Process Validation of manufacturing process of solution of NaOH 32% w/w according to EU GMP Part II

Abstract

One of the main quality requirements for GMP regulations is the process validation in order to guarantee the consumer satisfaction. Therefore, the manufacturers have to control the critical points of the manufacturing process through the qualification and validation during the product’s life cycle. The intention is to show what is the process validation and all the factors that are involved in it as well as the importance of the process validation to demonstrate that a manufacturing process is consistent and produces a product which complies with predefined specifications. For that purpose, participation on the process validation of the manufacturing of NaOH 32% w/w solution GMP has been performed. The process validation of NaOH 32% w/w GMP started in December 2017 and its ending is scheduled at the end of the 2018. Firstly, the performance of a risk assessment with the establishment of the possible risks of the process through the detailed study of the manufacturing process of NaOH 32% GMP. The identified risks have allowed the creation of cleaning and operating procedures, and the development of corrective actions to reduce the possibilities of having quality or safety issues. Secondly, the engagement in the equipment qualification of vessel. The tasks involved in it have been consisted in create and complete the documentation of Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification. Thirdly, due to the fact that NaOH 32% GMP is manufactured in multiproduct plant, the determination of Barium Hydroxide 8-Hydrate as the “worst case” through the performance of the risk analysis based on the solubility, toxicity and the hardest to clean of whole the products manufactured in the equipment in order to validate the cleaning procedure suggested. Fourthly, some improvements and recommendations has been suggested during this project as a result of the current process study performed to elaborate the Product Quality Review suchas the approach of water system qualification, the reconsideration of the products specifications and the application of a tool to collect the information obtained from the product and the process. To achieve these tasks, it has been necessary to gaining knowledge and understanding about Good Manufacturing Practices (cGMP) and the concepts of validation. This knowledge has been based on guidelines and regulations of ICH (International Council for Harmonisation), EMEA (European Medicines Agency) and FDA (Food and Drug Administration).