Knowledge you can use
Primary-source notes, clear scope and working checklists to organise a pharmaceutical review.
A quality system connects manufacture, control, change management and investigations. Addressing a deviation involves understanding its cause and checking the action’s effectiveness.
Contamination prevention combines facility and process design, operating procedures and monitoring. Annex 1 states that monitoring or testing alone cannot assure sterility.
Annex 15 links residue carryover limits to a toxicological evaluation and documented rationale. A generic calculator cannot establish a substance-specific PDE.
FDA presents validation as a lifecycle: process design, process qualification and continued process verification. A few successful batches do not replace process understanding and monitoring.
Q14 addresses analytical development and maintenance; Q2(R2) addresses validation. An OOS result needs scientific investigation; unjustified retesting does not resolve the original result.
At the check date, EMA lists Q1A(R2) as effective and consolidated Q1 as a Step 2b draft. Distinguish draft proposals from adopted product and market requirements.
Data integrity includes the original record, metadata and context. FDA links audit-trail review to record review and risk, while retaining frequencies specified in applicable requirements.
M13A covers immediate-release oral solid forms delivering drug systemically. In the EU it supersedes specified earlier EMA provisions for non-replicate designs, not all bioequivalence guidance.
CTD has five modules: Module 1 is region-specific and Modules 2–5 share a common organisation. Structure alone does not establish content acceptance or regional eCTD compatibility.
GVP separates pharmacovigilance processes into modules. Module III inspection revision 2 is effective from 10 September 2026. EMA also identifies upcoming updates linked to E2D(R1) and M14.
DailyMed displays submitted, in-use labelling, which may differ from the latest FDA-approved label. Database inclusion alone does not establish approval.
Good distribution practice supports medicine quality through the supply chain. Connecting shipment identity, transport conditions and handling records supports deviation assessment.
IMDRF sets out general safety and performance principles across device and IVD lifecycles. Evidence depends on intended purpose, device and market; one generic list cannot cover every product.
Study registries and appropriate reporting guidelines help track planned and reported work. ClinicalTrials.gov listing does not mean the US government has approved a study’s safety or science.
A biosimilar is highly similar to a reference biological medicine and is not simply a chemical generic. Comparability addresses quality, activity, safety, efficacy and immunogenicity.
HTA considers medical, economic, social and ethical information. Interpreting value requires a suitable comparator and local context, distinguishing clinical evidence from cost assumptions.
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These are concise working guides, not complete courses or replacements for source documents. Open “Coverage and sources” for geographic monitoring evidence and remaining gaps.
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