Making Medicines Is a Complicated, Highly Regulated Process

If there is one thing that has been a theme throughout history, it’s that people are always looking for ways to relieve their pain and feel better. In ancient times, it was done with herbs and other plants. Later, things such as alcohol and mind-altering drugs were discovered. It wasn’t until the 20th century, however, that a regulated, mass-produced pharmaceutical industry developed to produce both prescription and over the counter medicines. Nowhere in the world is that industry as big as in the United States, which has nearly half of the global pharmaceutical market. To ensure the manufacturing of both prescription and over the counter medicines is safe, manufacturers have to follow a number of rules and regulations.

One of the main regulations is the quality of the products themselves. In the U.S., the Food and Drug Administration regulates the quality and safety of medicines. Any drug or other substance that wants to be able to make a claim that it cures disease or relieves symptoms must be regulated by the FDA. Before they can ever reach the manufacturing stage, drugs must go through rigorous study and testing to ensure they work and have minimal side effects. Once a drug is being made, FDA regulation typically focuses on safety and quality.

During the manufacturing process, drug makers have to follow a number of other rules and best practices. For example, manufacturers must follow good manufacturing practices for active pharmaceutical ingredients, or GMP API manufacturing practices. GMP API manufacturing practices ensure the drug has the right amount of the ingredient or ingredients of the substance that produces the result it promises. Following GMP quality control standards, including those for GMP storage of ingredients, is an important part of the process.

Beyond GMP quality assurance standards and other GMP standards, there are a number of other standards on which drug manufacturers need to concentrate. For example, there are requirements for things such as how much air pollution and humidity are allowed in manufacturing areas. For example, ISO 1 clean room standards allow just 12 particles for each cubic meter of 0.3 micrometer and smaller.

Any company that wants to be in the pharmaceutical manufacturing industry has to realize the investment in time and money that it will take. Meeting all the requirements can take years and millions of dollars in investment before any products roll off the production line.

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