Buying equipment does not also give you permission to use it in a pharmaceutical environment; qualification and validation are still in your way. Their primary goal is not to prevent you from using your equipment or to increase its costs, but to help you ensure consistent quality of final products.
At Sensum, we interact with many pharmaceutical quality assurance teams on the topic of qualification and validation, as we develop and provide solutions for automatic visual inspection of end products, which need closer supervision by quality assurance than quality control systems. For more than 15 years, we have experienced different qualification scenarios, which allowed us to identify several good practices. In the following paragraphs, you can find practical insight into the process of qualification with some useful tips that might help you with any qualification project.
First things first; What is validation and what qualification?
Validation is a larger concept than qualification and is related to processes such as the manufacturing process. It can be simply explained as a systematic approach that checks and helps processes to have expected and consistent results. Validation does not involve only equipment, but also various supplementary systems, software and people, which are part of the process.
Validation breaks down to several activities and one of those is the qualification, which is related to introducing systems to the process. The job of qualification is to make sure that a particular system is meeting regulatory requirements, industry standards and expected performance.
The (in)famous V-model
The extent of qualification depends on the complexity of the equipment. For example, the qualification of an intermediate bulk container should require less effort in comparison to a visual inspection system. We shall take a look at the qualification of a configured computerised system, which covers all typical qualification steps. The qualification procedure for the example is presented in the V-model below with two phases, specification and verification.
Specification phase: from URS to DQ
User Requirements Specifications (URS) are prepared by the final user who lists their expectations and requirements for their process. URS is a basic document that streamlines the entire qualification process.
After the URS are agreed and approved, they are typically shared with several potential suppliers. Each supplier replies to URS with a quote and bunch of Functional Specification (FS) documents, which are difficult to read and often impossible to link with each URS point.
Once the suppliers provide their feedback, it is time for Design Qualification (DQ). As mentioned in the introduction, the scope of qualifications depends on the system’s complexity. In this example, the DQ has three steps – proposal evaluations, risk analysis and setting up tests, which sounds problematic with a huge amount of work, but with proper setup, it is manageable.
In the first step of DQ, the user has to check if the supplier meets the requirements described in URS. Needless to say, if a supplier cannot meet all requirements, talk to them and find acceptable solutions for both or choose more appropriate supplier/solution. If you appended URS with FS as proposed in this article, a major part of the DQ can be done by commenting back to the supplier’s comments.
The second step of DQ is risk analysis and is started only after the first step is agreed between the user and the supplier. The outcome of risk analysis are points and specifications, which need to be tested and addressed during qualifications.
The last step of DQ is setting up qualification tests for the verification phase of the V-model. The tests should check, weather the supplier is really providing everything as agreed and should address any risk that was above risk threshold.
The final result of DQ is Traceability matrix, which links risks and requirements with tests.
Verification phase: Finally, the IQ, OQ and PQ
When specifications phase is finished and supplier is ready for the installation, the verification phase begins. The user and supplier will follow IQ/OQ protocols and the user will conclude qualifications with PQ.
IQ/OQ is typically done twice. Firstly, it is done at supplier place as part of factory acceptance tests (FAT). During FAT, any changes to the system due to requirement changes (oh, those happen often) or due to possible deviations are not as expensive as later, when the system is outside of manufacturing facilities.
Secondly, IQ/OQ is repeated with the same products after final installation at user’s site as part of site acceptance tests (SAT).
Performance Qualification (PQ) is performed by the user after successful SAT. The user should have prepared a Standard Operation Procedure (SOP) and follow it during the PQ. Products made/processed after successful PQ can be already used commercially.
This article was originally published in Pharmaceutical Technology: