network of GMP compliant analytical laboratories in North America and Europe. We tailor our release testing programs to your requirements and can provide services for the most basic of tests through to more specialised techniques. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
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