Process Validation Of Softgelatin Capsule In Pharmaceutical Industry
DOI:
https://doi.org/10.47750/pnr.2023.14.S02.226Abstract
Process validation is the collection of data from the process design stage to commercial production that offers scientific evidence that a process is capable of reliably producing high-quality products.
The validation study for Ibuprofen Capsules 400 mg was conducted by taking into account critical process parameters at various stages of manufacturing process such as Fill preparation, gel preparation, encapsulation, drying, wiping, sorting, and inspection are all included.
The analytical results obtained for three consecutive process validation batches manufactured in accordance with approved BMR/BPR were documented in a controlled manner in accordance with the company's policies.The report is reviewed, conclusions are drawn, and the report is finally signed by the head of the quality department.The validated resultsof the three batchesshow that the manufacturing process of Ibuprofen Capsules 400 mg is capable of delivering quality product and ensuring that the process is under control during routine production.
