Author(s): Kotta Kranthi Kumar

Email(s): kranthikumarkotta@gmail.com

DOI: 10.5958/2321-5844.2019.00007.4   

Address: Dr. Kotta Kranthi Kumar*
Department of Pharmaceutics, SKU College of Pharmacutical Sciences, S. K. University Anantapuramu, Andhra Pradesh, India.
*Corresponding Author

Published In:   Volume - 10,      Issue - 1,     Year - 2019


ABSTRACT:
Quality plays a major role in the pharmaceutical product development and approval. Various official procedures are required for product development. Critical quality plays a major role in the biopharmaceutical consideration. Critical quality attributes plays a major role in the process validation. Critical Quality Attributes (CQA) are chemical, physical, biological and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits. During this stage acceptable limit, baselines, and data collection and measurement protocols should be established. Data from the design process and data collected during production should be kept by the manufacturer and used to evaluated product quality and process control. The product quality issue arises, historical data would be essential in identifying the sources of errors and implementing corrective measures.


Cite this article:
Kotta Kranthi Kumar. Importance of Critical Quality Attributes in Biopharmaceuticals Development. Research J. Topical and Cosmetic Sci.10(1):29-33. doi: 10.5958/2321-5844.2019.00007.4


Recomonded Articles:

Author(s): Harsha Solanki, Vinay Sagar Verma, Mukesh Sharma, Ajay Singh, Garima Sharma, ManishaMajumdar, Sujata Gupta, Sandhya, Vandana Sahu, Kalyani Dewangan, D.K. Tripathi, Amit Alexander, Ajazuddin

DOI: 10.5958/2321-5844.2016.00007.8         Access: Open Access Read More

Author(s): Gite Shital S., Jadhav Aishwarya J., Zalte Amar G., Saudagar Ravindra B.

DOI:         Access: Open Access Read More

Author(s): Priya R. Kawarkhe, Subhash V. Deshmane, Kailash R. Biyani

DOI:         Access: Open Access Read More

Author(s): Abhijit Ray

DOI:         Access: Open Access Read More

Author(s): Mukund Nagarnaik, Arun Sarjoshi, D.G. Kshirsagar, Pranjali Linge, Shital Bhore , Zeba Qureshi, Girish Pandya

DOI:         Access: Open Access Read More

Author(s): Beedha. Saraswathi, SK. Shabana, D. Ramya Sri, D. Anantha Lakshmi, M. Shivaji, T. Satyanarayana

DOI: 10.5958/2321-5844.2017.00006.1         Access: Open Access Read More

Author(s): Ghurghure S M, Dhange A A, Kamalapure N R, Kate S N, Katkar A R, Katta A V, Kattimani C U, Kattimani S G

DOI: 10.5958/2321-5844.2019.00001.3         Access: Closed Access Read More

Author(s): Sankalp Goswami, Prachi Sharma, Yogesh Shivhare

DOI:         Access: Open Access Read More

Author(s): Saikrishna Reddy, Akshaya Reddy, Pranitha, Sravani, Kvm Krishna, A. Ramesh

DOI: 10.5958/2321-5844.2016.00004.2         Access: Open Access Read More

Author(s): A. Santosh Kumar, P. Kavya Deepika, D. Nagasen, D.V. Dakshina Murthy,V. Sai Kishore

DOI:         Access: Open Access Read More

Author(s): Rabindra K Nanda, Amol A Kulkarni, Meenal N Ranjane , Poonam N. Ranjane

DOI:         Access: Open Access Read More

Author(s): Singh Shikha Y., Aher Smita S., Saudagar Ravindra B.

DOI:         Access: Open Access Read More

Author(s): Harshal Patil, Jyotsna Waghmare

DOI:         Access: Open Access Read More

Author(s): Rashmi Tamanekar, Shamika Salavkar, Rajani Athawale

DOI:         Access: Open Access Read More

Author(s): Archana Gorle, Swati Patil

DOI: 10.5958/2321-5844.2018.00008.0         Access: Closed Access Read More

Author(s): Debarshi Datta, Subhashis Debnath, Sirisha P., Nagasree T., Swetha D., M. Niranjan Babu

DOI:         Access: Open Access Read More

Author(s): Karan Shirsat, Prasad P. Dahivelkar, Avinash S. Dhake

DOI:         Access: Open Access Read More

Research Journal of Topical and Cosmetic Sciences (RJTCS) is an international, peer-reviewed journal, correspondence in the fields of skin and cosmetic research....... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2321-5844 


Recent Articles




Tags