Reasons for Laboratory Testing of Raw Materials for Pharmaceuticals

Reasons for Laboratory Testing of Raw Materials for Pharmaceuticals

Reasons for Laboratory Testing of Raw Materials for Pharmaceuticals

Raw materials for pharmaceuticals are tested in recognised testing laboratories because it is important to control quality of the raw materials. NABL certified testing labs have the equipment as well as experienced scientists who are specialised in testing and analysis. Pharmaceutical companies get those raw materials tested, which are going to be used in production, as well as the raw materials that are being supplied to them by vendors.

Quality control

Controlling the quality of the raw materials,like excipients and other substancesused in the product is a must. Raw material testing in labs ensure the quality of raw materials is as suitable as the active pharmaceutical ingredients (APIs), so the finished product is effective for the purpose it has been made. The pharmaceutical industry uses a very large variety of raw materials and literally hundreds of ingredients can go into the manufacturing of a single product. Pharmaceutical manufacturers get their raw materials tested from independent testing laboratories to verify the purity of raw materials and that they are contaminant free as contaminants can cause product failure.Since pharmaceutical testing labs provide Certificate of Analysis, pharmaceutical manufacturers as well as suppliers get raw materials tested on a regular basis as a proof or quality.

Safety and suitability

Testing laboratories provide the information on the safety of the raw material selected for a product and also the suitability of the many substances used in any one product. Labs test raw materials for toxicological concerns, pharmaceutical response and compatibility of the excipients to produce the desired hardness or dissolution rate. These are all important aspects for pharmaceutical drug development.Most pharmaceutical companies, therefore, get their raw materials tested in recognised testing labs that understand pharmaceutical and regulatory requirements.

Scientific evaluation

Pharmaceutical testing laboratories have the scientists as well as advanced instrumentation and technical experience to solve a problem if it does arise. Pharmaceutical testing labs have the capability to carry out chemical testing, physical characterization, and microbiological analysis as per pharmacopeial requirements. Testing raw materials ensures that the right materials have been selected for formulating a particular pharmaceutical drug. Sometimes a particular raw material might not be available in large quantities for drug production; a testing lab can determine a substitute material that can qualify to take its place.In simple terms a pharmaceutical raw material testing laboratory carries out testing so the quality, safety and efficacy of raw materials can be scientifically evaluated.

Reputation building

Product failures and defects in products can lead to loss of revenue for a company.

All the various raw material testing processes are therefore carried out with care so as to prevent product failure and recall. Product recall can give the pharmaceutical company a bad name but raw materials testing from a reputed testing labcan help to build the reputation of the pharmaceutical manufacturers as a company that provides excellent products.Laboratory testing of raw materials is therefore required to prevent product failure, consistency in finished product and consumer safety.

George Abbot

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