Service · Commissioning & Qualification

Commissioning and Qualification to EU-GMP Annex 15

New plants and modifications are under schedule pressure, and qualification becomes the bottleneck as soon as commissioning and GMP evidence run separately from one another. Testing is then done twice, results from the factory acceptance test expire unused, and in the end the chain from the critical quality attribute to the executed test step is missing. We plan both as one continuous sequence, risk-based in line with ISPE Baseline Guide Volume 5 and ASTM E2500 and demonstrable in line with EU-GMP Annex 15, executed on site in ongoing GMP operation, from Visp in Valais.

ISPE Baseline Guide 5ASTM E2500EU-GMP Annex 15ICH Q9(R1)ALCOA+

Our C&Q services, with a clear deliverable

Every service ends with an audit-proof document, not a recommendation. What you actually receive:

C&Q strategy and system boundaries

We survey the equipment and systems, define their boundaries and assess their impact on product quality. From this follows which system is qualified and which is covered by Good Engineering Practice.

Result: C&Q plan with system list, system boundaries and a justified depth of testing for each system.

URS, Design Review and Design Qualification

We write user requirements that are unambiguous and testable, and we check the design against these requirements in the Design Review. For the DQ, Annex 15 requires documented evidence that the design complies with GMP requirements. The user requirements remain the reference point throughout the entire lifecycle and are evidenced through traceability into the executed tests.

Result: released URS, documented Design Review and DQ report with end-to-end traceability.

System Risk Assessment, Critical Aspects and CDE

From the critical quality attributes and process parameters we derive the Critical Aspects and name the Critical Design Elements that ensure them technically. The assessment follows ICH Q9(R1) and the ISPE Baseline Guide Volume 5 and is agreed with your subject matter experts and QA. Whether a system is qualified is decided by its GMP impact. Within a system subject to qualification, the Critical Design Element decides which test constitutes qualification evidence. Everything else is still tested, but in commissioning in line with GEP. Both decisions are released in documented form by the quality unit.

Result: released System Risk Assessment with a list of the Critical Aspects and Critical Design Elements.

FAT, SAT and justified Leveraging

We prepare the factory acceptance test and the site acceptance test so that their results hold: scope of testing against the Critical Design Elements, acceptance criteria before the test, deviations documented. Annex 15 allows document reviews and individual tests from the FAT not to be repeated on site, if this is justified and transport and installation demonstrably do not impair the function.

Result: assessed FAT protocols from the supplier, executed SAT protocols and a Leveraging decision released by QA, referenced in IQ and OQ.

Commissioning in line with Good Engineering Practice

We carry out the commissioning on site: installation checks, Loop Checks, functional tests, calibration of the critical measuring points and balancing of utilities and clean utilities. We keep the records so that they satisfy ALCOA+ and remain usable for qualification.

Result: commissioning report with completed installation and functional tests, plus calibration records for the critical measuring points with evidence of metrological traceability.

IQ, OQ, PQ and release

We prepare and execute the qualification protocols in line with Annex 15, with acceptance criteria defined before the test and a controlled handling of deviations. The report summarises test evidence, deviations and open points in such a way that QA can decide.

Result: executed IQ, OQ and PQ protocols and a qualification report as the basis for the release decision by your QA.

How a C&Q project runs with us

01

System boundaries and risk assessment

System list, boundaries against systems without GMP impact and System Risk Assessment with the Critical Aspects.

02

C&Q plan and specification

URS, Design Review, DQ and traceability matrix, agreed with your QA.

03

FAT and SAT

Acceptance tests against the Critical Design Elements, with a documented decision on Leveraging.

04

Commissioning on site

Installation checks, Loop Checks and functional tests, calibration and balancing in line with Good Engineering Practice.

05

Qualification and handover

IQ, OQ and PQ, assessment of the deviations, qualification report and handover to operations together with the requalification strategy. For clean utilities the PQ continues in phases, and the handover to operations takes place with a defined remaining scope and assigned responsibility for the ongoing phases.

What sets us apart from paper-only qualification

Close to engineering

We do not only write protocols, we execute them at the plant. Our engineers know process technology, utilities and clean utilities, which is why the protocol states what can actually be tested.

At home in Valais, on the road across Switzerland

Vispact is based in Visp, in the middle of the Swiss life sciences industry. Short distances within Valais, on-site assignments throughout Switzerland and in Germany.

Critical thinking instead of templates

Expert judgement is at the centre, and the criticality decisions and acceptance criteria are released independently by the quality unit. We test what carries risk, and we justify in writing what we leave out.

Documentation that holds up in an audit

From the critical quality attribute through the Critical Design Element to the executed test step, every chain remains traceable. That is the standard by which we let ourselves be measured.

Frequently asked questions on Commissioning & Qualification

What is the difference between commissioning and qualification?

Commissioning is the technical bringing into service in line with Good Engineering Practice: checking the installation, putting functions into operation, calibrating, balancing. Qualification is the documented evidence in line with EU-GMP Annex 15 that equipment, utilities and systems are installed as intended, function correctly and meet the defined requirements. The evidence that the process on this equipment reproducibly delivers product of the required quality is the subject of process validation. Both take place on the same equipment, but with a different burden of proof. Planned correctly, commissioning is the basis of qualification and not a repetition of it.

Which regulations apply to commissioning and qualification?

The authoritative reference is the EU GMP guide with Annex 15 on qualification and validation. In Switzerland it applies via Annex 1 of the Swiss Medicinal Products Licensing Ordinance (AMBV/MPLO, SR 812.212.1), which declares the EU GMP guide and the PIC/S guide PE 009 applicable side by side; where the two diverge, Swissmedic requires the stricter requirement to be met. This is supplemented by ICH Q9(R1) on quality risk management, implemented in the EU as Part III of the GMP guide. The technical implementation draws on the ISPE Baseline Guide Volume 5 on Commissioning and Qualification (second edition) and on ASTM E2500 in its E2500-25 version with its science- and risk-based verification approach. Neither is law, but both are regarded as the recognised state of the art. For computerised elements, EU-GMP Annex 11 applies in addition.

What are Critical Aspects and Critical Design Elements?

Critical Aspects are the functions, features and performance characteristics of a system that are required to ensure the critical quality attributes of the product and patient safety. Critical Design Elements are the design features that ensure these functions, for example a material selection, a control loop, an alarm or the slope of a clean utility line. The ISPE Baseline Guide Volume 5 makes them the pivotal point: the scope of qualification is determined by what a Critical Design Element covers. Everything else is still tested, but in commissioning in line with Good Engineering Practice.

Can FAT and SAT replace qualification?

In part, and only under conditions. Annex 15 allows document reviews and individual tests from the factory acceptance test not to be repeated at IQ and OQ on site, provided this is justified and the function is demonstrably not impaired by transport and installation. The precondition is that the scope of testing and the acceptance criteria were defined in advance and that the acceptance documentation remains traceable in the sense of ALCOA+. Anyone who clarifies this only after the acceptance test will as a rule test twice.

How does a C&Q project with Vispact start?

With an initial conversation of 30 minutes, without obligation. After that we survey the equipment and systems and clarify the system boundaries, the impact on quality and the critical points in the schedule. From this comes a C&Q plan with a justified scope of testing that your QA can support. A reply within one working day, directly from engineering.

Deeper reading from our practice

Let us talk about your plant.

Whether new plant, modification or requalification during operation: in an initial conversation we assess your situation, 30 minutes, without obligation. We evaluate changes within the operator's change control procedure, and from that we derive the scope of requalification. The C&Q plan is linked to the validation master plan. A reply within one working day, directly from engineering.

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