QbD
Developing an Effective Control Strategy within a QbD Framework
Quality by Design is not about documentation. It is about understanding how materials and processes influence product quality and patient safety. The pharmaceutical control strategy develops step by step, as outlined below: I. Identification of Critical Material Attributes (CMAs) CMAs are physical or functional properties of raw materials that can ... Read More
Drug Excipient Compatibility Study During QbD
To perform Drug-Excipient Compatbility (DEC) study 4 types of samples are required to be preprared: All these samples are packed in flint glass vial or amber color vial (if API is light sensitive) with and without sealing & exposed for a particular time period i.e. 1 Day, 3 Days, 7 ... Read More
Pharmaceutical Quality by Design Tools
Prior Knowledge Knowledge may be defined as a familiarity with someone or something, which can include information, facts, descriptions, and/or skills acquired through experience or education. The word “prior” in the term “prior knowledge” not only means “previous,” but also associates with ownership and confidentiality, not available to the public. ... Read More
Difference Between QbD and DoE
Quality by Design (QbD) vs Design of Experiments (DoE) (concepts comparison) Definition: Focus: Application: Approach: Read also: Resource Person: Atefe Nasrollahi
Quality by Design (QbD) in Pharmaceutical Development
Quality by design (QbD) is a scientific and risk-based approach to pharmaceutical product development that begins with predefined objectives. Instead of relying on finished product testing alone, QbD ensure the product quality throughout the development process. Objective of QbD Approach Elements of QbD QbD comprises different elements of pharmaceutical development ... Read More