Continuous Manufacturing from Development to Operation - Live Online
19/20 October 2021
Course No. 17506
All times mentioned are CEST.
Objectives
It is the aim of this event to show how a continuous manufacturing process for oral solid dosage forms can be developed and set into operation. Questions regarding materials, technology, process controls and GMP/Quality Assurance will be discussed and answered.
Background
Solid dosage forms are still the most common dosage form, first and foremost tablets without any pioneering developments in the recent years. But driven by only a few pharmaceutical companies more and more of the global players started to invest in continuous manufacturing (CM). Companies like Johnson & Johnson, Vertex, Pfizer and Merck work intensively on the development of continuous processes with some products already approved. This change from batch-to-batch to the continuous mode of operation is one of the largest paradigm changes in the pharmaceutical industry ever. Continuous manufacturing is data driven and by gaining this flood of information two topics become very important: process control and process monitoring. The residence time of the materials processed becomes another important quality aspect. Time now also is the most important parameter for scale-up, not the volume of the equipment any more. So a large amount of data has to be evaluated in order to control the process and to decide whether material can be collected or has to be rejected. This fundamental shift is also a major challenge for the Quality Unit. The Quality Management System has to be adapted to also cover continuous processes. Regulating authorities, first of all the FDA, also encourage the transition from batch to continuous production. They expect an increase in product safety while equipment suppliers promote a decrease of production costs. Pharmaceutical companies emphasis the savings of time and materials needed during the development and transfer phases. But with a continuous mode of operation new questions rise:
How should a batch be defined? Is there a difference between lot and batch?
What are the prerequisites for the development of a continuous process?
What new risks does a continuous process involve?
How can a continuous manufacturing line look like?
How can a continuous process be kept in a controlled state?
How is a continuous process validated?
How to determine the ResidenceTimeDistribution – what about material traceability?
How should deviations in a continuous process be handled?
How should equipment cleaning and maintenance be scheduled?
Which documents do the authorities require for approval of continuous processes?
Listen to companies who already did the transition and learn how they answered the questions above.
Target Group
This conference addresses specialists and executives working in the fields of pharmaceutical development, manufacture and quality assurance as well as technicians, planners and plant designers, especially those involved in the set up of continuous lines for manufacture of oral solid dosage forms.
Technical Requirements
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Seminar Programme as PDF