Quality manager

Joint Venture «Novopharma Plus Ltd», Tashkent.

The company has obtained the certificate ISO 9001, following one certificatory and two supervisory audits. The present certificate is valid until 21.02.2010.The company has implemented and successfully uses Quality Management System and complies with the requirements of the standard DIN EN ISO 13485:2003 and the directive EC 2003/94/EC, which determines the principles and norms of good manufacturing practice in production of medical products / pharmaceuticals for humans. All this information is fully presented on www.novopharma.uz.

• I started my work as the Head of the documentation sector of the Quality Management Department of the pharmaceutical company Novopharma Plus. For the period of 3 months I was in charge of writing and editing SOPs for the manufacturing department of the company. Due to the nature of those tasks I had to get closely acquainted with the principal documents of Quality Management System: Quality Manual, Quality Policy and Quality Objectives. In collaboration with other departments and support services we prepared the company for the certification ISO 9001.

• We passed the certification successfully in February 2007, got the certificate from the company DQS that made sure that our quality management systems complied with the international standards of ISO 9001. This certificate is valid up to 2010. There were a few disparities found during the certification audit process, but all of them were duly rectified. In the course of the written communication with the auditor, all the rectification were accepted and the company received its certificate.

• In a year’s time there was another audit, carried out by the representative of DQS in Tashkent. During this year we prepared, created, edited and distributed among the managers 8 main processes and 6 procedures of the quality management system. Quality Manual, Quality Policy and Quality Procedures were corrected and updated accordingly. During the second audit together with the auditor I took active part in checking the marketing and purchasing processes.

• Last year the representatives of DQS organized a training course on the international standards of quality management ISO 9001-2000. Upon the completion and passing the relevant tests, I was awarded the diploma of Quality Manager. In addition to that, the company sent me on GMP (manufacturing of pharmaceuticals in accordance with good manufacturing practice) organized by Pharmaceuticals’ Committee. I received a participation certificate. I also assisted at the seminar prepared by IntercertConsult on the Introduction to Ecological Management ISO 14000.

• In April 2007 the company has passed the certification for GMP and ISO 13485-2003, which served as a further impulse for improvement and development of the quality management system. This certificate was also issued by DQS GmbH. The professional auditors from Germany came twice: first time in April 2007 and second time in a year, in spring 2008. Master Plan was prepared and approved, the procedures of validation, cleanliness and health and safety were hugely improved and the work for risk analysis and management was started.

• My participation included working on and editing the process of infrastructure management. The Register Cards for the equipment have been designed and introduced. They include the main technical characteristics, size, resources used and color photo of each machine. In addition to these register cards we prepared the main floor plan of the equipment in the two main manufacturing shops and in the conditioning room, filled in the register logs for technical service and necessary spare parts orders.

• All this was done in order to rectify the deficiencies in the Preventive Maintenance Plan. We also gathered and systematized all the existing operating instructions, technical schemes, certificates, operations manuals into two big files. Apart from that we prepared a file consolidating all the technological equipment, including all

developed and approved validation protocols.

• The organization chart of the company has been designed, taking into account all business processes, horizontal links and lines of communication.

• During the course of this work I independently developed and created an electronic database in Access 2003, which allows easy

use, control and updating of the data.

• This database stores all scanned documentation for quality control system, it also contains real dates, signatures and different versions of all documents. The database allows to track in a very short time to who, when and what controlled copy has ever been

given.

• Through the inquiries created it is possible to print a report for any given period of time, see what documents have been issued and to who. Any document can be quickly sent in electronic form by e-mail. This makes work much easier, especially in terms of updating the data, taking out of circulation the out-of-date versions of the documents and distributing the new versions effectively.

• We have acquired the basic Standard (122 units) through UzStandart on QMS. We have the foundation for the updating of necessary documentation for the companies.

• At the moment the company is preparing for the reform of the ampoule manufacturing sector, expansion of the catalogue of the currently manufactured products.

• Thank you for attention