Quality by Design in Parenteral Formulation: ...

Quality by Design in Parenteral Formulation: A Review

Author Name : Mrs. Reshma Mirajkar, Nikhil Patil, Sanket Basate

ABSTRACT

Quality by Design is the modern approach for the quality of pharmaceuticals. The application of quality by design pharmaceuticalsproduct development is currently a thrust area for theauthorities and the pharmaceutical production. The goal of the pharmaceutical parenteral formulation is to delivermedicine to patients in a safe and efficacious manner making certain therapeutic edges. In the future parenteral dosage forms rapid onset action bioavailability and the drugs with a narrow therapeutic index.Under this concept of QbD throughout designing and development of a parenteral product, it is essential to define the desire product performance profile [Quality target product Profile (QTPP)] and identify critical quality attributed (CQA),To recognize the impact of raw material [critical quality attributes (CQA)].It is based on ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical qualitysystems. Parenteral drug products development involves unique challenges and primaryimportanceintermsof the safetyofthepatient's Design of experiments, risk assessment tools, and Control strategyis also discussed for their role in QbD.The pharmaceutical development plan is to design quality of products and manufacturing process always deliver the future performance of the product.

Keywords. Critical quality attribute, Risk assessment. ICH Q9 Guideline, the Failure mode of effect analysis, Quality of target product profile,