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Pharmaceuticals provide active ingredients, some of which are hazardous, and also binders which are used to allow the active ingredients to work properly for specific diseases. This category includes diagnostic agents, prescription drugs, vaccines, vitamins, and over-the-counter medicines for both human and veterinary use. It is important in the design and operation of the facility to ensure the quality of the product while protecting the workers from potential health effects.

The United States pharmaceutical industry is one of the most highly regulated in the world. The Food and Drug Administration (FDA) enforces stringent government mandates and inspects all facilities on a periodic basis. They make determinations of the efficacy of drugs and the unwanted dangers involved in taking them. System failure at pharmaceutical production facilities must be dealt with in order to avoid serious consequences from the production and use of drugs. Many times there is an incomplete set of data presented due to isolation of parts of the process, redundancy, and confusion due to different reports with different conclusions, missing data, and no centralized control, and complaints assume a low priority at the company.

Best Practices in Control of Production and Use of Pharmaceuticals

  • • Conduct a risk assessment of all products or materials being handled by the workers and include toxicological data and permissible levels of exposure by quantity of the material, time exposed, and frequency.
  • • Establish an operational risk-based system at the manufacturer to identify hazards, prioritize seriousness, record accurately all data, determine the causes of the hazard, isolate the problem, and take immediate corrective action. The FDA has to approve all actions taken to eliminate the risk.
  • • Corporations should establish as a priority, policies and procedures supporting a risk management system with leadership at the top of the company evaluating and enforcing all necessary actions. Always use industry standard procedures and those approved by the FDA.
  • • There must be complete transparency in everything done to avoid hazards. This allows the regulators to thoroughly understand the conditions occurring and give appropriate advice on corrective actions. Regulators by law must protect business secrets involving processes and products.
  • • Utilize clean rooms with air locks and with controlled air volume, air cleanliness, and controlled temperature and humidity to help prevent contamination or cross-contamination of the pharmaceuticals which could either reduce the effectiveness of the medication or cause it to become toxic to the individual. The workers should also be wearing special apparel to protect the product as well as to protect themselves from the product.
  • • For extremely hazardous pharmaceuticals, all preparation work should take place in special biosafety cabinets and if necessary use an isolation system of glove boxes to protect the worker.
  • • All employees must utilize some form of self-contained breathing device for self-protection when working with pharmaceuticals during production. The type of device used depends on the chemicals involved.
  • • Never allow the final product or raw materials to escape to the atmosphere or to be dumped down the drain to go to a body of water.
  • • There should be very limited access to all pharmaceutical production facilities.
  • • Pharmaceutical production facilities should be extremely well sealed and kept under negative pressure to prevent air leakage carrying dangerous substances to the public.
  • • Air-handling systems should not vent directly to the outside air until they pass through properly operating HEPA filters. Air pressure alarm systems should be utilized and immediately responded to when there is an unwanted change in air pressure in the system.
  • • All employees leaving the work area must go through showers and change of clothing before going to other parts of the facility or going home.
  • • When changing filters for the ventilation system, ensure that the area is enclosed and dust cannot get on the worker or be inhaled. Check all filters on a regular basis to make sure they are functioning correctly and not getting too dirty before replacing.
  • • When using portable vacuum cleaners or dust collectors, make sure that an appropriate HEPA filter is being used and then when cleaning the equipment, do it in the area under negative pressure.
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