For skill enhancement and skill development as well as motivation of staff, Accuprec Research Pvt. Ltd. has started Accupulse lecture series. Last week expert for the series was Dr. M.C. Gohel, who has recently joined in Board of Advisors of the CRO. He gave training on Quality By Design (QBD) & Design of Experiment (DoE) to staff.
Dr. Mukesh C. Gohel is working as a Professor and PG Director at Anand Pharmacy College, Anand, Gujarat since 2014. He served as a Principal and Professor at L. M. College of Pharmacy (LMCP), Ahmedabad. Dr. Gohel has published 186 full-length research papers in reputed journals. He has provided training in the area of Design of Experiments (DoE) and Quality by Design (QbD) in many leading pharmaceutical companies of India. He is recipient of The IPA HCG Scitech Innovation Award in solid dosage form development for the year 2016. He has received best research paper award from IDMAand IPA.
Design of experiments (DOE) is a systematic method to determine the relationship between factors affecting a process and the output of that process. In other words, it is used to find cause-and-effect relationships. This information is needed to manage process inputs in order to optimize the output, Dr. Gohel said. He gave detail about DoE and Lean Six Sigma Quality Management and expalined how the tools can be helpful in Pharma sector.
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance. QbD methodology helps in identifying and justifying target product profiles, product and process understanding. It helps in continuous improvement, he added.