Chief Pharmacist
Reactive Impurities in Pharmaceutical Excipients
Reactive impurities in pharmaceutical excipients are often overlooked, yet they can have a serious impact on drug product stability and ...
API Impurity Specification
In making medicines, setting impurity limits for the Active Pharmaceutical Ingredient (API) is a key step to ensure quality and ...
Pharmacomicrobiomics
It is the study of how intra- and inter-individual differences in the bacteria associated with us especially gut bacteria (aka ...
Lean Six Sigma and QbD
Quality by Design (QbD) is a science- and risk-based approach outlined in ICH Q8, Q9, and Q10. It emphasizes that ...
Relationship Between QTPP and CQA
Introduction In QbD) the development of a pharmaceutical product starts with understanding the patient and therapeutic needs. These needs are ...
Quality Target Product Profile (QTPP) in Pharmaceutical Development
The Quality Target Product Profile (QTPP) is a prospective summary of the key quality characteristics that a drug product should ...
Lean Six Sigma in Pharmaceutical Formulation Development – A Practical Perspective
In today’s competitive pharmaceutical environment, cost optimization, regulatory compliance, and speed to market are critical success factors. While Quality by ...
Isolators in Pharma Industry
Isolators are sealed enclosures that maintain a Grade A (ISO 5) environment using HEPA filtration and unidirectional airflow. Operators manipulate ...
Disinfection vs. Sterilization
In pharmaceutical and healthcare settings, preventing microbial contamination is essential. However, disinfection and sterilization are not the same—misusing these terms ...
Stability Study in Pharma
Stability Testing This is a critical process in evaluating the quality and shelf life of pharmaceutical products. Types of Stability ...
Dimethyl Carbonate (DMC)
Dimethyl Carbonate (DMC) is a colorless, flammable liquid with a mild, pleasant odor. It’s a versatile organic compound used as ...
Citric Acid Anhydrous Vs Monohydrate
Citric acid is available in two main forms: anhydrous and monohydrate. The key differences between them are: Chemical Composition : ...