Market Surveillance and Control
What the exam tests
This is the post-market enforcement domain: sampling, testing, defect classification, recall and action against falsified and substandard medicines. Questions ask you to classify a defect and choose the proportionate action.
The surveillance loop
Risk-based sampling from manufacturers, importers, wholesalers and pharmacies → testing at a drug testing laboratory → result review → classification → enforcement. Enforcement ranges from warning and product withdrawal to recall, seizure, licence suspension and prosecution. Advertising is also controlled: prescription-only products may not be advertised to the public.
Defect classification
- Substandard: fails specification - assay, dissolution, uniformity, sterility, labelling.
- Falsified: deliberate misrepresentation of identity, composition or source.
- Spurious or unregistered: no registration, forged documentation, imitation packaging.
- Contaminated: foreign matter or microbial contamination.
Recall classes
Class I: reasonable probability of serious harm or death - act immediately, nationwide. Class II: temporary or reversible harm. Class III: unlikely to cause harm but breaches regulation. A recall needs distribution records, retrieval, quantity reconciliation and a final report.
Worked example
An injectable fails sterility while a parallel sample of the same batch is still on shelves. Sterility failure in a parenteral is a Class I defect: immediate quarantine and recall of all batches in distribution, notification of the authority, tracing to hospital level, and investigation of the sterilisation cycle and media fills.
Traps
Calling a dissolution failure minor because assay passed; recalling only from the wholesaler and not the pharmacy shelf; omitting quantity reconciliation; confusing a market withdrawal (commercial) with a safety recall; ignoring advertising rules when a product is classed OTC.