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OEL and OEB in Pharmaceutical Industry
In pharmaceutical manufacturing, safeguarding worker safety is paramount when dealing with active pharmaceutical ingredients (APIs) and potent substances. Two crucial ...
Intrinsic Dissolution
In this chapter, we delve into the process of determining the intrinsic dissolution rate, a crucial factor in the characterization ...
Certificate of Analysis (COA)
A Certificate of Analysis (COA) is a document that certifies the quality and purity of a product or material. In ...
Quality by Design (QbD)
Quality by Design (QbD) is a systematic approach to pharmaceutical development and manufacturing that emphasizes designing quality into a product ...
Content Uniformity (CU)
Content Uniformity ensures that the active pharmaceutical ingredient (API) is evenly distributed in each finished dosage unit, such as a ...
Blend Uniformity (BU)
Blend Uniformity focuses on the homogeneity of the API in the powder blend before it is compressed or encapsulated. Purpose ...
Difference Between Blend Uniformity (BU) and Content Uniformity (CU)
Stage of Testing Purpose Testing Process Impact of Failure Why Both Matter? Related Topics: OOE OOS OOT Bioavailability Biotechnology Bioinformatics
Calibration
Calibration is a process that demonstrates a particular instrument or device produces results within specified limits, as compared to those ...
Qualification in Pharma
In simple terms, qualification ensures that equipment, systems, and facilities are installed and operate as intended. It’s all about proving ...
Fishbone Diagram in Pharmaceutical Industry
A fishbone diagram is one of the most widely used tools in quality management and is considered one of the ...
Change Control Handling
Change control is a process used in the pharmaceutical industry to manage and document changes to products, processes, or systems. ...
Quality Plan
A Quality Plan is a roadmap that defines how to ensure the quality of a product, service, or project. It ...