cGMP Quality Control Testing
GMP Quality Control (QC) Testing for Raw Materials, Active Pharmaceutical Ingredients (API), Intermediates to International Pharmacopoeial Specifications
Quality control testing of raw materials is needed from early stage product development through to commercial batch release. The quality of raw materials can vary considerably from supplier to supplier, and even batch to batch and so controlling the quality of the input material is key to the success of the product.
Often the raw materials and excipients used in early product development are not GMP compliant, with the assumption that they will be substituted for GMP grade material as manufacturing is scaled-up and the product moves to clinical supply. As a result raw materials are perhaps not given much attention until later in development when the implications of criteria such as impurity content are costly and could cause the final product to fail to meet specification as a worst case.
With your focus on your core business activities, you will need to select a partner with a strong history of delivering to a consistently high standard when you outsource quality control testing.
Testing of pharmaceutical raw materials to international pharmacopoeia specifications has become a specialty of Intertek. With our knowledge of analytical chemistry and our vast range of instrumental techniques, we can undertake the vast majority of the chemical tests listed within the international pharmacopoeias.
In addition to routine QC batch release, as experienced analytical chemists, we are used to trouble shooting quality control issues and can assist you by developing a detailed specification for the material. Method development and validation services compliment pharmacopoeial testing services should specialist QC methods be required.
With our global network of GMP compliant analytical laboratories
in North America and Europe, our highly skilled scientists routinely conduct QC testing for raw materials, excipients, in-process samples and finished product batches. We tailor our QC programs to your requirements and through our wide range of GMP qualified analytical instrumentation we can provide services for the most basic of tests through to more specialised techniques, and so obtain the data you need, at the right time, to make critical quality control decisions about your product.
With a flexible model for providing your QC support, Intertek’s scientists provide on-going QC programs or extra capacity for you during times of heavy workload. No matter what raw material you need tested we will always be focused on getting accurate results within your timelines to help you make informed decisions.