Process Validation

Process Robustness in Pharmaceutical Manufacturing
November 4, 2010 | Process Validation, Validation Articles
The objective of this study is to unify understanding of the current concepts of process robustness and application of robustness principles to non-sterile solid dosage form manufacturing. Process robustness activities start at the earliest stages of process design and continue throughout the life of the product, it suggests greater process certainty in terms of yields, [...]
Critical Parameters Affecting Process Validation
September 27, 2010 | Process Validation, Validation Articles
Validation is an integral part of quality assurance; it involves systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. Validation in itself does not improve processes but confirms that the processes have been properly developed and are under control. Adequate validation is beneficial [...]
A Simple Approach to Stability Chamber Qualification
April 27, 2010 | Process Validation, Validation Articles
So you just bought a new stability chamber for your facilities. Usually you can buy also the initial qualification from the vendor, or choose to do it internally by your validation team. The purpose of this article is to describe a simple approach for stability chambers qualification. Overall Approach The basics of all qualifications are [...]
Packaging Validation – A Simple Example
November 9, 2009 | Process Validation, Validation Articles
Once upon a time, a company decided to improve their packaging sealing process. They selected equipment with a new technology that would process more products in less time with improved seal characteristics. The equipment was specified and approved. A qualification project team was formed and prepared a validation project plan that described how the revised [...]
Water Generation and Distribution System Qualification Program
November 13, 2009 | Process Validation, Validation Articles
The Water generation and distribution system has very high importance in Pharmaceuticals and it becomes very critical when it is a injectable unit. The qualification procedure of the water generation and distribution system is well described in the various guidelines. The water system is qualified through the various Phases Phase I, Phase II and Phase [...]