Explain The Strategy For Industrial Process Validation Of Solid Dosag

1.	Explain The Strategy For Industrial Process Validation Of Solid Dosage Forms?
Answer» The use of different lots of raw materials should be included. i.e., active DRUG substance and major excipients. Batches should be run in succession and on different days and shifts (the latter CONDITION, if APPROPRIATE). Batches should be manufactured in the equipment and facilities designated for EVENTUAL commercial production. Critical PROCESS variables should be set within their operating ranges and should not exceed their upper and lower control limits during process operation. Output responses should be well within finished product specifications. Failure to meet the requirements of the Validation protocol with respect to process input and output control should be subjected to process requalification.

Explain The Strategy For Industrial Process Validation Of Solid Dosage Forms?

Answer»

The use of different lots of raw materials should be included. i.e., active DRUG substance and major excipients.
Batches should be run in succession and on different days and shifts (the latter CONDITION, if APPROPRIATE).
Batches should be manufactured in the equipment and facilities designated for EVENTUAL commercial production.
Critical PROCESS variables should be set within their operating ranges and should not exceed their upper and lower control limits during process operation. Output responses should be well within finished product specifications.
Failure to meet the requirements of the Validation protocol with respect to process input and output control should be subjected to process requalification.