Validation is an act of demonstrating a procedure, process, and activity which will consistently lead to the expected results. In pharmaceuticals there are wide varieties of procedures and processes which need to be validated. The validation process consists of identifying and testing all aspects of ...
S., and Sofer, G., Eds., Process Validation in Manufacturing of Bio- pharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies, ... AS Rathore,G Sofer 被引量: 9发表: 2005年 Single-use in the biopharmaceutical industry: A review of current technology impact, challenges and ...
Whether in the realms of pharmaceuticals, medical device production, food processing, automotive manufacturing, electronics, consumer packaged goods, or any other sector subject to stringent regulations, the significance of process validation cannot be overstated. It serves as an indispensable component for...
Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21 CFR 211) and of the GMP regulations for... RA Nash - 《Chapter》 被引量: 61发表: 2007年 Review Article - An Overview of Pharmaceutical Validation and Process Controls in Drug Dev...
Processes in pharmaceuticals are always validated, but it is subject to changes in equipment conditions, suppliers of raw materials, etc. CPV is performed to prove that process remains in validated state. For pharmaceuticals manufacturers, CPV helps to mitigate the risks of batch discards and find ...
, Process validation in manufacturing of biopharmaceuticals, Taylor and Francis, Boca Raton, Florida (2005), pp. 31-68 CrossrefGoogle Scholar [20] F. Garcia-Ochoa, E. Gomez Bioreactor scale-up and oxygen transfer rate in microbial processes: an overview Biotechnol Adv, 27 (2009), pp. 153-...
The application of process analytical technology (PAT) tools in the manufacture of pharmaceuticals is discussed. The tools are used to make measurements of the process during manufacturing and give pertinent information about physical form. The measurements made in this way give direct information on ...
All of the suggested PV enhancements can be summarized in Figure 1. Integrating the above concepts provides the basis for life cycle process development and validation (LPDV). Because development and validation have the same objectives, they can be viewed as simultaneous acti...
In many cases the “glue” that links the different process validation stages together consists of Microsoft Excel spreadsheets and PowerPoint or Word documents. While most companies have invested in a variety of systems to manage data at the different stages of the lifecycle, linking those ...
1.1. Production and control procedures, validation and other related activities may be transferred from one site to another site prior to obtaining a marketing authorization. In some cases, this transfer takes place after the approval of, for example, a product, by a regulatory authority. This tr...