In liquid oral dosage form development, solubility is one of the most critical factors to assess during preformulation studies. The solubility of the active pharmaceutical ingredient (API) directly impacts its bioavailability — how effectively the body absorbs the drug. Without adequate solubility, the drug may not dissolve sufficiently to exert its therapeutic effect, leading to…
A recent FDA Warning Letter (10 March 2026) to Simtra BioPharma Solutions highlights a pattern the industry keeps seeing in sterile manufacturing. Not one failure but a chain of small ones. The result: FDA concluded the site could not reliably assure sterility. The lesson is simple. When these drift apart, regulators eventually connect the dots….
Bioequivalence studies are fundamental in ensuring that generic drugs are as effective and safe as their brand-name counterparts. These studies compare the rate and extent of drug absorption in the body to demonstrate that a generic formulation behaves similarly to the reference product. But what defines a “passing” bioequivalence study? Let’s break it down: Bioequivalence…
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…
