Pharmaceutical

The pharmaceutical industry is the part of the healthcare sector that deals with prescription and Over the Counter (OTC) medications. The industry comprises different subfields pertaining to the discovery, development, production, and marketing of medications. These more or less interdependent subfields consist of ethical drug manufacturers, marketers, and biotechnology companies.

The main goal of the pharmaceutical industry is to provide consumers with ethical drugs that prevent infections, maintain health, and cure diseases. This industry directly affects the global population, so a number of international regulatory bodies monitor things like drug safety, patents, quality, and pricing. Here are some of those regulatory entities:

  • US Food and Drug Administration (or FDA)
  • World Health Organization (or WHO)
  • Medicines and Healthcare Products Regulatory Agency (or MHRA)

The pharmaceutical industry is evolving and has made a great deal of progress over the last decade due to a research-oriented approach that has improved technologies, developed infrastructures, and increased research in the field of bioscience. 

Because pharmaceuticals directly affect millions of people’s health, industry manufacturers are very strict about ensuring the safety and quality of drugs at each level of the supply chain. These companies use fixed, regulator-certified suppliers of raw materials. Companies also store the raw and packaging materials in separate warehouses.

After a company processes the raw materials, it makes the final drug at the manufacturing unit.   

During the synthesis of some pharmaceuticals it is sometimes necessary to use solvents in order to increase the yield or purity of the product.  After the pharmaceutical is produced, the solvent(s) are removed to the greatest extent possible.  The products are then tested for any residual solvents in order to limit patient exposure.  Residual solvents are separated into classes according to the risk to patient health. Data supports that the EST FLEX syringe-based headspace sampling system to be an exceptional platform for performing USP<467> sample introduction.  Class 1 solvents are to be avoided at all costs as they are known to be human carcinogens or have adverse effects on the environment.  Class 2 solvents have less severe toxicities but should be avoided because of the potential of adverse effects.  Finally, Class 3 solvents have low toxicity and can be used when needed as long as they are below established limits.  Pharmaceutical manufacturers are required to test for residual solvents in order to ensure that any residual solvents in the product are below established exposure limits.  United States Pharmacopeia (USP) general chapter 467 describes a static headspace gas chromatography procedure for the determination of residual solvents

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