A pharma machine should come with a qualification pack: design qualification (DQ), installation qualification (IQ) and operational qualification (OQ) documents, plus support for performance qualification (PQ). The maker supplies the documents and helps run them, but your company owns the qualification and runs PQ.
In the EU, the main reference is Annex 15 of the EU GMP guide on qualification and validation. US manufacturers follow FDA expectations for equipment qualification and process validation. Your quality team decides how the pack must be structured.
What each stage means
- The user requirement specification (URS) is written by you. It states what the machine must do, in measurable terms.
- Design qualification shows that the proposed design meets the URS. It is usually a review of drawings and specifications before the build starts.
- Installation qualification checks that the machine was delivered and installed as designed, with the right parts, materials, utilities and documents.
- Operational qualification shows that the machine works across its operating ranges, including alarms, interlocks and controls.
- Performance qualification shows that the machine consistently makes acceptable product under real production conditions. It is the user's responsibility.
Other documents to expect
The qualification protocols rely on supporting documents. Ask for these in your contract:
- A functional design specification and, for automated machines, a software design specification.
- General arrangement drawings, piping and instrument diagrams and electrical drawings.
- Material certificates for contact parts, as described in material test certificates.
- Surface finish reports and weld records for contact parts.
- Calibration certificates for every instrument that measures a critical value.
- Factory and site acceptance test protocols and reports.
- Operating and maintenance manuals, a recommended spares list and a traceability matrix linking URS points to tests.
- For computerised systems, documents covering electronic records, user access and audit trails.
Who does what
A common split works like this. You write the URS. The maker prepares the DQ, and you review and approve it. The maker runs the factory acceptance test, which you or your representative witness, as explained in FAT and SAT.
On site, the maker's engineer often runs IQ and OQ together with your quality team. You then run PQ with your own product and procedures.
Agree in the contract which protocols the maker supplies, which ones they execute, and in what language. Ask for sample protocols before you order, because quality varies widely between makers. A thin or generic pack can delay your plant start-up by months.
Check the documents against the machine, not just against a template. Serial numbers, instrument tags, software versions and part numbers in the IQ must match what is actually installed. Errors here are common and are easiest to fix before the machine leaves the factory, while the people who built it are still at hand.
Next step
We check qualification packs against your URS, witness factory tests and follow up missing documents before shipment. For installation, see who commissions the line abroad. To start, book a free sourcing review.