A – ANDA (Abbreviated New Drug Application) – The golden ticket to launch a generic drug in the US—only if bioequivalence proves it’s not an imposter.
B – Bioequivalence Study – Where a generic drug proves it matches the innovator’s absorption. No match? No market entry.
C – cGMP (Current Good Manufacturing Practices) – The rulebook ensuring drugs are made right every time. Ignore it, and expect warning letters.
D – DMF (Drug Master File) – A confidential dossier on drug substance manufacturing. A regulatory vault, accessible via a Letter of Authorization.
E – Exhibit Batches – The test batches proving consistency before filing.
F – FDA (Food and Drug Administration) – The regulatory giant that decides if a drug lives or dies in the US market.
G – GDUFA (Generic Drug User Fee Act) – Pay this fee, and FDA will review your ANDA.
H – Health Authority Queries – Questions from regulators that can range from insightful to absurd. Answer wisely or expect delays.
I – ICH Guidelines (International Council for Harmonisation) – The global rulebook for quality, safety, and efficacy in drug development.
J – Justification Report – The official explanation for deviations or unexpected process changes.
K – KSM (Key Starting Material) – The critical ingredient in drug substance synthesis.
L – LOA (Letter of Authorization) – The permission slip allowing an applicant to refer to a DMF without revealing trade secrets.
M – Method Validation – The rigorous testing that proves an analytical method is accurate and reliable.
N – NDA (New Drug Application) – The submission for brand-new drugs.
O – OOS (Out of Specification) – Test results outside set limits. The trigger for investigations, re-tests, and sleepless nights.
P – Process Validation – The proof that a manufacturing process consistently produces quality products. One-time success doesn’t count.
Q – Quality by Design (QbD) – A proactive approach ensuring quality is built into a product, not just tested at the end.
R – Risk Assessment – Identifying and controlling potential failures before they become regulatory disasters.
S – Stability Study – Testing how a drug holds up over time, determining its shelf-life and storage conditions.
T – Type II DMF – The most common DMF, covering drug substance details.
U – USP (United States Pharmacopeia) – The US standard for drug quality.
V – Variation Filing – The regulatory process of updating authorities about post-approval changes.
W – Warning Letter – FDA’s way of saying, “Fix your GMP issues or face serious trouble.”
X – X-ray Diffraction Study – A powerful technique to analyze crystalline structures in drug substances, ensuring consistency in polymorphs.
Y – Yield Calculation – The math behind how much drug is obtained from raw materials, critical for cost and efficiency.
Z – Zero Tolerance Policy – Regulators’ stance on critical non-compliance. No second chances, just consequences.
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Resource Person: VENKATA RAMA SIVA KUMAR RACHAKONDA