.svg)
.svg)
Analytical instruments provide scientifically proven data on products and samples and make sure they meet the specified standards. The instruments vary from simple to complex and combine both measurement function and software control.
Many types of equipment play a major role in ensuring the proper functioning of lab processes. The responsibility of complying with the set industrial standards ultimately falls on individual companies. Failing to comply with the current set manufacturer and laboratory practices, can result in grave consequences that may include regulatory restrictions.
Equipment mapping and qualification is a key element of compliance. These also decrease compulsory in-process controls and testing.
Pharmaceutical, medical, and biotech industries have the responsibility of mapping and qualification of their equipment. Any choice they make concerning the procedures should be justifiable to a regulatory agency auditor.
For reliability and accuracy of the quality control results, one should conduct the qualification of lab equipment. Equipment qualification on those that affect quality control results is necessary to ensure they are fit for the specified purpose. Equipment qualification and mapping give manufacturers and consumers the confidence and assurance that products produced are beneficial and safe for public consumption. Below is a detailed discussion on equipment qualification and mapping.
Equipment Qualification
It is the final series of tests and qualifications, ensuring that the critical requirements necessary for product quality are met. Equipment qualification ensures that documents and procedures needed to operate and maintain the device are in place. The step ensures the equipment provides valid data as per the medical institution requirements.
If equipment breaks down due to frequent usage and wear, it needs repairing. After repairing, the equipment has to go through requalification to continue working along with its operational specifications.
Documents that should be available in a quality control laboratory include:
-
Calibration protocols
-
Qualification and requalification reports
-
Instrument maintenance records
Pharmaceutical companies ought to come up with qualification plans that can be used as standards for equipment worldwide. The plans outline that the instrument is supposed to function safely and consistently as intended. As a means of validating that a particular apparatus meets the regulatory specifications, they take into consideration the DQ, IQ, OQ, and PQ protocols. These protocols are discussed in detail below.
Design Qualification (DQ)
Design qualification stipulates the parameters used to describe an instrument. The phase should ensure the device has the necessary function and performance criteria.
DQ ensures successful implementation of the apparatus for the purpose intended and to meet the laid out requirements. The phase confirms the stipulations outlined in the User Requirements Specifications, can be carried out acceptably before a new design is approved.
User verification ensures that the device stipulations meet the outlined demands and is enough for commercial off the shelf instruments. The user, however, should verify that a robust quality system is adopted. It is to ensure the reliability of the vendor specifications.
If the device usage changes or undergoes any software upgrade, DQ documentation should be reviewed and updated immediately. Investing quality time and resources in this phase is crucial as errors can have tremendous technical and business impacts.
Installation Qualification (IQ)
Installation qualification establishes that the equipment complies with the vendor design, specifications, and recommendations. It also confirms the proper installation of the instrument in the selected environment. The environment should be suitable for the correct use and operation of the appliance.
This phase ensures that the device meets all the specifications assuring one that it will operate as designed. IQ may apply to a new, pre-owned, onsite instrument or transferring a qualified one to a new location. It all depends on the risk assessment results.
The Ultimate Guide to GLP Compliant Temperature Monitoring in the Laboratory
GLP compliance is critical because temperature contributes to safety, accuracy, and precision in the lab.
Operation Qualification (OQ)
Operation qualification verifies that the instrument functions correctly and satisfies its agreed metrics in the selected environment. The phase is necessary as it demonstrates the instrument fitness for the performance criteria and ensures it works in line with the end user's requirements.
Activities in OQ should imitate actual testing conditions. These should include worst-case scenarios and should be repeated enough times for reliable and accurate testing results.
When determining OQ frequency, one should consider the instrument type, stability of the performance parameters, and the agreed acceptance criteria. For all parameters to be within the operational specifications, the time intervals selected should be of a high probability.
Performance Qualification (PQ)
Performance qualification is also known as user acceptance testing. It indicates that the device is consistently working according to the specified limits and maintains the agreed values.
As consistency is critical in this phase, the test frequency is higher than that in operation qualification. Execution of performance qualification should be under conditions similar to routine sample analysis. Testing is done on a daily or a weekly basis, or whenever the instrument is used.
The test frequency depends on the device stability and everything in the system that affects the analysis results. It is the protocol that determines whether the equipment is ready for use.
DQ, IQ, OQ, and PQ protocols assist one to select an equipment, purchase, install, and start using it for the intended goal. Documentation should be done upon completion of equipment qualification and should consist of:
-
Design and manufacturer qualification document
-
Installation qualification document, that is, the IQ protocol
-
Calibration certificate documenting the initial calibration
-
An equipment all activities’ log
-
Performance qualification test procedures and representative results
-
Entries on equipment’s ID in the laboratory’s equipment database
Equipment Mapping
Equipment mapping is selecting and dedicating specific equipment to perform a particular procedure on it by a qualified operator as per the operational specifications during the OQ/PQ process.
Mapping is necessary if you hope to achieve a target yield or wish to validate a method during a scale-up, tech, and site transfer of existing equipment or testing a newly manufactured instrument.
Equipment mapping can be described as the testing and proofing phase of equipment qualification as it is a subset of all activities and documents.
Laboratory equipment can impact the finished product quality. Therefore, one should follow the correct procedure of mapping and qualification. By following the set standards and regulations, pharmaceutical and biotech companies make equipment that functions accurately to give accurate results.
Equipment qualification and mapping are crucial for an institution's compliance in regulated industries as they also ensure the safety and quality of products.
Your Options to Temperature Mapping
This practical guide will help you find the best mapping solution for your company.
Let's Talk About Temperature Monitoring
Schedule a call with our experts today. We're here to support your cold chain monitoring project and help ensure it is successful.
