This paper is published in Volume-7, Issue-3, 2021
Area
Pharmaceutical Science
Author
Prateek Goyal, Dr. Vishal Gupta
Org/Univ
Mansarovar Global University, Bhopal, Madhya Pradesh, India
Keywords
Product life cycle, Quality evaluation, cGMP, EU, USFDA, Pharmaceutical quality system, Quality Target product profile, Critical material attributes, Critical quality attributes, Critical process parameters, Quality Risk Management, Design space, Control Strategy, Life cycle Management and Continuous improvement.
Citations
IEEE
Prateek Goyal, Dr. Vishal Gupta. Quality Life Cycle of the Pharmaceutical Products, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.
APA
Prateek Goyal, Dr. Vishal Gupta (2021). Quality Life Cycle of the Pharmaceutical Products. International Journal of Advance Research, Ideas and Innovations in Technology, 7(3) www.IJARIIT.com.
MLA
Prateek Goyal, Dr. Vishal Gupta. "Quality Life Cycle of the Pharmaceutical Products." International Journal of Advance Research, Ideas and Innovations in Technology 7.3 (2021). www.IJARIIT.com.
Prateek Goyal, Dr. Vishal Gupta. Quality Life Cycle of the Pharmaceutical Products, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.
APA
Prateek Goyal, Dr. Vishal Gupta (2021). Quality Life Cycle of the Pharmaceutical Products. International Journal of Advance Research, Ideas and Innovations in Technology, 7(3) www.IJARIIT.com.
MLA
Prateek Goyal, Dr. Vishal Gupta. "Quality Life Cycle of the Pharmaceutical Products." International Journal of Advance Research, Ideas and Innovations in Technology 7.3 (2021). www.IJARIIT.com.
Abstract
Quality in the pharmaceutical industry is a very important. Quality cannot be tested into the products. But building-in quality from the development phase and throughout a product’s life cycle will deliver a perfect quality product. Quality is the most vital aspect of medicines and any short fall may generate risks to the patient. It is anticipated that adequate training of pharma professional and practicing the validated controls will deliver quality product. However, this should not be the one-time event but an activity that continues throughout a product’s life. The consistency in quality parameters shall be evaluated considering all three manufacturing stages simultaneously, including the Key Starting Material (KSM), Active Pharmaceutical Ingredient (API) and Pharmaceutical Finished Pharmaceutical Product (FPP).