Our blog offers much more than just information about interpreting and translating between Russian, English, and German. Here, we share our insights from GMP inspections by foreign authorities and provide valuable recommendations on how to successfully pass your GMP inspection or audit. You will also periodically receive useful information about the Russian and Belarusian pharmaceutical markets and the market of the Eurasian Economic Union (EAEU). As enthusiastic pharmaceutical interpreters and GMP translators, we are excited to share valuable information about the history of the world's largest pharmaceutical manufacturers and their secrets to success.
Founded in 1876 as a small pharmacy with four employees, Eli Lilly grew into a true pharmaceutical giant over the 100 years that followed. One of the first medicinal products manufactured was the antimalarial drug quinine.
Today, the US company Eli Lilly produces and distributes a wide range of modern medicines worldwide - naturally in accordance with the applicable GMP guidelines. As a globally operating pharmaceutical manufacturer, Eli Lilly must repeatedly undergo GMP inspections by authorities, including those from Germany, Russia and China.
Born in Baltimore in 1838, Eli Lilly discovered his passion for chemistry at an early age. During a family visit to Lafayette in 1854, he observed the local pharmacist Henry Lawrence preparing medicinal products and was fascinated. Lawrence then offered him an apprenticeship as a chemist and pharmacist, which Eli Lilly successfully completed after four years. Years of transition followed until Lilly opened his own pharmacy in January 1861. However, the American Civil War threw a monkey wrench in the works. After the war began, he fought for the Union the side (i.e. the northern states). Eli Lilly was taken prisoner in September 1864, was released after a few months and then promoted to colonel shortly before his discharge from the army in the summer of 1865. He proudly carried the title of colonel until the end of his life.
More years of upheaval followed.. Lilly tried his hand at owning a cotton plantation, but eventually returned to his roots. In 1869, he reopened his own pharmacy with a business partner. However, Eli Lilly soon realized that his interest was not in the pharmacy business - but in the actual manufacture of medicines. In the end, he left the profitable business behind and opened his own laboratory in Indianapolis in May 1876. With three employees, including his son Josiah, Eli Lilly began manufacturing medicinal products.
His approach to the production of medicinal products, which seems self-evident today and is part of GMP-compliant manufacturing, was extremely innovative at the time. Lilly produced sugar-coated tablets that were easier to swallow, was one of the first to use gelatine capsules to achieve a consistently correct dosage and indicate the ingredients of its medicinal products on their labels. Even though the term did not exist at the time, Eli Lilly can be considered one of the pioneers of Good Manufacturing Practice, and the points listed are now an integral part of every GMP inspection - whether by the FDA, the EMA or the Russian authority SID&GP.
After the death of its founder in 1898, his son Josiah K. Lilly took over the company, which had grown considerably by that time. It was under his leadership that the company became one of the largest pharmaceutical manufacturers in the USA. The company underwent several waves of modernization and production expansion. J.K. Lilly extended the innovative approach of standardization to the actual manufacturing processes - a further step towards GMP. The major breakthrough with a product came in 1923, when the world's first insulin preparation was launched on the market. This meant that the previously fatal metabolic disease diabetes mellitus could finally be treated. In 1943, the pharmaceutical company developed a method for the mass production of penicillin. At the beginning of the 1950s, Eli Lilly and Company established itself as a leading pharmaceutical manufacturer. The need for translators and translators and interpreters was still low at the time, as the age of internationalization and the introduction of GMP standards was yet to come.
The international expansion of Eli Lilly and Company began, slowly at first, in the 1960s. The company is now represented in numerous countries in North and South America, Europe and Asia and also manufactures worldwide. The product range now also includes medicinal products for the treatment of cancer, depression, sleep disorders and chronic pain. However, with global activities, the controls have also become more international. While Eli Lilly used to be exclusively under the jurisdiction of the FDA, compliance with GMP standards is now also inspected by authorities in the EU, Russia, China and Brazil. GMP inspections require the use of competent language mediators who can expertly translate or interpret complex topics of good manufacturing practice into the respective national language. We would be happy to support you should our services be required!
Image: de.wikipedia.org