cGMP Quality Control Laboratory Analysis
Good Manufacturing Practice (cGMP) Quality Control (QC) testing for excipients, intermediates, raw materials, Active Pharmaceutical Ingredients (APIs) and cGMP batch release testing for drug products supporting pharmaceutical development and manufacturing.
Intertek provides GMP quality control analysis and offers technical advice on the most cost effective approaches to QC testing for GMP manufacture of pharmaceuticals, biopharmaceuticals and specialist healthcare products. Quality control analysis and GMP batch release testing is a routine activity in our network of GMP analytical laboratories which have experience for both small molecule and macromolecule drug products.
Intertek provides a full range of pharmacopoeial testing. If existing pharmacopoeial (compendial) methods are not appropriate, Intertek can provide method transfer for our client's methods covering a wide analytical technology scope from High Performance Liquid Chromatography (HPLC), Gas Chromatography - Mass Spectrometry (GC-MS), Nuclear Magnetic Resonance Spectroscopy (NMR), Infra-Red Spectroscopy (FTIR), Powder X-Ray Diffraction (XRD), Inductively Coupled Plasma -Mass Spectrometry (ICP-MS) and more. If new methodology is required, Intertek can undertake method development and validation in accordance with the ICH Guidance. Expertise includes solids, semi-solids, lyophilized powders, liquids, parenterals, Metered Dose Inhalers (MDIs) and medical devices. Intertek routinely carry out method remediation for our clients methods.
- Excipients and Raw Materials Analysis:
- Compendial analysis covering a range of pharmacopeia methods (USP, EP and JP)
- Client specific method
- Pharmaceutical Analytical Research and Development
- Proteins and Biotechnology Product Batch Release Testing
- Intermediates & Finished Product Testing:
- Organic Volatile Impurity & Residual Solvent Analysis
- GMP batch Release Testing covering a wide range of technology
- Degradation Studies and Pharmaceutical Impurity Identification
- ICH Stability Testing & Storage
- Physical Characterisation
Related cGMP Services:
- cGMP Pharmaceutical Testing
- GMP Laboratories
- Biologics and Biosimilar Product Release Testing
- Physical Characterization Testing for Pharmaceuticals
- GLP / GMP X-Ray Powder Diffraction
Other QC Services:
Request more information to see how Intertek can help your organization with cGMP Quality Control Laboratory Analysis.