REVIEW, CHARACTERISTICS AND ANALYSIS OF THE LAST CHANGES IN THE GMP REQUIREMENTS

Abstract

The regulatory requirements are constantly increasing in the medicines manufacturing sphere, which is reflected in the good manufacturing practice rules. The changes in the GMP regulations relating to personnel, premises and equipment, production, quality control, complaints, quality defects and product recalls, as well as a new version of qualification and validation annex and certification by a Qualified Person and batch release annex have been characterized and analyzed in a review. The related information sources have also been analyzed in order to facilitate the interpretation and implementation of these innovations in the practice of company-producers and, in the long term, the work of the regulatory authorities. The review provides recommendations on the priorities and points of application of efforts to implement the changes discussed.

Keywords

• good manufacturing practice
• changes in the requirements
• validation
• cross-contamination