Quality systems and risk management
A quality system connects manufacture, control, change management and investigations. Addressing a deviation involves understanding its cause and checking the action’s effectiveness.
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Sterile manufacture and contamination control
Contamination prevention combines facility and process design, operating procedures and monitoring. Annex 1 states that monitoring or testing alone cannot assure sterility.
Cleaning validation and exposure limits
Annex 15 links residue carryover limits to a toxicological evaluation and documented rationale. A generic calculator cannot establish a substance-specific PDE.
Process validation and knowledge transfer
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.
Analytical procedures and OOS investigations
Q14 addresses analytical development and maintenance; Q2(R2) addresses validation. An OOS result needs scientific investigation; unjustified retesting does not resolve the original result.
Stability and shelf life
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 and electronic records
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.
Bioequivalence and the scope of M13A
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.
Registration dossiers and deficiency responses
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.
Pharmacovigilance and signal management
GVP separates pharmacovigilance processes into modules. Module III inspection revision 2 is effective from 10 September 2026. EMA requires interim application of E2D(R1) and M14 guidance and definitions insofar as they affect GVP, with the EU implementation strategy for E2D(R1).
Medicine information and pharmacy practice
DailyMed displays submitted, in-use labelling, which may differ from the latest FDA-approved label. Database inclusion alone does not establish approval.
Distribution and the cold chain
Good distribution practice supports medicine quality through the supply chain. Connecting shipment identity, transport conditions and handling records supports deviation assessment.
Medical device safety and performance evidence
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.
Research appraisal and reporting
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.
Biosimilar medicines
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.
Health technology assessment and access
HTA considers medical, economic, social and ethical information. Interpreting value requires a suitable comparator and local context, distinguishing clinical evidence from cost assumptions.