GMP · Validation

Qualification & Validation (DQ · IQ · OQ · PQ)

Qualification is the documented proof that facilities, equipment and utilities are designed, installed and operate as intended; validation proves that processes, cleaning and test methods consistently deliver the expected result. A GMP facility starts from its user requirements, and each stage is checked against the specification set before it.

DefinitionsQualification and validation

Qualification
Proving and documenting that machinery and equipment are built and installed as designed and operate as intended, giving the desired results.
Definition in Korean GMP (Annex 1)
Validation
Verifying and documenting that a specific process, method, equipment or system consistently gives results that meet predetermined acceptance criteria.
Definition in Korean GMP (Annex 1)
Facilities and utilities versus processes
Qualifying the facility, HVAC and water systems is the precondition for the product-specific process and cleaning validation carried out on them. A cleanliness class is not a validated process.
Korean GMP requirements
Manufacturing support systems such as the water supply and air-handling systems are validated per machine and equipment (Annex 1, 6.5), and computer systems that handle data are validated separately (6.6). Installations, process changes and manufacturing-environment changes that affect quality are validated under a pre-approved plan (6.1).

V-ModelV-model

The left side breaks the requirements down into ever more detailed specifications; the right side checks what was built against the specification at the same level. IQ is verified against the design specification, OQ against the functional specification and PQ against the user requirements, while DQ confirms before construction that the design meets the URS. A requirement missing from the URS is easily missed later, so a traceability matrix links requirements to tests at every stage and a risk assessment looks for gaps.

The V-model is a widely used industry way of presenting the stages; their definitions and order follow EU GMP Annex 15. Where justified, IQ and OQ can be combined in one protocol (IOQ).

StagesStage-by-stage checks

URSUser requirements specification
Purpose
The user defines what the facility or equipment must achieve. Every later qualification step is checked against it, so requirements have to be written so they can be measured.
What is checked
Intended use and cleanliness grade, room pressure and temperature/humidity ranges, water grade, demand and number of points of use, materials, controls, alarms and records, documentation
Typical tests
No tests; each requirement is numbered so it can be traced to the tests in later stages.
How acceptance criteria are set
Each requirement becomes the starting point for later acceptance criteria (for example 'grade B room meets at-rest particle limits', 'conductivity monitored continuously at the loop return').
Deliverables
URS document
DQDesign qualification
Purpose
Demonstrates before construction that the design complies with GMP and meets the URS. Correcting a drawing is far easier than correcting a built installation.
What is checked
That each URS item is answered in the design documents (traceability), personnel and material flows with the pressure cascade, HVAC zoning, materials, circulation and sanitisation of the water system, and risk-assessment outcomes
Typical tests
Document review (design review meetings, drawings, specifications and calculations compared)
How acceptance criteria are set
Every URS item has a design response; open items are recorded with an action plan.
Deliverables
DQ protocol and report, traceability matrix
IQInstallation qualification
Purpose
Confirms that the installed facility and equipment match the approved design and the manufacturer's recommendations.
What is checked
Installation against drawings, materials and components against specification and certificates, instrument calibration, construction records against the specification, operating and maintenance manuals and as-built drawings
Typical tests
HVAC: AHU and filter specification and installation, duct leakage, calibration of pressure and temperature/humidity sensors Water: pipe material certificates, weld records, slopes and drainage, cleaning and passivation records, valve and instrument specification and calibration
How acceptance criteria are set
The expected state of every item is written into the protocol beforehand (drawing number, specification, calibration due date); the item passes when the observed state matches.
Deliverables
IQ protocol (IQP) and report (IQR)
OQOperational qualification
Purpose
Confirms that the facility and equipment operate as designed across the defined operating ranges, including the upper and lower limits and worst-case conditions.
What is checked
Control functions, operating ranges, alarms and interlocks, behaviour in abnormal situations such as power loss and restart
Typical tests
HVAC: airflow and air changes, room pressure differentials, temperature and humidity, installed filter leakage, airflow direction, at-rest cleanliness, recovery, alarms and interlocks Water: loop flow and velocity, sanitisation temperature and time, conductivity and TOC instruments and alarms, pump changeover and interlocks
How acceptance criteria are set
Taken directly from the design specification and URS and fixed before testing (for example the design pressure range, the design air-change rate, an alarm raised at its set point).
Deliverables
OQ protocol (OQP) and report (OQR)
PQPerformance qualification
Purpose
Confirms that the required performance is maintained consistently under actual operating conditions, normally after IQ and OQ, using production conditions or a justified equivalent.
What is checked
Performance and its variation over a period, the effect of people and equipment being present, seasonal variation
Typical tests
HVAC: operational cleanliness, airborne, settle-plate and surface microbial monitoring, pressure and temperature/humidity trends Water: three phases of sampling at the points of use (WHO guidance: phases 1 and 2 at least two weeks each, phases 1 to 3 together at least 12 months)
How acceptance criteria are set
The applicable limits apply (cleanliness and microbial limits for the grade, pharmacopoeial water limits), and the results set the alert and action levels for routine control.
Deliverables
PQ protocol and report, and the limits for routine monitoring

Where justified, factory and site acceptance test (FAT and SAT) results can support IQ and OQ without repeating the same tests.

Protocols & ReportsProtocols and reports

Protocol
Approved before testing: it covers the object and scope, responsibilities, test methods and sequence, instruments used, acceptance criteria and record forms.
Deviations
Results outside the criteria, or steps not carried out as written, are recorded as deviations, investigated for cause and impact, and resolved. Raw data stay as recorded; if an acceptance criterion has to change, the change is scientifically justified and approved in writing.
Report
Summarises the results and raw data against the protocol, with deviations and their resolution, and states a conclusion. The next stage normally starts once the report is approved; moving on with open items needs an impact assessment, justification and a documented conditional approval.

LifecycleRequalification and change control

Change control
A change to premises, equipment, utilities or processes is proposed in writing, its impact on product quality and validated state is assessed, the requalification it needs is defined, and it is approved before it goes ahead; afterwards, its effectiveness is checked.
Requalification
Qualified facilities and equipment are evaluated at a defined frequency to confirm they remain in a state of control. The frequency and scope are justified by risk, reviewing monitoring trends, change history and deviations.

RelatedTAB, CSV and process validation

TAB (testing, adjusting and balancing)
Adjusting and measuring HVAC air and water flows to their design values. TAB is not qualification in itself; its measurements can serve as evidence within an approved qualification protocol.
Computerised system validation (CSV)
Control and monitoring systems that record GMP data or are used for GMP decisions are validated separately, following Korean GMP Annex 1 (6.6), EU GMP Annex 11 and industry guidance such as GAMP 5.
Process and cleaning validation
Product-specific process and cleaning validation is carried out on qualified premises and equipment.

SAMYOUNG ENG designs and builds HVAC and piping systems for GMP facilities like these, and has supported IQ and OQ documentation and testing as well as TAB.

ReferencesSources

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