GMP Inspection

GMP Inspection

Poster

Ivan Ivanov, Krasen Velev, Emil Hristov, Kalina Andreevska
Chemistry and Pharmacy faculty, Sofia University “St. Kliment Ohridski, Bulgaria

Aim: To study and present the basic procedures for conducting GMP inspections of active substances and medicinal products. Materials and methods: A documentary analysis was conducted. The Guidance on "Compilation of Community Procedures on Inspections and Exchange of Information", the European Commission Health & Consumer Protection Directorate-General Public Health and Risk Assessment Pharmaceuticals and Directive 2001/83 / EC wеre used. Results: GMP is a system of internationally recognized business rules that covers all aspects of production: personnel, premises, facilities, materials, documentation, quality control and aims to ensure safety, efficiency and compliance with the specification. The GMP Inspection Guide outlines the requirements for developing a quality system for use by GMP inspectors. The main objective of the quality system is to ensure that adequate quality standards and a common standard of requirements are maintained in order to achieve compliance in the inspection standards between the GMP National Pharmaceutical Inspectorates and thus facilitate the mutual recognition of these inspectorates in the European Economic Area. The inspector's primary role is to ensure that manufacturers comply with GMP principles and guidelines, including licensing provisions, marketing and manufacturing authorizations, and determine whether the various elements of the quality assurance system are effective and appropriate to comply with the principles of the GMP. Conclusion: In accordance with Directive 2001/83 / EC inspections of manufacturers and importers of medicinal products are carried out which main role is to ensure that the quality of the products is in accordance with GMP.
Keywords: Inspection, Audit, Certified Auditor, Report, Quality