The United States produces more chemical products than any other country in the world. Pharmaceutical manufacturing involves the synthesis of active pharmaceutical ingredients (API) according to good manufacturing practice (GMP). Companies that offer API GMP solutions, tritium (3H) labeling, and carbon 14 (c14) radiolabeling (labeling with a radioactive atom or substance) can manufacture carbon isotope 14 (14C) and tritium radiolabeled APIs. This allows studies to be conducted for the Food and Drug Administration (FDA) phases 0, I and II microdosing and mass balance. These companies perform API GMP tests for synthesis, purification, and other testing to comply with FDA guidelines. Companies that provide this testing may also offer GMP storage for customers’ pharmaceutical compounds.
Through the processes of GMP synthesis and other testing, a company that provides API GMI solutions examines radiolabeled APIs that have been manufactured or purified according to the rules of GMP. State-of-the-art analytical equipment is used to examine the pharmaceutical compounds and the compounds are given a full batch record, including records of synthetic and purification practices from beginning to end.
All syntheses, storage, and other processes should be conducted in certified GMP suites. APIs should be examined with the right kind of high-performance liquid chromatography (HPLC), nuclear magnetic resonance (NMR), and mass spectrometry (MS) equipment.
Production of APIs should be carried out in compliance with FDA GMP rules. The APIs should be designed for use in clinical studies. 14C and 3H API should be quarantined and then released according to high standards of quality assurance. The mode of transfer should be analytical, and analytical practices should be validated.
Syntheses are to be performed in a high-performance GMP suite, with validation of the clean area of production. Standard operating procedures should govern major activities. New glass materials are to be used in syntheses. Here, too, APIs should be quarantined and then released according to high-quality assurance standards. Purifying though GMP HPLC should include all relevant equipment, including tubing and glassware. A master batch record should include all relevant records.
Pharmaceutical manufacturing requires adherence to strict standards of quality and must follow FDA guidelines. Good manufacturing practice is essential to the process of synthesizing active pharmaceutical ingredients. Contact us to learn more.