On 12 March 2003 «Grindeks» completed the milestone in its own history and in the history of Latvian pharmaceutical industry, by being the first local drug manufacturer, which received the Good Manufacturing Practice (GMP) certificate. Thereby, «Grindeks» confirmed that a Latvian pharmaceutical company can perform manufacturing process in compliance with the worldwide quality standards by investing financial and intellectual resources. GMP certificate is a guarantee of drugs’ quality.
«Grindeks» is the first company in Latvia to receive GMP certificate
Though, the idea of obligatory and statutory introduction of GMP to Latvian pharmaceutical companies became topical in the mid 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 acquisition of manufacturing process according to the world class standards; though experience gained at that time proved to be useful in early nineties when systematic work for obtaining the internationally recognised certificate began.
Investments in modernization of manufacturing and systematic work on quality improvement have ensured that already in the year 2000 the Great Britain Medicines Control Agency issued the GMP certificate to «Grindeks» for tablets and capsules manufacturing unit. This was the highest quality introduction achievement in the Baltic States among the pharmaceutical companies up to 12 March 2003, when the State Agency of Medicines issued the first Good Manufacturing Practice certificate to «Grindeks».
Implementation of the Good Manufacturing Practice requirement in the company demanded many years of work and considerable financial investments. To obtain the GMP certificate not only the end-product, i.e. the drug itself, but also the quality of manufacturing process is evaluated. When the certificate was obtained, the total investments of the implementation of GMP were approximately 14 million euros. Currently, the investments for ensuring the GMP requirements are difficult to excrete from the overall investments that amount to millions of euros – renovated premises, equipment, processes, organization of work at the stage of development and projecting are all carried out in line with the GMP requirements.
Significant resources have been invested not only into the manufacturing and control equipment modernization, but also in educating the personnel, which is of particular importance, as in the implementation of GMP it is vital to ensure that every employee is competent and able to ensure the quality of products and processes.
Why GMP is necessary?
Implementation of the Good Manufacturing Practice requirements in the manufacturing units was one of the priorities for the Latvian pharmaceutical companies before joining the EU. According to the valid laws and regulations, if drug manufacturers failed to make manufacturing processes in compliance with the GMP standards, they had to terminate drug manufacturing in Latvia. However, it would be wrong to believe that the demand of introducing GMP standards is only a whim of national competent pharmaceutical authorities and Brussels’ bureaucrats.
Compliance with the Good Manufacturing Practice standards is in the interests of patients, since it is the direct evidence that a medicine is effective and safe, and will not cause any unpredicted side effects for the patient.
Compliance with the GMP is necessary for drug manufacturers themselves, since it confirms that the company manufactures high-quality products, moreover, it opens the business prospects in markets, where the company could not operate particularly because of absence of the certificate.