News / 20 NOVEMBER 2013
AlenMed Promotion SIA successfully passed the audit to comply with international standards
On October 9, 2013 in accordance with requirements of regulation ¹ 800 «Licensing of Pharmaceutical Activities» effected as of October 19, 2011 by the Cabinet of Ministers of the Republic of Latvia, AlenMed Promotion SIA was audited on the subject of compliance with international rules of Good Distribution Practice of pharmaceutical products (hereinafter – GDP).
The audit was held by the senior inspector of pharmaceutical activities compliance department of the State Agency of Medicines.
The purpose of this audit was to learn technical aspects of AlenMed Promotion activities in wholesale medicines trade and to evaluate compliance of these aspects to the rugulation of Latvian Cabinet of Ministers ¹ 416 «Distribution and Control of Medicines» dated June 26, 2007.
The audit was based on the principles and main stipulations of GDP. Medical products quality assurance system during receipt, storage and shipping of products, employees qualifications, availability of company records: contracts, job instructions, standard operational procedures were verified. Warehouse facilities and equipment condition was inspected as well as part of the audit.
Company staff includes five employees that report to chief executive officer. Current and approved corporate organization structure of the company was presented for the attention of the auditing officer. Job instructions and employment agreements were developed for all employees of the organization (20.11.2012). All staff members regularly attend company-organized GDP standards trainings. Responsible Person trainings held in 2012 and 2013 were acknowledged by appropriate certificates (A/S „Olainfarm” and State Agency of Medicines).
The audit verified that premises, equipment, staff and company records of “AlenMed Promotion SIA” fully comply with international GDP requirements, as well as with the Cabinet of Ministers regulations ¹ 800 «Licensing of Pharmaceutical Activities» of October 19, 2011 and ¹ 416 «Distribution and Control of Medicines» dated June 26, 2007.
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