Knowledge & training
Choose a field, prepare the evidence, then use the relevant tool. These pathways organise a review; applicability depends on the product and competent authority.
Source and content review date:No matching pathway. Try another term or open the resource directory.
Connect process monitoring, investigations, corrective action and change management to management review throughout the product lifecycle.
An action plan with owners, due dates and effectiveness evidence; the number of closed actions alone does not demonstrate system quality.
A contamination control strategy connects facility design, people, materials, processes and monitoring; final testing cannot compensate for inadequate process control.
A documented strategy linking each risk to a barrier, evidence and review; avoid reducing it to one compliance percentage.
Start with a documented laboratory investigation and extend to manufacturing when appropriate. Do not invalidate a result without documented scientific justification or test into compliance.
A report documenting cause, impact scope, any retest rationale and an independent quality decision.
Data should remain complete, consistent and accurate, with context and metadata preserved. Shared accounts and untraceable records weaken attribution.
A risk-based plan connecting records to their origin, permissions, review and retention period.
Identify the market, product and container system before choosing a stability programme. Do not assign one climatic condition to every product or Arab market.
A protocol specifying batches, time points, tests and criteria, with shelf life justified by the data.
Start with guideline scope, dosage form, market and comparator. A study or waiver needs a product-specific rationale; a waiver is not an automatic conclusion.
A strategy memo linking each option to evidence and questions requiring resolution with the competent authority.
Comparability draws on an integrated package of quality, functional, safety and efficacy evidence appropriate to the product. A draft or news item about streamlined development is not an approved waiver.
A development plan justifying proposed studies and documenting the status of references used for each market.
Intended purpose, user and device characteristics determine the starting point for classification. The global framework informs regulation; it is not one authorisation for every country.
A dossier map connecting requirements, evidence, gaps and post-market follow-up.
Connect storage and transport to supplier qualification, traceability and deviations. Extra stock alone does not resolve quality or cold-chain weaknesses.
A continuity plan separating demand assumptions from evidence of supplier quality and transport capability.
The Common Technical Document has five modules: Module 1 is regional and Modules 2–5 share a common structure. A common structure does not make national requirements identical.
A dossier matrix recording requirements, evidence, versions, owners and gaps before submission.
Distinguish suspicion from confirmation and follow approved quarantine, escalation and reporting procedures. Appearance or a package photograph alone cannot establish authenticity.
A documented incident file distinguishing facts from unresolved points and identifying the competent-authority reporting route.
The lifecycle approach covers process design, qualification and continued performance verification. Successful initial batches do not remove the need to monitor commercial performance.
A plan connecting acceptance criteria, analysis and trends to decisions and reassessment.
Reference watch
The European Commission published revised Annex 19 on 24 June 2026, with application from 24 September 2026. When preparing sample procedures for the European market, check the revised text and its scope for your product.
Suggested office action: compare the current sampling procedure with the text and record gaps and action owners before approving a change.
Commission announcement and official textCheck document scope, status, implementation date and market requirements. Drafts, final documents and news releases have different standing. These editorial checklists are informed by references; they are not regulator-issued text.
