Cleaning validation in analytical development: Current challenges and future prospectives

2020 ◽  
Vol 7 (3) ◽  
pp. 113-118
Author(s):  
Bikash Ranjan Jena ◽  
◽  
Suryakanta Swain ◽  
Debi Prasad Pradhan ◽  
Debashish Ghose ◽  
...  
1988 ◽  
Author(s):  
Alexander H. Levis ◽  
Jeff T. Casey ◽  
Anne-Claire Louvet

Author(s):  
Matthew J. Smith ◽  
Carl S. Byington ◽  
Matthew J. Watson ◽  
Sudarshan Bharadwaj ◽  
Genna Swerdon ◽  
...  

AIAA Journal ◽  
10.2514/2.511 ◽  
1998 ◽  
Vol 36 (7) ◽  
pp. 1279-1285 ◽  
Author(s):  
Hiroshi Suemasu ◽  
Tatsuya Kumagai ◽  
Katsuhisa Gozu

1998 ◽  
Vol 20 (3) ◽  
pp. 87-89
Author(s):  
Stephen Scypinski ◽  
John Baiano ◽  
Theodore Sadlowski

Projects that require analytical support can evolve from a number of different situations, for example new molecular entities from drug discovery; process changes; packaging changes; site changes; line extensions; and inlicensed projects and compounds. Laboratory automation has been shown to provide a viable and practical solution to assisting in analytical development. However, it is not always the most logical answer. A truly flexible and responsive analytical unit will make a decision on a case-by-case basis, when faced with a new project, whether it is best to: automate some or all aspects/testing involved; contract out to a reputable and approved contract research organization (CRO); hire temporary help; use available in-house resources; use a combination of the options shown above (for example to evaluate the complexity of the new project versus what the in-house resources are currently working on). The paper discusses the advantages and disadvantages of the various options with respect to providing analytical support and suggests optionsfor the most effective use of resources. The role of automation as one of the important tools in the arsenal of these options is highlighted.


2012 ◽  
Vol 75 (4) ◽  
pp. AB391
Author(s):  
Lúcia H. Tomiato ◽  
Mirtes L. Leichsenring
Keyword(s):  

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