Start the case
Three vials arrive in one shipment. Two supplier certificates and an external laboratory report are on file. Decide which documents can be linked to each vial, compare each reported result with its own criterion and record what would resolve an open question.
- Fictional case documentsReceiving log, three vial labels, two supplier certificates and one external laboratory report.Case documents PDF
- Student worksheetFour tasks with spaces for evidence, calculations and a decision note.Worksheet PDF
- Worked solution and teaching notesAnswer key, model decisions and a 12-point marking guide.Solution PDF
Learning objectives
- Use a material identifier and supplier lot to match a vial to a certificate of analysis.
- Compare reported intact mass, relative peak area and content with the appropriate criteria and units.
- Identify the missing record for an external sample and write a decision that reflects the documented scope.
Use a browser or the printable PDFs. Basic decimal comparison and familiarity with a lot number are sufficient. Instructors can distribute the case documents and worksheet together and share the solution after the exercise.
Provenance and reuse
The organizations, records, analytical results and limits are fictional. The example illustrates classroom document review. FDA / ICH Q7, section 11.4 informed the selection of certificate fields.
Available under Creative Commons Attribution 4.0 International. The reuse notice gives the attribution. All essential information is available as text, including the vial labels and evidence tables.