TY - JOUR
AU1 - Shahriad Ripon, Sayef
AU2 - Hasan Khan, Akhlaque
AU3 - Kumar Bakshi, Samir
AU4 - ., Tareq
AU5 - Chandra Das, Kshitish
AU6 - Kamal Parvez, Mostafa
AU7 - 
AB - 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. Keywords: Process Validation; Protocol; CGMP; BMR; BPR Introduction control, quality attributes, acceptance criteria, change control, documentation to be carried out during Process Validation study of Process (Prospective) validation aims to gain full understand- Granules for Oral Administration. ing of the manufacturing process on the production equipment expected to be routinely used. This is achieved by establishing pa- Product details rameters to be used to operate within a state of control. Once the validation of process is completed, a Batch Manufacturing Record Product Name, Generic Name, Dosage Form, Product Category, (BMR) to 
TI - Process Validation Protocol of Granules for Oral Administration
JF - Acta Scientific Pharmaceutical Sciences
DO - 10.31080/asps.2019.03.0441
DA - 2019-11-19
UR - https://www.deepdyve.com/lp/unpaywall/process-validation-protocol-of-granules-for-oral-administration-4IpQUmDs7O
DP - DeepDyve
ER -