Tag Archive: Compliance

What is GMP Compliance in a Pharmaceutical Company?

The U.S. pharmaceutical sector holds over 45 percent of the world’s pharmaceutical market. It plays a key role in the healthcare system and public health issues.

There are approximately 56,000 community-based pharmacies in the United States according to the International Academy of Compounding Pharmacists. An estimated 7,500 compounding pharmacies provide advanced compounding services of which 3,000 of them provide sterile compounding.

Regulations for Compound Pharmacies:

Regulatory oversight has been taken up by various governmental and state boards that consider the various processes that go about within the pharmacy sector. Compounding pharmaceutical companies are heavily regulated to ensure they are complying with federal and state safety laws. Drugs are tested for efficacy, safety, and minimal side effects. Testing, (which include three clinical trials) can span from 10 to 15 years before being approved and marketed to the public.

Regulating agencies in the U.S. has been taken up by two different