ROOT CAUSE ANALYSIS, WHERE QUALITY GROWS UP A strong Root Cause Analysis converts confusion into cause–and–effect clarity: 1) It separates symptoms from sources2) It turns firefighting into learning3) It transforms compliance into confidence HUMAN ERROR ≠ ROOT CAUSE Human actions are effects of system design & not the source of failure. Ask deeper questions:1) Was…
Aluminum Foil: Aluminum foil offers the highest barrier overall, against both moisture and oxygen, completely blocking light and gases. Aluminum foil used for highly sensitive drugs due to its exceptional impermeability. Ethylene Vinyl Alcohol (EVOH): oxygen barrier properties, particularly in dry conditions,but is moisture sensitive and often used in multilayer films with hydrophobic outer layers…
To most organizations, CAPA metrics are about compliance i.e., meeting timelines, closing investigations, passing audits. To regulators, they are a window into your quality culture i.e., how we think, learn & respond to risk. ILLUSION OF 100% ON-TIME SUCCESS Many companies proudly report: 1) 98% CAPAs closed on time2) 100% effectiveness checks completed3) Zero overdue…
Scaling up from the lab bench to commercial manufacturing is one of the most critical steps in pharmaceutical development. It is not just about making a bigger batch but it is about proving consistency, ensuring quality, and meeting regulatory expectations. Below a simple checklist that often guides scale-up and exhibit batch execution: Pre-Scale Up: finalize…
Surfactants play a key role in improving solubility and maintaining sink conditions, but using too much can artificially speed up drug release. If you get similar dissolution results across different concentrations, it’s best to go with the lowest level that is still physiologically relevant. Reproducibility matters – choose a concentration that gives consistent results across…
One of the areas of the most focus in the dissolution world right now is the Apex vessel, which was formerly called the Peak vessel. With all of this new attention, I thought it would be good to answer some of the most common customers I get from scientists about this unique vessel. When should…
In the development of generic pharmaceutical products, aligning formulation design and regulatory strategy with prior approved data significantly improves the chances of first-time-right submissions. One highly effective method to gain such insight is through the use of biopharmaceutical review documents obtained via FOI requests. These documents, available publicly through regulatory agencies such as the USFDA…
Affinity Chromatography is one of the most powerful and precise techniques for the analysis and separation of biomolecules such as proteins, enzymes, and antibodies. Due to its high specificity and ability to isolate specific compounds from complex mixtures, it is highly popular in pharmaceutical industries, biotechnology, and biological research. Principle of Affinity Chromatography In this…
