Flow Charts

AMT : It is the Documented process that qualifies a laboratory (receiving laboratory) to use an analytical method that originated in another laboratory (transferring laboratory), whether that is internal or external to the receiving laboratory. FC-AMTDownload For any feedback...

Patent is defined as a statutory privilege granted by the government to inventors, and to other persons deriving their rights from the inventor, for fixed years, to exclude other persons from manufacturing, using or selling...

Vendor is an  individual  or  company  that  sells  goods  or services  to someone  else  in  the  economic production  chain. An audit  is a  independent, systematic and documented process  for obtaining  audit evidence  and  evaluating...

Validation lifecycle approach is linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.  FC-Validation LifecycleDownload

Impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, that arise out of synthesis or unwanted chemicals that remains with APIs. According to the ICH, impurities...

The Annual Product Quality review (APQR) is an effective quality improvement tool to enhance the consistency of the process and the overall quality of the product. APQR will capture a broader view of product...

Root cause analysis (RCA) is a systematic process for identifying “root causes” of problems or events and an approach for responding to them. Root cause analysis is defined as a collective term that describes a wide...

Lean principles and Six Sigma methodologies are combined within a modified approach based on the main concept of DMAIC (Define, Measure, Analyze, Improve, Control ) structure that successfully used to improve several processes. FC-Modified ApproachDownload For...