Comparison of requirements of annex 1 to the rules of good manufacturing practice of the Eurasian Economic Union and requirements of the draft annex 1 GMP PIC/S
This article provides an overview on draft GMP EC Annex 1 revision progress and, as a consequence, the GMP PIC/S. The role and position of Russia in the pharmaceutical market, its inclusion in international organizations involved in the regulation of the production and circulation of drugs has been indicated. The interconnection between economic integration processes, changes in international regulatory requirements and national legislation has been demonstrated. The article shows how changes in the laws governing the pharmaceutical industry entail changes in the organization of manufacturing or in the approach to the manufacturing process at the organizational level and/or lead to material expenses to eliminate incompliance. Keeping track of possible future changes in legislation allows to pre-build a plan for eliminating incompliance. When analyzing the changes in the Draft Appendix 1 regarding the current version of Appendix 1, it has been revealed that the documents have significant differences. To eliminate significant incompliances with a number of paragraphs of the draft Appendix 1, it is necessary to make changes not only in the operating procedures, but also in the planning solutions of production sites. Based on the results of the work carried out, it has been established that the introduction of the draft Annex 1 GMP PIC/S and its implementation in the GMP EAEU requirements will lead to incompliance at existing pharmaceutical enterprises, the elimination of which requires a lot of organizational work. Significant changes at the existing enterprise are required in accordance with 14 points of the draft. This article presents clauses 5.9, clause 5.21, clause 8.7, clause 8.16, clause 8.29, clause 9.17, clause 9.33 - this is due to that most of these requirements are absent in the current valid requirements of GMP EAEU and Russian GMP rules. The comparison made is an occasion for pharmaceutical companies to conduct internal audits for compliance with the requirements of the draft GMP PIC/S Annex 1 in order to preventively identify incompliances and develop an action plan to address them.