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GMP Manufacturing

Aseptic Processing of Sterile Medicinal Products
What requirements are rooms and personnel expected to meet for aseptic processing?

NEW ++ NEW ++ NEW

 
 
Microbiological Monitoring in Pharmaceutical Manufacturing
Which microbial contamination risks must be anticipated during the manufacture of sterile preparations?

NEW ++ NEW ++ NEW

 
 
The Process of Freeze-Drying
How is freeze-drying performed and what are the relevant process parameters to be measured?

NEW ++ NEW ++ NEW

 
 
GMP-Questionnaire: Contract manufacturing / Contract analysis
GMP-Questionnaire: Contract manufacturing / Contract analysis
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with references to regulations for preparing and carrying out GDP audits

 
 
 
Premises
Official requirements | material flow | personnel flow and layout | room classes | construction elements | barrier systems and isolators | and much more...

 
 
Practical Aseptic Processing Fill and Finish - Volume I and II
These books provide an overview of the aseptic process in the pharmaceutical industry. This process has received a lot of attention, since it is the most demanding of manufacturing processes.

 
 
 
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