Commissioning and Qualification: ASTM E2500 vs Traditional IQ OQ PQ

Commissioning and qualification (C&Q) is how a regulated manufacturer shows that new equipment is installed correctly, works as intended and is fit for its use. The traditional approach adds formal qualification stages after commissioning: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), each run against protocols approved by quality, and often repeating tests already done by the supplier. The ASTM E2500 approach is science and risk based: it focuses verification on the aspects critical to product quality and patient safety, uses good engineering practice, and lets properly documented supplier and commissioning tests count.

For a buyer, the difference is decided early. The tests you can rely on later are the ones you specified, and paid for, in the RFQ.

Why this matters now

The main reference points, a standard and two regulators, are all moving towards risk based verification. ASTM's guide for the specification, design and verification of pharmaceutical manufacturing systems is now in its 2025 version, E2500 25, and states that it applies to process equipment, utilities, control and automation systems across their lifecycle, consistent with ICH Q8 to Q11 [1]. In Europe, a revision of GMP Annex 15 on qualification and validation is under way: the concept paper, agreed with PIC/S in January 2026, plans to align it with the revised ICH Q9 on quality risk management, with a draft guideline planned for consultation in December 2026 and publication in 2028 [2]. And in the US, FDA's final guidance on computer software assurance, issued in September 2025, encourages effort matched to risk and the use of vendor assessments and system records [3].

Traditional and E2500 compared

Under the traditional model, every system goes through IQ, OQ and PQ protocols; see our guide to IQ, OQ and PQ. Under E2500, the team starts from product and process knowledge, identifies which aspects of the system are critical, and verifies those rigorously, while the rest is covered by good engineering practice and commissioning. ISPE's Baseline Guide on commissioning and qualification, second edition 2019, follows the same direction, covering how to apply quality risk management to C&Q, URS, design review and design qualification, and good engineering practice documentation standards [4].

Neither approach is a licence to do less where it matters. The aim is to put effort where risk is, and to stop repeating tests that add nothing.

Who does what

Supplier involvement is the hinge. ISPE's GAMP 5 second edition makes the same point for computerised systems, putting more weight on suppliers and service providers and on critical thinking by subject matter experts [5].

Reusing supplier tests: FAT and SAT

EU GMP Annex 15, revised in 2015, starts qualification from user requirements, adds design qualification and factory and site acceptance tests, and allows tests and documentation reviews from the factory acceptance test to be used in later qualification instead of being repeated, where appropriate and assessed; qualification documents can also be combined, for example IQ and OQ [6].

For a supplier test to be reusable, it usually needs:

• a test procedure agreed before the test, with acceptance criteria;
• calibrated test instruments, with certificates;
• results recorded at the time, signed and dated;
• deviations recorded and resolved;
• witness or review by the owner's engineering or quality team where the aspect is critical;
• change control after the test, so nothing changes before the equipment leaves the factory without being assessed.

Our checklists for the factory acceptance test and the site acceptance test cover the practical steps.

What to put in the RFQ

Ask bidders to price these items. Testing to a documented standard costs the supplier time, and an unpriced requirement tends to disappear.

Common pitfalls

• Calling it E2500 but running it the old way. If quality still rewrites every supplier test as a new protocol, nothing is saved.
• Leaving critical aspects undefined until site. The supplier cannot test to a list that does not exist when it quotes.
• Accepting supplier tests without seeing the raw records. A summary certificate is not enough evidence for a critical aspect.
• Changing the skid after FAT without telling anyone. A modification after the test can void its reuse; the order should require notification of any change.
• Treating the approach as a quality matter only. Engineering, procurement and the supplier all have to plan for it, and the plan starts with the RFQ.

Practical example

In this illustrative example, a cleaning in place skid has 120 test items in the supplier's factory acceptance test.

Under a traditional approach, the owner repeats 80 of them on site as IQ and OQ, for 200 test executions in total. Under an E2500 approach, the risk assessment identifies 25 critical aspects. The supplier runs all 120 tests to an agreed procedure, with the owner witnessing the 25 critical ones; on site, 15 tests affected by transport and installation are repeated during the site acceptance test, and the verification report references the rest. That is 135 executions, 65 fewer, about a third less test effort, with more attention on the tests that matter.

The saving only happens because the RFQ required test procedures, calibrated instruments and witness points from the start.

Where ChemCapital fits

ChemCapital sends one structured RFQ with line items and attachments, such as your URS, test expectations and document list, to several suppliers, so testing and documentation are priced in every bid. Quotes come back in a consistent format and are checked for missing fields and compliance gaps, and after award each order carries its own message thread and milestone updates, which keeps FAT dates and witness arrangements with the order they belong to.

Ready to put qualification expectations into every equipment RFQ? Start free with ChemCapital.