Process validation
Process validation is a sub-area of validation in pharmacy and refers to the collection and evaluation of data, from process design studies to commercial production . They provide certainty as to whether the analyzed process can continuously produce quality products. This control gives the manufacturer a high level of security and continuity regarding the quality of his product.
Process validation according to FDA
Since 2011, the new US guideline that the name "FDA Guidance for Industry Process Validation: General Principles and Practices" the FDA published. Although it is only officially valid in the USA, it is also a recognized guideline in Germany. The guide divides the process validation into three life cycles:
Phase 1: Process Design
In the first phase of process design, data is collected and evaluated in order to gain in-depth process knowledge. Critical process parameters and critical quality attributes are defined in this phase and incorporated into further control.
Phase 2: Process Qualification
In the second phase, the process design is evaluated to find out whether the process enables the production of a reproducible and commercial product. In addition, the final specification limits for the process must be defined. After this process, the product can be released.
Phase 3: Continued Process Verification
The third phase represents an improvement of the traditional process validation. It should show that the manufacturing process can be controlled at any time. In order to be able to implement continuous process monitoring , a system must be established that constantly monitors the ongoing process.
Web links
- Process Validation Requirements of the FDA (accessed December 1, 2014)
- Federal Ministry of Health on good manufacturing practice
- EU directive , as PDF.
literature
- G. Auterhoff, S. Throm: EU Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. 7th revised and expanded edition. Editio Cantor Verlag, 2012, ISBN 978-3-87193-418-6 .
Individual evidence
- ↑ Guidance of the FDA , as PDF.
- ↑ Continued Process Verification , information from Atris Information Systems.