Abstract

OPTIMIZATION AND VALIDATION PROCESS FOR FORMULATION AND COATING OF TABLET X

Nisha Thakur*, Shweta Aggrawal, Anita Rani, Virendra Yadav

ABSTRACT

The process validation study of X tablets has been carried out on two consecutive batches (Batch 1and Batch 2) as per process validation protocol. Batches have been manufactured and compiled as per batch manufacturing record. The starting materials used in manufacturing of validation batches has been procured from approved vendors and were analyzed by QC department and approved by QA department. The critical process parameters of manufacturing process have been evaluated with respect to quality attributes of drug product and found to be well within the predefined acceptance criteria. Sampling at various stages of validation batches was carried out as per established sampling plan as mentioned in protocol. All two validation batches comply with the release specifications of drug product and meet the quality attributes of the product. The percentage yields of all three validation batches at various manufacturing stages have been mentioned in relevant section of this report. The observations limits for percentage yield at various stages of manufacturing process of X tablets have been finalized as follows Lubrication 98.0%, Compression 98.0 %, Film coating 98.0%, Inspection 98.0%.

Keywords: Validation, QA, QC.