Process Validation Protocol of Granules for Oral Administration

Abstract

To ensure that the pharmaceutical product is being produced with its consistent quality standard, process validation is a very effective tool. It establishes documented evidence to ensure a high degree of assurance that specific process will consistently produce a product meeting its predetermined specifications and quality requirements. Process validation is a cGMP requirement for finished products and to standardize the method used in establishing process validation studies, a process validation protocol is developed.Based on the protocol, once the process validation is done, a complete process validation report will be prepared which will aid in preparing a complete BMR and BPR for manufacturing and packaging of pharmaceutical products. Process (Prospective) validation aims to gain full understanding of the manufacturing process on the production equipment expected to be routinely used. This is achieved by establishing parameters to be used to operate within a state of control. Once the validation of process is completed, a Batch Manufacturing Record (BMR) to be finalized to use in routine manufacturing. Any variation mode to this BMR should be made in accordance with change control procedure [1][2][3][4][5].