For multiple strengths, one well-designed bioequivalence study is often sufficient for both the UK and EU, provided the remaining strengths qualify for a biowaiver. The number of BE studies is determined by formulation proportionality, pharmacokinetic linearity, manufacturing process and comparative dissolution—not merely by the number of strengths. For immediate-release tablets or capsules, the BE study…
It’s because of physics, chemistry and history. These chromophores have strong UV absorption around 254 nm due to π → π* transitions. Besides: Classical TLC plates often contained fluorescein, that fluoresced at 254 nm (“F254” plates). Compounds that absorbed at 254 nm appeared as dark spots on a fluorescein plate. And since TLC chemists almost…
Content Uniformity (CU) is one of the most critical quality attributes for solid oral dosage forms, particularly for low-dose and high-potency products. However, misunderstanding still exists between Conventional CU and Stratified CU, especially during failure investigations. 1. Conventional Content Uniformity evaluates batch compliance Conventional CU is a pharmacopeial requirement performed as per USP <905> or…
Computerized System Validation (CSV) is the process of ensuring that a computerized system used in a GxP environment performs accurately, consistently, and reliably according to its intended purpose. Reference: FDA — General Principles of Software Validation (GPSV) CSV ensures that systems support product quality, patient safety, and data integrity, and that all electronic records and…
1. Introduction 2. Historical Context and Regulatory Push 3. Understanding the Three Pillars 3.1 Quality by Design (QbD) – The Framework Key Concepts: Stages of Application: Early development → Technology transfer → Lifecycle management. Regulatory Basis: ICH Q8(R2), Q9, Q10, Q11, Q12, Q13, Q14. Tools: Risk assessments (FMEA, Ishikawa, Fault Tree Analysis), control strategy design….
Concepts Link: CMAs of the API directly affect CQAs of the injectable product. Key CMAs of API for Injectables Key CQAs of Injectable Products CMA → CQA Link Example – Corticosteroid Depot Injection Takeaway Read also: Resource Person: Moinuddin Syed. Ph.D, PMP®
