Intertek ASG Laboratory, Manchester, UK

Pharmacopeial Testing to GMP:

Specialist Testing of Raw Materials and Ingredients for GMP Manufacture

GMP testing is required on raw materials for manufacture of registered intermediates and API's, and other ingredients of drug products. For many chemicals, pharmacopeial tests are available to provide the basis for a specification. In other cases, customers may have their own in-house methods. Intertek ASG has the broad base of analytical technology and chemical analysis experience to provide a "one stop shop" covering most testing requirements from a single location.

The technologies available within Intertek ASG are extensive and are available to cGMP. Staff have broad experience of working with basic chemicals, intermediates, API's, excipients and other ingredients of drug products. Tests have been carried out to US, European and Japanese Pharmacopeia requirements.

Relevant tests include:

AAS
DSC
Elemental analysis
GC
HPLC
IR vibrational spectroscopy
Karl Fisher
Melting point
Polarimetry
TLC
UV Vis spectroscopy
Wet chemistry, titrimetry

Intertek ASG can also give technical advice on the most cost effective approaches to raw material testing for cGMP manufacture. In the event that existing Pharmacopeial methods are not appropriate, staff can advise on method transfer of existing in-house methodologies or method development and validation to cGMP where new methods are required.