GMP Pharmaceutical Batch Release Testing

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 a contract analytical services partner with a strong history of delivering regulatory compliant API, IMP or finished products batch release testing to a consistently high standard with responsive turnaround times.

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 BP, EP, JP or USP). A range of technologies provide comprehensive release tresting resource for all types of pharmaceutical products including chromatography, mass spectrometry, spectroscopy and biophysical.

 

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 or inhaled drug products, oligonucleotides and biologics (such as monoclonal antibodies, biosimilars, bispecific antibodies and viral vectors). 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 GMP batch release testing contract services, our highly skilled scientists 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.