Harmonization of Inspection Supervision in the Pharmaceutical Sector of the Republic of Macedonia in conformity with the Recommendations of the European Legislation and WHO

Abstract

The new Law on Inspection Supervision (Official Gazette 50/2010, implementation as of 1.04.2011) was passed in April 2010 with the aim of improving the quality of inspection in the pharmaceutical sector, as well. The new Law covers the spectrum of weaknesses recognized over time. The system of quality inspection encompasses a set of commonly required quality management process, objectives, conditions, policies, formal rules and procedures. The organizational scheme addresses all aspects of inspection activity. The inspection service has to assure that its personnel are not under any undue internal or external commercial, financial or other kind of pressure and influence that may adversely affect the quality of their work. Moreover, the inspection service needs a sufficient number of employees with the necessary education, training, technical knowledge and experience to perform inspection activities according to specified requirements and standards. An inspector’s engagements have to be within the scope of the responsibilities arising from his/her activities. Continued training in inspection activities should be established, including advanced training programs that offer various levels of inspectors’ qualification. In regard to their specific activity, new rule books governing inspection supervision in the pharmaceutical sector should be developed and adopted in the near future. This permanent upgrading process of the existing national policies in compliance with the EU legal policy has also become characteristic of the Macedonian pharmaceutical sector.