Equipment Qualification: A Systematic Method

Abstract

Qualification is the process of determining or verifying that services, tools, and support systems can function within parameters for the purposes for which they were designed. It is a component of validation. A crucial component of the pharmaceutical quality system is equipment qualification. Regulatory bodies have been emphasising equipment qualification more recently. The process of certifying equipment begins with its design, which is guided by the functional and user requirements specified. Information on Design Qualification, which determines whether the suggested design of buildings, systems, and equipment is appropriate for the intended use, is provided in the review article. Performance qualification is the last step, which shows that the process will consistently produce an acceptable product under typical operating conditions. Installation qualification is the process of determining whether the equipment is constructed and installed in accordance with the design specification. Operational qualification is the process of challenging the process parameters to ensure that the product meets all requirements.

Keywords

Qualification, Pharmaceutical, Equipment, Regulatory bodies, Services

Introduction

Equipment calibration must be done on a regular basis. This is because instruments have a tendency to deviate due to difficult working circumstances, mechanical shocks, or exposure to high pressure or temperature. The tolerance level would determine the calibration frequency. When precise and regular calibration is required, it is necessary when the measurement's goal is crucial [1]. While these unofficial means of verifying that performance standards are fulfilled are useful, formal, documented equipment qualification—a procedure that yields far higher benefits—is the way to go. Equipment Qualification records performance checks carried out on a regular basis during the equipment's operational life, in addition to those carried out during the commissioning of a measuring system. In addition to being mandated by regulations in certain sectors, Equipment Qualification offers analysts the following advantages:

1. Documentation proving new equipment is suitable for its intended use. This is accomplished by thoroughly specifying every necessary feature of the measurement system and then demonstrating, prior to utilising the equipment for analysis, that it satisfies these requirements.
2. A lower chance of inaccurate test findings because the equipment's functionality has been demonstrated to be appropriate for its intended usage both prior to and throughout the course of its working life.
3. A guide for resolving issues that could arise while the conductivity measuring equipment is operational. The documentation for Equipment Qualification can serve as a reference guide to identify and address the root cause of any measurement issues.

A laboratory's equipment qualification program is essential to its quality system because it supports the creation and validation of appropriate test procedures as well as the identification of the Quality Control and Quality Assurance steps that must be taken to guarantee that test measurements are appropriate. The process of equipment qualification guarantees that test measurements produced by measuring apparatus are appropriate for their intended use[2].

Regulatory requirements: [3]

In order to ensure data and product integrity, facilities, systems, utilities, and equipment must be appropriately qualified and maintained, as shown by the ICH Q7a guideline. Further direction is given by PIC/S: "There should be data available to support and verify the operating parameters and limits for the critical variables of the operating equipment, even though it is not possible to undertake the details of either an installation qualification for established equipment or the detailed approach for an operational qualification. Furthermore, the protocols for the use of the equipment, including cleaning, calibration, preventative maintenance, operating procedures, and operator training, should be recorded and maintained as standard operating procedures (SOPs).

Equipment and utility qualification usually consist of the following tasks: [4]

1. Utilities, equipment construction materials, operating principles, and performance characteristics are chosen based on their intended purposes.
2. Utility systems and equipment are verified to be built and installed in accordance with the design specifications (e.g., built as specified with suitable materials, capacity, and functions, and properly linked and calibrated).
3. Confirming that, across all expected operating ranges, utility systems and equipment function in compliance with process requirements. This should involve putting the machinery or system to the test under loads similar to those encountered in regular production. The execution of interventions, halt, and start-up as expected during regular production should also be included. Operating ranges should demonstrate the ability to be maintained for as long as would be required during regular production.

Elements of Qualification [5-8]

The process of demonstrating that any technology functions properly and produces the desired outcomes.

Design qualification (DQ)

The formal confirmation that the equipment and system's suggested design is appropriate for its intended use.

Installation Qualification (IQ)

The formal confirmation that the system and equipment, whether changed or installed, adhere to the manufacturer's recommendations and the authorised design

Operational Qualification (OQ)

The recorded confirmation that, in the expected operating ranges, the installed or modified equipment and system function as planned.

