Category: Cleaning Validation
-
Hold time study in pharmaceutical manufacturing
Hold time study in pharmaceutical manufacturing. What is hold time study? Good manufacturing guidelines for pharmaceutical manufacturing mentions that a pharmaceutical manufacturing unit must follow time limitations for stages of manufacturing. US FDA guidelines have not provided a particular time as standard for hold time. Definition of hold time: It is a time period for…
-
Hold time study in cleaning validation
Hold time study for clean and unclean equipments must be carried out during cleaning validation. It’s one of important aspect that many pharma companies forget to do Hold time study for clean and unclean equipments during Cleaning Validation. What is Clean equipment hold time dirty equipment hold time ? During validation of cleaning procedures, hold…
-
Cleaning Validation In Pharma
Cleaning validation in pharma manufacturing. When you thinking of doing cleaning validation of an equipment or a procedure adapted for cleaning, first question you should ask is that is the cleaning validation planed in the validation master plan? If not it’s not late to do that. Along with cleaning validation most important work needs to…
Guidelines on Pharmaceutical Manufacturing Pharma Quality Assurance Quality Management System 