Quality by Design has become a central expectation in pharmaceutical development, even though it is not legally mandatory in either the EU or the UK. Both EMA and MHRA align fully with ICH Q8(R2), Q9(R1), Q10, Q11, and Q12, and expect a clear demonstration of product and process understanding for every new or complex formulation….
The Common Technical Document (CTD) is one of the most significant harmonisation achievements in global regulatory science. Before CTD, every country required dossiers in different formats, leading to duplication, rework and delays in approvals. With the adoption of CTD, a single, harmonised structure now guides how quality, clinical and non-clinical data are organised for submission…
ONEFormulation development should always begin with understanding the drug substance. Before selecting any excipient, the scientist must know whether the API is soluble or insoluble, acidic or basic, hygroscopic or stable, and whether the dose is low or high. TWOThe reference product should be studied in detail. Its dosage form, strength, release behavior, labeling claims,…
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…
