Typical Process flow of Generic Drug Development

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– Obtain project proposal from project management department
– Perform literature review and request to the TSD/SCM for RLD/ Reference/ Market sample
– Raise requisition for new API, excipients, packaging materials and analytical requirements to TSD/SCM
– Perform RLD/ Reference/ Market sample characterization
– Identify QTPP and CQA
– Perform Preformulation Study and compile information
– Collect, Review and study the DMF (if available)
– Select Tooling
– Design a prototype formulation
– Perform Drug excipient compatibility study (if required)
– Identify the lead formulation
– Perform stress study (if required)
– Initiate preliminary method development activities
– Manufacture three laboratory batches on the lead formulation
– Select packaging components and submit sample to the packaging department and PMD for evaluation
– Initiate stability study
– Order RMs for PO batch(es) (if required)
– Prepare the recipe for submission/regulatory approval
– Raise CCR and conduct the risk assessment to manufacture PO batch(es)
– Initiate discussion for cleaning validation
– Prepare and obtain approval of process optimization protocol and BMR (if required)
– Manufacture the process optimization batch(es) (if required)
– Submit sample for packaging trial
– Initiate Method Validation activities
– Review stability data and declare shelf life of the product
– Prepare and submit the annexure
– Request PMD/RA to obtain approval for inclusion materials and price from regulatory authority
– Request MMIC to raise the requisition for RMs and PMs for PV batch(es)
– Raise CCR and conduct the risk assessment (if required)
– Prepare and obtain approval of protocol for process and packaging validation batch
– Provide approved BMR and BPR to Production
– Conduct pre-validation meeting and establish roles & responsibility
– Manufacture the process validation batch(es)
– Prepare product development report (PDR) of the drug product

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