Teva CFS Book English

* 18 Already at the end of the seventies, the procedural infrastructure for organized work at a pharmaceutical company was laid at the Ikapharm plant and this became validated after the plant was bought by Teva. those weeks. By the end of the inspection we knew that the results would be good, the inspectors praised all the systems that were built and the personnel, and they said that the plant was at a very high level”. Also in 2005, FDA inspectors performed a significant inspection at the plant, which lasted 3 weeks. The inspection took place at a time when the plant launched products almost weekly (see the article “A Miracle Making Plant” on the cover of “Getting It Done Together”). The need to continue working hard concurrent to the natural vigilance that an inspection evokes, were quite a challenge for the teams, but also this time the professional work and the cooperation proved themselves, and the inspection passed successfully. So, since the early 90s, once every year- two years, an FDA inspection takes place at the plant, and the infrastructures that were laid sometime in the 80s continue to be a foundation for success and leadership. What is the FDA? The American Food and Drug Administration, or FDA for short, is a government body subject to the United States Health and Human Services Department, which concentrates the inspection and regulation of food and drug products for humans and animals, cosmetics, medical instrumentation, and more. The body has significant international clout and FDA approval is a condition for drug approval for use in numerous countries. Only companies that meet and implement the requirements will be prepared for inspections by FDA representatives which are carried out at an increasing frequency. If the company does not perform well in the inspection, it may entail severe consequences, such as discontinued export approval to the U.S., damage to the organization’s / product’s image, and of course financial damage, and this is where the importance of being properly prepared for the inspection lies.