Raw material testing is essential if you wish to manufacture good quality, effective and safe pharmaceuticals. Properties of raw materials like particle size or the fact that there is polymorphisms can influence how the raw materials need to be blended. Therefore it is important to establish the identity, purity and quality of the raw material for its intended use before manufacturing begins.
Need for testing
Pharmaceutical industry uses the services of recognised chemical testing laboratories because hundreds of raw materials and ingredients are used to formulate the pharmaceuticals. It will not be possible to manufacture quality pharmaceutical products unless all the raw materials have undergone testing before they are used in the manufacture of pharmaceutical products. Poor quality raw materials could result in poor quality of the finished product and could even be subject to product recall. A recalled product causes loss of reputation and the material costs could be equally damaging.
Raw material testing for pharmaceuticals is carried out on all incoming raw materials to verify that they have been correctly supplied as per requirements and specifications. This is an essential step to ensure safety and quality in the finished product. Any supply of incorrect raw material can compromise the quality and safety of the finished product. It could even lead to manufacturing delays, heighten costs and waste time. Without testing raw materials for their quality and suitability the pharmaceutical product, if formulated with low quality and unsuitable raw materials, would result in finished product failure. Testing labs can help pharmaceutical companies establish specifications for the raw material during the development of the product itself.
Testing lab recognition
Testing laboratories for pharmaceuticals are approved by the State Food and Drug Administration (FDA) and also by the Central Drugs Standards Control Organisation. These testing laboratories can carry out chemical testing, physical characterization, and microbiological analysis of the raw materials as per pharmacopoeia requirements and other safety specifications. These independent chemical testing labs also offer comprehensive raw material testing needed by the pharmaceutical industry as required by the regulatory authorities. Also the pharmaceutical industry would like raw material testing to be swift and provide accurate analysis. Chemical testing laboratories have been traditionally analysing raw materials for their quality and suitability for use in formulations.
Accuracy in testing
While a number of pharmaceuticals have in-house laboratories yet they use the services of independent recognised testing labs because they have to ensure that all incoming raw materials have been tested 100 percent. Moreover, recognised chemical testing labs are better equipped to handle all the complex and lengthy analytical methods involved in raw material testing. The raw material testing needs to be accurate because without the raw materials being analysed as qualitative and suitable it cannot be released. Even after the release, regular raw material testing is required to ensure that the suppliers provide raw materials that are consistent with the specifications in each lot they supply.In this way raw material testing also serves to qualify suppliers of raw materials.