Performance Qualification (PQ)

The documented confirmation, based on the authorised process technique and product specification, that the system and equipment combined can function efficiently and consistently.

Performance Qualification (PQ)

The documented confirmation, based on the authorised process technique and product specification that the system and equipment combined can function efficiently and consistently.

Qualifying Verification (VQ)

The verified documentation demonstrating that the system and equipment are still state-of-the-art when coupled together and that they genuinely produce the desired outcomes and meet user needs.

Safety Qualification (SQ)

The recorded confirmation that the system and equipment, as installed or modified, meet the process, facility, and personnel safety standards is known as the Safety Qualification (SQ).

Maintenance Qualification (MQ)

The recorded confirmation that the suggested maintenance regimen for the system and equipment is appropriate for its intended use is known as maintenance qualification, or MQ.

Re-Qualification (RQ)

The recorded confirmation that all of the interconnected systems are still operating at a satisfactory level. Re-qualification is necessary as a result of moving, making significant changes, and becoming older.

Need for calibration:

• Calibration can be called for
• with a new instruments
• When a specified time period is elapsed
• When a specified usage (operating hours) has elapsed
• When an instrument has had a shock or vibration which potentially may have put it out of calibration
• Sudden change in weather
• Whenever observation appears questionable

Checking the instruments' calibration tags allows you to determine their current state. The instrument name, purchase date, calibration date, next calibration date, and the signature of the calibrated individual with the date are all included in the tag. There are two methods for calibrating instruments: internal calibration and external calibration. Internal calibration is carried out by knowledgeable internal staff members. External calibration should be carried out in a government-approved individual or institution and is done in accordance with the manufacturer's instructions.

Qualification of Laboratory Equipment’s

1. Friability Test Apparatus [9]

• Turn on the power source.
• Utilising the stop watch, start the machines simultaneously while setting the RPM to 25. Instead of measuring the number of rotations needed, count the actual ones.
• Similarly set the RPM to 100 and note the time required and actual rotations.
• Apparatus is in proper working condition if,

1.  Time required for 25 rotations is 1 min ± 05sec.
2.  Time required for 100 rotations is 4 min ± 20 sec.

• Affix a “Calibration Status” label on the instrument.
• In case of any discrepancy, report the observations to QC manager / QA Manager and notify the defect to Engg. Department. Affix an ‘UNDER MAINTENANCE” label on the instrument.

Frequency:

Once in a month and after each maintenance job.

2. Hardness Tester[10]

Take out the force gauge to be calibrated and hold vertically up.

• Adjust the zero on the force gauge.
• Standard Weights are then applied to the hook of force gauge and measure the tension of the spring on the force gauge.
• When 1 kg of standard weight is applied, scale on the force gauge should also show 1 kg tension produced from the initial point where pointer is adjusted.
• Adjust the zero on the force gauge again.
• Follow the same procedure for other weights.
• The test to be carried out for 1.0 kg, 2.0 kg, 5.0 kg, 10.0 kg, 20.0 kg & 30.0 kg standard weights.

Tolerance:

± 0.25 kg / ± 0.1 kg

Frequency:

Once in 6 months

Maintenance & Repair If an instrument does not meet the aforementioned requirements, it should be marked as "Out of Calibration" and fixed or serviced. After repairing or fixing the instrument, it must be calibrated in accordance with the procedure outlined above.

3. Disintegration Test Apparatus [11]

A. Calibration for Number of Oscillations per minute

• Take a pre-calibrated stopwatch. Operate the apparatus as per SOP. Start the apparatus and stopwatch simultaneously and count the number of oscillations per minute.
• Repeat the same for five times and note down the number of oscillations per minute for each time.
• The oscillations per minute shall be within the limit of 29 to 32 through a distance of 53 to 57 mm throughout the period of operation. Record the observation

B. Calibration for Temperature:

• Switch on apparatus and press key.
• Turn on the heater by pressing ‘ON’ key.
• Set the bath temperature by pressing scroll keys.
• Wait till the temperature of beaker A and beaker B attain the set value.
• Screen shall show the set temperature of bath and the temperature of beaker A and beaker B.
• Take a pre-calibrated thermometer and check the temperature of beaker A and beaker B.
• Record the observation.

