Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Quality by Design


Affiliations
1 College of Pharmacy (D. Pharm), Degaon, Satara (MH)-415 004, India
     

   Subscribe/Renew Journal


Quality by design (QbD) is an essential part of the modern advance to pharmaceutical quality. QbD is best key to build a quality in all pharmaceutical products. Under this concepts of Be throughout design and growth of product, it is important to identify desire product performance report [Target product profile (TPP), Quality Target product profile (QTPP)] and identify critical quality attributes (CQA). To recognize the impact of raw material [critical material attributes (CAM)], critical process parameters (CPP) on the CQAs and identification and control sources of changeability. The plan of pharmaceutical development is to design a quality products and its manufacturing process always deliver the future performance of the product. The base of Quality by design is ICH Guidelines Q8 for Pharmaceutical for development, Q9 quality risk management, Q10 for pharmaceutical quality systems.

Keywords

QBD-Quality by Design.
Subscription Login to verify subscription
User
Notifications
Font Size


Abstract Views: 43

PDF Views: 2




  • Quality by Design

Abstract Views: 43  |  PDF Views: 2

Authors

Sushila D. Chavan
College of Pharmacy (D. Pharm), Degaon, Satara (MH)-415 004, India
Nayana V. Pimpodkar
College of Pharmacy (D. Pharm), Degaon, Satara (MH)-415 004, India
Amruta S. Kadam
College of Pharmacy (D. Pharm), Degaon, Satara (MH)-415 004, India
Puja S. Gaikwad
College of Pharmacy (D. Pharm), Degaon, Satara (MH)-415 004, India

Abstract


Quality by design (QbD) is an essential part of the modern advance to pharmaceutical quality. QbD is best key to build a quality in all pharmaceutical products. Under this concepts of Be throughout design and growth of product, it is important to identify desire product performance report [Target product profile (TPP), Quality Target product profile (QTPP)] and identify critical quality attributes (CQA). To recognize the impact of raw material [critical material attributes (CAM)], critical process parameters (CPP) on the CQAs and identification and control sources of changeability. The plan of pharmaceutical development is to design a quality products and its manufacturing process always deliver the future performance of the product. The base of Quality by design is ICH Guidelines Q8 for Pharmaceutical for development, Q9 quality risk management, Q10 for pharmaceutical quality systems.

Keywords


QBD-Quality by Design.