Operational qualification ensures that the equipment works as planned and that its proper function is guaranteed across the entire range of process critical parameters. Operational qualification begins after successful completion of installation qualification.

To check the predetermined functionality of all components of the equipment, test procedures are developed and corresponding acceptance criteria are defined in advance. The essential elements of operational qualification are summarised in figure 6.F-2.

The following requirements for the execution of the function tests are considered to be indispensable:

• Completion of initial calibration: the quality-relevant measuring points must be calibrated.
• Use of calibrated test equipment: It must be possible to trace the equipment used for tests during the OQ to an accepted norm.
• Completion of testing for electromagnetic compatibility (EMC)

Possible operating constraints, such as the containment of the originally intended working area, which result from the qualification, must be listed in the operating procedure. At least a draft form of the operating procedures must be available for operational qualification and upon completion of this qualification phase they should enter into force. The operating procedure then becomes a requirement for staff training and thus ultimately becomes the basis for qualified operation of a qualified piece of equipment.

Operational qualification is not usually product-specific, i.e. it extends across the entire range (working area) of the different functions of the equipment. In addition to the working area, ancillary conditions should also be tested here (e.g. the restart behaviour after switching the equipment off).

In principle, it is recommended that all qualification activities be accompanied by deviation lists. If deviations occur, they are recorded in the list and a time by which they should be eliminated and the person responsible for doing so are defined. Qualification activities are then resumed depending on the significance of the deviation that occurred, or are interrupted and only continued once the deviation has been eliminated.

Successful execution of the installation and operational qualification represents the prerequisite for technical acceptance of the equipment and should be carried out as close together as possible.

6.F.1 Examples of OQ plans

The general requirements of the qualification documentation are described in chapter 6.C Qualification documentation. There are numerous ways of structuring the individual documents. A possible systematic procedure is presented in this chapter. The forms may be used as a template for filling with the facility-specific test points. The documents are structured so that the qualification plan (list of the test points with acceptance criteria) and the test protocol (documentation of the test carried out) are summarised in a single document.

The following forms are included:

• OQ test protocol Safety devices page 4
• OQ test protocol Risk analysis Operating functions page 6
• OQ qualification report page 11
• Qualification plan Test protocol OQ 3:
  Verification of the check for the presence of screw caps page 8

6.F.1.1 Safety devices

6.F.1.2 Risk analysis Operating functions

6.F.1.3 Check for the presence of screw caps

6.F.1.4 OQ report

6.F.2 Example: Fluid bed dryer

Only the measures that must be carried out (sometimes using forms) during operational qualification are listed below using a fluid bed dryer for illustration purposes. Computer validation measures are dealt with in chapter 9 Computer Validation.

Test equipment required for qualification

The test equipment required to carry out the operational qualification (OQ) must be listed (see figure 6.F-7). It must be ensured that the calibration can be traced back to certified standards, e.g. national norms, NIST (National Institute of Standards and Technology) or corresponding institutions. It must be checked that the time interval prior to recalibration has not been exceeded. Copies of the documents from the last calibration of the test equipment used must be included with the equipment/qualification documents.

Calibrations

The quality-relevant M&C points (measuring and control points) have been named. A copy of the compiled list can be found in the installation qualification report. The measuring circuits must be calibrated before the operational qualification is carried out. A copy of the calibration report is saved in the OQ report (see chapter 4.G Calibration).

Alarms

All alarms that indicate malfunctions in the facility must be checked by simulating the appropriate malfunctions. The type of simulation must be described in the form and documented. Care must be taken to ensure that only authorised personnel carry out these simulations.

Safety devices/locks

All safety devices in the facility must be checked to make sure that they are functioning correctly. "Safety devices" means all equipment that protects the operator from personal injury and the facility from improper handling. The tests may be documented with the aid of the form (see figure 6.F-8).

Flow rate test

The facility is started with a flow rate of 1000 m³/h without heating output and without product (this corresponds to the minimum capacity). The air velocity is measured and recorded at three different measuring points. This measurement is then repeated with a flow rate of 3500 m³/h and 6000 m³/h. The values determined at the various measuring points are compared with one another and assessed. The test is documented using a form.

