Deciding what to test on receipt and what to accept on paper: why raw material testing is a risk decision rather than a blanket policy and what identity testing is the irreducible minimum for, where genetic stability testing belongs for a cell or vector product rather than for a chemical, what an analytical service laboratory is for when a test is needed rarely, how product failure analysis and electronic failure analysis differ in method and in what evidence they can deliver, what preventive maintenance of laboratory equipment and oven calibration services contribute to the same assurance, and what a supplier agreement has to contain before any of it can be relied on

Building the programme

1. Test identity on everything. Confirming a container holds what the label says is the irreducible minimum and it catches the errors that matter most. It is usually a fast instrumental check rather than a full analysis.
2. Rank materials by consequence. Which materials, if wrong, would invalidate a study or a batch? Those get performance testing. The rest are accepted on certificate from a qualified supplier, and the ranking is written down.
3. Qualify the supplier rather than every lot. An audited supplier with a stable process and a meaningful certificate reduces the testing burden legitimately. Supplier qualification is the work that makes reduced testing defensible.
4. Use a service laboratory for rare tests. A test needed twice a year does not justify an instrument, a method and a trained analyst. Outsourcing it is cheaper and produces a report from an accredited scope.
5. Investigate failures with the right technique. Failure analysis on a material, a device or an electronic assembly uses different methods and delivers an evidenced opinion. Agree the scope and the techniques before the investigation starts.
6. Keep the supporting systems calibrated. Ovens, balances and thermometers used in incoming testing need their own calibration, and preventive maintenance on the equipment is part of the same assurance chain.

Identity is the cheapest insurance

The failures that cause the most damage are mislabelled or substituted materials, and they are caught by a fast identity check rather than by a full analysis. Every incoming material can afford one.

Choose an instrumental method that takes minutes, build it into receiving, and record it against the lot.

Write the reasoning, not just the result

A programme that tests some materials and not others has to be able to explain why. That explanation, written once as a risk assessment, is what makes reduced testing defensible to an auditor and reviewable when a material changes.

Review it when a supplier, a process or a product changes rather than annually out of habit.

Common questions

Do I have to test every incoming material?

Identity, yes, as a minimum. Full testing of everything is rarely proportionate; a documented risk ranking with supplier qualification is the standard and defensible approach.

When should testing be outsourced?

When a test is needed rarely, requires accreditation, or needs an instrument the laboratory cannot justify. The report also comes from a defined accredited scope, which is worth something.

What makes a certificate of analysis trustworthy?

A qualified supplier, named methods, actual results rather than conforms statements, and periodic verification of a lot against your own testing. A certificate alone from an unqualified supplier is a claim.

Browse by service class

• Compare Gene synthesis on advertised prices