Open AccessCLEANING VALIDATION- PREREQUISITE OF QUALITY IN DIETARY SUPPLEMENTS
Author(s) -
Davor J KoroÄok,
Olivera Čolić,
Nada Tršić Milanović
Publication year - 2017
Publication title -
advanced quality
Language(s) - English
Resource type - Journals
eISSN - 2217-8538
pISSN - 2217-8155
DOI - 10.25137/ijaq.n1.v44.y2016.p59-62
Subject(s) - process validation , quality (philosophy) , pharmaceutical manufacturing , process (computing) , product (mathematics) , risk analysis (engineering) , manufacturing process , critical quality attributes , protocol (science) , computer science , manufacturing engineering , process management , process engineering , operations management , engineering , business , medicine , verification and validation , downstream (manufacturing) , philosophy , materials science , geometry , mathematics , alternative medicine , epistemology , composite material , pathology , pharmacology , operating system
Manufacturers of dietary supplements meet growing regulatory demands for control of the production process, with the main goal of launching a quality based product, by which they ensure user’s protection and contentment. Demand for cleaning validation represents a multidisciplinary activity that brings together experts from around the world with a common goal: to ensure the efficacy of the cleaning operation in pharmaceutical manufacturing. Main goal of this work is to describe cleaning validation process in the manufacturing sector of liquid pharmaceutical forms- that consists of syrup and spray manufacturing. Pursuant to all guidelines of the European and National regulations, cleaning validation was initiated by designing Validation plan and Risk assessment plan for the manufacturing line of liquid pharmaceutical forms. Specified processes of cleaning were used, while specific physical, chemical and microbiological parameters were followed, and the process was complimented by a Validation protocol that documented three consecutive washing c ycles; directed at three consecutive batches of the same products on that manufacturing line for sprays. Final report of the validation process is being coordinated, followed and improved by the Quality sector. This enabled validation and efficacy of the chosen cleaning processes, but certain parameters were still being followed and analysed in order to prove conformity and/or allow changes that might arise. A goal of the pharmaceutical company to produce quality and safe products is achieved by applying principles of cleaning validation, and by using and mproving established cleaning procedures.