Biotechnology Regulations Skills

cGMP stands for current Good Manufacturing Practices. GMPs apply to industries that produce pharmaceuticals, food, and beverages. The FDA publishes guidances to help companies understand how they view the regulations related to drug manufacturing. Since FDA's thinking evolves, it is important to ...

Follow Good Clinical Practices in working with patients and protecting human subjects.

Companies that conduct pre-clinical research must comply with Good Laboratory Practices. In a company, GLPs are part of a quality system that covers the process and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived.

Companies that manufacture substances regulated by the FDA must adhere to Good Manufacturing Practices (GMPs). Good Documentation Practices (GDP) are important in recording and managing data related to test results.

The International Council on Harmonization Good Clinical Practice guidelines (ICH-GCP) cover quailty, efficacy, safety, and cross-cutting topics. The International Council on Harmonization (ICH) is a non-profit group that works to ensure that safe, effective, and high quality medicines are developed ...

The FDA protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the U.Ss food supply, cosmetics, and products that emit radiation. They also regulate tobacco. Many biotechnology ...