Intertek ASG Laboratory, Manchester, UK

Pharmacopoeial 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, pharmacopoeial 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 Pharmacopoeia requirements.

Relevant tests include:

asg.nwtc@intertek.com

+44 (0) 161 721 5247

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• ASG Laboratory Techniques
• ASG Services A-Z

• Global Intertek Locations
• Global Laboratory Capabilities

• 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 Pharmacopoeial 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.

See also:

• Method Development and Validation