Validation in the Pharmaceutical industry

The world of pharmaceuticals is crucial to the medical field and to the human race’s overall well being.  As such an important piece, the quality of these pharmaceuticals is integral to a successful product and eventually a cured customer.  Being coined “Beantown” long ago, we now hear stirrings of another nickname for Boston, “Genetown”.  As a hotbed for biological and genetic companies as well as high powered minds in the community, pharmaceutical companies fit right into this science driven city.  With all of this work being done there must be practices in place to ensure that this work is reflected in today’s society, and one major part of this lies with the pharmaceutical industry.  These practices are outlined by cMGP or the Current Good Manufacturing Practice, and they provide specific details regarding contamination, the lifecycle of the product, the necessary documentation of the steps and procedures involved.  in order to create valid products, certain criteria must be considered.  Some of which include the quality of the equipment being used, the quality of the employees working in the factories, the quality of the vendors chosen to send the product to, and of course testing of the produced drug.  Within the company there is undoubtedly quality control practices in place to ensure the plants are run correctly and efficient.  Within the plants there are also quality control practices going on that require the inspection of packages being sold.  By doing these things they can optimize their processes, narrowing defects and bad batches, lowering the cost of production.  This all comes in Phases in which they link the research and development (Phase 1) to the correct processes that must be put in place to generate a reliable product (Phase 2) and a maintenance validation phase that is the revisiting of documentation throughout the company as well as an audits of the company.