What to Know About Pharmaceutical Manufacturing and the Making of Medicine

The healthcare sector that produces medications is the pharmaceutical industry. The industry has many subfields comprising the larger processes of developing, producing and marketing medication. The overall goals are to provide drugs and treatments that improve and maintain good health, prevent infection and cure diseases. Drug manufacturers, biotechnology companies and drug marketers work together to advance the health of the global population, leading to international regulatory agencies and oversight to ensure quality, safety, pricing and patents. Any drug that intends to be manufactured, whether within the United States or across the globe, may be subject to involvement by the U.S. Food and Drug Administration, the World Health Organization, and Medicines and Healthcare Products Regulatory Agency.

The Production Processes

Over the last decade, new technology, more developed infrastructures and greater research into the field of bioscience have propelled the pharmaceutical industry forward. Production of new medicine or treatments has made significant advancements in stopping or curing major infections like HIV or cancer. The fragility of human life and the severe impact of a poor quality or toxic product make for a dangerous combination when producing drugs. There are very strict regulations over the amount of a substance used in a compound, where material can be sourced from and the sterility of the environment for processing. Accuracy of dosage starts with extremely precise measurements for drug compounds. To reduce the potential for human error, many of the production processes are automated, such as fluid bed drying, extrusion and capsule filling. These systems are continually monitored and checked for accuracy, consistency and quality in the final product.

The Supply Chain

As with any manufacturing center, quality assurance is of utmost importance. However, the involvement of regulatory agencies ensures that high standards and expectations are both set and met. These standards originate long before the processing plant, as the supply chain for drug manufacturing is also heavily regulated. There are only two legal drug distribution channels in the United States. The FDA oversees both the prescriptions and over-the-counter distribution of medical compounds. Again, the direct impact of the industry on the health of millions requires that the safety and quality of drugs are tightly controlled at each level of the supply chain.

Suppliers of raw materials are regulator-certified but also hold long contracts as the only provider of the material. Additionally, the raw materials and packaging materials are stored in separate locations. A company processes the raw materials entirely before the final drug is made in the manufacturing unit. A company could have one or more manufacturing units with an equal or greater number of storage warehouses. Distributors then receive the drugs and supply them to the retail agencies or entities that market and distribute them to the public. These entities include hospitals, pharmacies, clinics, healthcare care stores, and drug stores. OTC drugs can be purchased directly from a retailer, with prescription medications requiring authorization from a licensed physician.

The Regulations

The pharmaceutical sector is tightly controlled by regulations, all the way down to who can prescribe a drug or where it can be purchased. The entire life cycle for a medication is covered by a complex web of legislation, ethical guidelines and research requirements. Manufacturing is just a small part of getting medication to the masses.

Regulations address the patent applications, marketing strategies, competition from generic prescriptions and patent expiration. The regulations also address retailers, wholesalers and all prescribing physicians. Regulations have been established to monitor quality, safety, quantity, market flow, pricing, patents and research and development incentives. The involvement of the FDA and the Center for Drug Evaluation and Research have given American consumers access to the most advanced and safest pharmaceutical system in the world.

The Pricing

The prices of drugs vary, determined by the types of raw material used and the active pharmaceutical ingredients. APIs lead to more costly prescriptions, while generic drugs are a cost-effective but off-patented delivery of a similar drug without an expensive brand name attached.

Because of the involvement of regulating bodies, the drugs produced by American pharmaceutical manufacturers are safe and effective treatments. The process is controlled from start to finish to assure a positive impact on health and wellness.