Active pharmaceutical ingredient program

Safety Production of the requisite drug molecule, called the active pharmaceutical ingredient (API) or bulk pharmaceutical chemical (BPC), may involve materials, solvents, or intermediates that are volatile, toxic, or even explosive. The development program has to determine the appropriate manufacturing processes to ensure that safety is not compromised and the API can be produced and purified to remove impurities and toxic residues. 

Chemical Development s primary objective is to provide quality active pharmaceutical ingredients (APIs) for company Therapeutic Team programs, on time... 

When pharmaceutical ingredients (both active and excipient) are made part of a pharmaceutical dosage, they are now components of a separate drug product stability program. 

Although the CIR process is sponsored by the CTFA, the latter will conduct safety studies for substances considered crucial to the survival of the cosmetic industry. The CTFA will also establish and pay for research required to confirm the stability, chemical purity, and safety of various cosmetic ingredients. These activities are part of the cosmetic industry s technically oriented self-regulation program. Similar programs exist in the pharmaceutical industry. 

---