Good Manufacturing Practice

On 12 March 2003 «Grindeks» made the milestone in own history and in history of the entire Latvian pharmacy industry, by being the first domestic drug manufacturer, which received the Good Manufacturing Practice (GMP - Good Manufacturing Practice) certificate. Thereby, «Grindeks» has proved that a Latvian pharmaceutical company invested financial and intellectual resources can perform manufacturing process in compliance with the worldwide quality standards. GMP certificate is a guarantee of drugs’ quality.

«Grindeks» is the first company received GMP certificate
Though, the idea of obligatory and statutory introduction of GMP to Latvian pharmaceutical companies had become topical in the mid of nineties, «Grindeks» commenced introducing these standards already in seventies. This was necessary to ensure export of original product of «Grindeks» - Ftorafur. Surely, these were only the first steps in application of the gained that time proved useful in early nineties in systematic work for the internationally recognised certificate.

Implementation of the Goods Manufacturing Practice standards at the company demanded many years of work and considerable financial investments. Not only the end-product, i.e. the drug itself, was estimated to receive the GMP certificate, but the entire manufacturing process. Totally, the company invested to GMP about LVL 10m. Big investments have been made to manufacturing facilities improvement as well as personnel education. Personnel education is of particular importance, since introducing GMP it is vital to ensure every employee knew and complied with the high-quality production principles.

Investments to manufacturing upgrade and systematic quality improvement have ensured that already in the year 2000 the Great Britain Medicines Control Agency issued to «Grindeks» the GMP certificate for tables and capsule manufacturing. This was the highest quality introduction achievement among the Latvian pharmaceutical companies almost by 12 March 2003, when the State Agency of Medicines issued to «Grindeks» the Good Manufacturing Practice certificate under the number one. 

Why GMP is necessary?
Introduction of the Good Manufacturing Practice standards for manufacturing before joining the EU was one of the priorities for the Latvian pharmaceutical companies. Pursuant to the effective laws and regulations, if drug manufacturers failed to make manufacturing process complying with the GMP standards, they had to terminate drug manufacturing in Latvia. However, it would not be fair to think that demand to introduce GMP standards is only a fancy of national competent pharmaceutical authorities and Brussels’ bureaucrats.  Compliance with the Good Manufacturing Practice standards is in the interests of medicines consumers, since it is the direct evidence that a medicine is safe and will not cause any side effects. Compliance with the GMP is necessary for drug manufacturers themselves, since it proves that the company manufacturers high-quality products, moreover, it opens the business prospects in the market, where the company could not operate particularly because of absent certificate.