GDP & European debate GMP- Practice and Experience

Wednesday, October 28, 2015, held at the Hotel Epoque International Symposium & GMP GDP - Practice and Experience European organized by Tarus Media in partnership with VTU Engineeering Austria, under the auspices of the National Agency for Medicines and Medical Devices.

GDP & European debate GMP- Practice and Experience with international participants stressed the importance of implementing good practice on drug distribution (GDP) for human use, in accordance with EU regulations. The event was attended by representatives of Romanian authorities, manufacturers and distributors, importers and players in the pharmaceutical market, which discussed storage conditions of medicines, the application of a quality management system that includes procedures and records rules.

Gabriela RUJA, pharmacist and inspector for best practices in the distribution and production of drugs within ANMDM, gave a detailed presentation on the new best practice guide published in our country in July. ANMDM representative said that the new guidelines GDP - the rules of good distribution practice of medicinal products - was approved by the Minister of Health 761/2015, published in Official Gazette on July 2, and transpose European guide which was published in March 2013, with term implementation in September 2013.

This was confirmed by Simona Manole quality Farmaceutica Remedia manager, who admitted that the new guide does not involve major changes. "Do not essentially different things. Basically, there are very significant differences. Because the old regulations were a pretty high standard - and we, of course, I was practically under that regu- this shift would only lead us to review our work, we impose certain qualifications, validation of equipment. (...) No new changes in this new guide, differences involving investments or reorganizations of business or company, "said Simona MANOLE.

In the symposium also addressed issues relating to GMP & GDP representatives of the Austrian company VTU Engineering.

Gubitz Brigitte talked about risk management, presenting demands, challenges and impacts GMP qualification. "As global production increases, so does the risk. We also have longer supply chains, seasonal variations in temperature, the distribution network is complex, often involving multiple countries, which implies differences in expertise, infrastructure and equipment. Lucam with major companies within them realize workshops, to help them define their process management and improve it, which saves time and money, "said Gubitz.

Karin Kaltseis gave a presentation about the storage and distribution, focusing on care for pharmaceuticals sensitive and director VTU Group, Robert Schwartz presented the company's activity comprising a wide range of interventions to small-scale projects aimed at improving performance of factories to extensive consulting projects within large pharmaceutical companies (which include Sandoz, Baxter, Boehringer Ingelheim). VTU Group has over 400 employees in German, Switzerland, Austria, Italy, Romania and Malaysia.

Symposium conclusions were drawn by Dr. Marius TANASA, vice president of the National Agency for Medicines and Medical Devices, which was in Mrs consent. Gabriela RUJA the fact that wholesale distributors of drugs will have to renew their licenses in two years after authorization revised rules will come under new rules of good distribution practice for medicinal products (GDP).