C. Timer Calibration

• Set the timer for ‘30 minutes’ and start the equipment and stop watch simultaneously. Note down the stop watch reading immediately when the equipment stops and note down the observation.
• Observed time should not deviate by ‘± 1 min’ of set time.

D. Sieve Integrity Test

Check the ‘integrity’ of woven stainless steel cloth (sieve) attached to the base plate of each basket with a pre-calibrated vernier calliper. The sieve has weaven squares of aperture of 1.8 – 2.2 mm and wire diameter of 0.57 to 0.66 mm. Note the observations.

• Affix the ‘CALIBRATION STATUS’ tag duly filled and signed on the equipment after completion of calibration.
• If the instrument is out of calibration then affix ‘UNDER MAINTENANCE’ tag and inform to maintenance department.
• The frequency for calibration of Disintegration Test apparatus shall be after every one month or after every maintenance work. [12, 13]

Documentation

The qualification process includes written documents that outline the qualification strategy, procedures, and results. These documents may include:

IQ Protocol:

A comprehensive plan that includes the scope, methodology, and criteria for the Installation Qualification (IQ).

IQ Checklist:

A detailed checklist that covers all aspects of the installation, including physical installation, electrical connections, calibration, software installation, and environmental conditions.

IQ Report:

A document that summarizes the findings, observations, and results of the IQ protocol.

CONCLUSION

Analytical tools provide dependable data. Manufacturing relies heavily on the performance of equipment. To ensure consistent performance, equipment must be properly qualified, verified, and maintained. Equipment qualification involves establishing necessary performance, selecting appropriate equipment, and assuring consistent performance to meet standards. This has numerous benefits for analysts.

• Obtaining and proving accurate results, in conjunction with other quality assurance and control procedures.
• Reduced unsatisfactory test measurements.
• Quickly identify and resolve any issues with measuring equipment during its lifetime.
• Significant long-term savings in time and money.

Validation ensures that equipment components perform properly and meet specifications. This ensures complete confidence in analytical measurements. This ensures that the equipment maintains its accuracy, reliability, and perfection.

Calibration is necessary to preserve an instrument's accuracy while in use.

REFERENCE :

1. Edward Simpson, Calibrating Specialist RSCalibration.com.
2. John J. Barron, Colin Ashton. Equipment Qualification and its Application to Conductivity Measuring Systems, Journal for Quality, Comparability and Reliability in Chemical Measurement. 11(11): 554-561.
3. Sharanya N, Ramasubramaniyan P, Jeya shree P, Srinag T, PalanichamyS, Solairaj P. An Overview on Qualification of Equipment – An Ideal Approach for Equipment Validation. Indo American Journal of Pharmaceutical Research. 2013; 3(10): 9013-9018.
4. Guidance for Industry Process Validation: General Principles and Practices, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), January 2011, Current Good Manufacturing Practices (CGMP), Revision 1, p-14.
5. Venugopal S. A Systematic Approach to Equipment Qualification. European Journal of Biomedical and Pharmaceutical Sciences. 2015; 2(3): 830-854.
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7. Nash RA, Wachter AH. Pharmaceutical Process Validation. 3rd ed. volume 129. Marcel Dekker Inc. 2003; 491.
8. Laura T U H Melero, Kátia S. da S. Silva,Camila Zanette, Elaine B. de Araújo, Jair Mengatti. Calibration and Qualification of Equipments in the Pharmaceutical Industry: Emphasis on Radiopharmaceuticals Production, International Nuclear Atlantic Conference. 2011; Belo Horizonte, MG, Brazil.
9. http://qualityassurancepharma.blogspot.in/2010/12/operation-and-calibration-of-friability.html
10. http://www.pharmaguideline.com/2011/02/calibration-of-hardness-tester.html
11. http://pharmaguidances.com/calibration-procedure -for-disintegration-testapparatu./
12. http://qualityassurancepharma.blogspot.in/search?q=calibration+of+disintegration+test+apparatus.
13. http://www.labulk.com/tap-density-testercalibration-procedures-labulk