According to ICH Q7A Active Pharmaceutical Ingredient (API) is defined as “Any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body”
Active Pharmaceutical Ingredient
According to ICH Q7A Active Pharmaceutical Ingredient (API) is defined as “Any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body”.
The market of the API grows up recently in parallel with the fast growing of the pharmaceutical industry which led to integration and specialization of this industry. The World Health Organization (WHO) Technical Report Series, No. 953, 2009 Annex 2 described the stability testing of API and Finished Pharmaceutical Products (FPP) concluding that both of them are co-related. The WHO guidelines has two main sections one for API and the other section for FPP describing all the required testing for both materials. Recently the Food and Drug Administration in the United States of America embrace the ICH Q7A guidelines for the API and produce a compliance program guidance manual.
Nusim, S. discussed the issue of API in a book titled “Active Pharmaceutical Ingredients: Development, Manufacturing and Regulation”. So many factors should be considered when discussing the API issue which can be listed as:
•Bulk Drugs: Process design, Technology Transfer, and First Manufacture.
•Design and construction of facilities.
•Quality Assurance and Control.
All those factors together considered to be the core subject of the API. India is one of the leading countries of manufacturing of API but another strong competitor appears on the field; China; which even motivates the FDA to open three offices in China mainland (Beijing, Shanghai and Guangzhou). In a FDA seminar held in China Pharmaceutical University, on the 11th of March 2011, Dr. Brenda the director of FDA office in Beijing presented a seminar about implementation of current good manufacturing practice (CGMP) on improving the healthcare. She talked about how the FDA in China is trying to promote the ideas between governmental authorities and pharmaceutical manufacturers so as to stick to the CGMP and FDA guidance so as to improve the quality of both API and FPP. I asked Dr. Brenda about if the FDA in China offered any sort of motivations to encourage the Chinese pharmaceutical manufacturers to adopt the CGMP and FDA guidance. The answer was simply that they will get a letter of warranty if they violet the FDA regulations assuming that those manufacturers had been approved before by the FDA. My opinion is opening FDA office itself is motivation because it is just like the FDA interested in the Chinese market but it should according to the CGMP and FDA guidance.
Finally, we should consider all the above mentioned factors when we want to talk about API putting in mind some of those factors are correlated to the FPP.
1.PROGRAM 7356.002F. FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL, 2008.
2.Preparations., W.E.C.o.S.c.f.P., Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO Technical Report Series, 2009(953).
4.Nusim, S., Active pharmaceutical ingredients : development, manufacturing, and regulation. 2nd ed. Drugs and the pharmaceutical sciences. 2010, New York: Informa Healthcare. xv, 433 p.