Volume flow regulation

A check must be carried out to verify that the flow rate is being controlled correctly using three different flow rates. This involves starting the facility with a flow rate of 1000 m³/h without heating output and without product. This setting is maintained for 15 minutes. The flow rate is then increased to 3500 m³/h for a further 15 minutes and then finally to 6000 m³/h for 15 minutes. During this time the control must maintain a stable value that falls within the specified range. The tolerance values are specified in a form where the results are also documented.

Spray rate

The facility is to be prepared as if a product cycle was about to be carried out. It is started with a flow rate of 2000 m³/h without heating and without product. The spray medium to be used is water. Measurements must be carried out for 10 minutes with the minimum, with 50% and with the maximum spray rates respectively. The spray quantity is determined by weighing. The trial must be carried out three times for each spray rate which must not deviate by more than ±5%. The tests are documented in a form.

Heat distribution

To check the heat distribution, the facility must be prepared as if a product cycle was about to be carried out and must be started with a flow rate of 3000 m³/h without a product load. The temperature is set at 50 °C. Following a five minute warm-up phase, the temperature is measured at five different points above the sieve screen for 10 minutes. None of the measured values may deviate by more than ±5 °C from the average value determined above the screen. The trial is repeated at 80 °C and 110 °C. The tests are documented in a form.

Temperature control

The temperature control is checked without a product with a flow rate of 5000 m³/h, at 50 °C, 80 °C and 110 °C respectively. After the five minute warm-up phase the temperature must settle down to a constant level which is maintained for 10 minutes. The same procedure is then carried out for temperatures of 80 °C and 110 °C respectively and the control checked. The deviations must not be more than ±5 °C from the preset value. The results must be documented. A printout of the plot must be included with the OQ report.

Screen masks

Checks must be carried out to verify whether the screen masks perform the functions they have been assigned. It must be ensured that the operational parameters can be modified within their assigned limits. It must be possible to save new formulations with the programmed operational parameters and retrieve data again. The temperature, humidity and pressure values displayed are checked during calibration. A hardcopy of each screen mask must be made and amended to the form.

Equipment functions

This involves testing of specific functions of the facility such as the "on/off" or "raise/lower". The decision as to which tests should be carried out is based on results from the risk analysis (see chapter 6.B.6 Risk analysis). The tests are documented in a form.

Product cycle

To check the entire sequence of functions in context, a trial run must be carried out with the product. The manufacturing instructions for the product must be used as the basis for the trial run. The final product is tested in accordance with the approved test specifications. The performance of the test and the results must be documented (see figure 6.F-9). The product cycle data may be used as well for the performance qualification and process validation.

Batch record

The recording of a batch starts when the process begins and ends when the container is lowered. It must be ensured that the process data entered and the measured values gathered in the batch record is reproduced correctly. To check this, the batch record for the test run described above must be additionally recorded manually in a form. Once the trial has ended, the batch record which is generated automatically is compared with the manually recorded data. There must be no deviations.

Data backup

Checks must be carried out to determine how the system responds in the event of a power/utilities failure. It must be ensured that the operating data that has accumulated up to this point is not lost in the event of a sudden power/utilities failure. The facility must also be capable of continuing with the last process status following restoration of the power/utilities and subsequent confirmation. There must be no deviations in the parameters set or the process data. The test is documented using a form.

Access protection

It must be demonstrated that unauthorised individuals cannot access the system and manipulate data. A check must be carried out to determine whether operational parameters can only be modified by authorised personnel. The test is documented using the form.

Deficiency report

Deviations identified during the operational qualification must be documented in the deficiency report. The responsible department defines corrective actions, names the departments or persons responsible, specifies deadlines, and initiates implementation of the measures. All corrective measures performed must be documented.

It must be ensured that changes made, as a result of corrective actions, are assessed and documented in accordance with the established change control procedures, and a requalification carried out as required.