We exercise Qualification and Validation activities in healthcare and allied industries to ensure the safety, efficacy, and high quality of the end products.
It is difficult to assure “Quality” by only performing “in-process checks” and “finished product” testing. In other words, “Quality” must be brought into the product through each step of manufacturing.
Industries have various equipment, processes, utilities, facilities, and other supporting functions. These systems get used in the manufacturing of drugs, vaccines, or medical devices.
Therefore, these systems undergo qualification and validation activities as part of the regulatory requirements. These activities are performed to ensure the system designed, as-built, and performs as intended.
Let us brief on individual terms. After that, we’ll unfold major key differences between them.
You may find a logical similarity between different guidelines available, e.g. ISO-13485 with 21 CFR Part 820 and so on. The primary purpose though remains the same.
Qualification is objective evidence that equipment or system and its ancillary systems correctly installed, working as expected, and fit for the intended use.General understanding taken from various guidelines
Validation is the collection and assessment of data from process design to commercial phase, which establishes objective evidence that a process can consistently deliver a quality product.General understanding taken from various guidelines
Qualification term relates to instruments and equipment. This means instruments and equipment tend to qualify.
Validation term relates to processes. This means the process tends to validate.Pharmacopeil Forum, 2006:32(6), 1784-1794 USP General Chapter <1058>
Apart from the above mentioned, sometimes utilities also require validation. This can conclude through risk assessment during the process development phase.
Critical utilities include Electrical accessories, HVAC, Vacuum, WFI, Pure Steam, Purified Water, etc. For utilities with controllable input-output, qualification may be sufficient and may not require validation.
Also sometimes, equipment related to critical manufacturing steps may undergo process validation rather than to qualify. This becomes an added benefit for challenging the reproducible outcome of the equipment for the defined product.
Interpretation of these two terms slightly varies for medical devices compared to pharmaceuticals; however, the intent remains the same.
Medical devices follow ISO-13485 and 21 CFR Part 820 guidelines for process validation approach, and not the outlined set of rules for pharmaceuticals. However, documentation requirements remain consistent. For more information related to this, please read Good Documentation Practices.
The intention of this article is to provide basic key differences and let us look at the difference between these two terms.
|Deals with equipment or instruments.||Deals with process primarily and sometimes with critical equipment.|
|We challenge the performance of the equipment.||We challenge the complete manufacturing process.|
|The approach includes DQ, IQ, OQ, PQ, Calibration, Maintenance, etc.||The approach starts from the Process Design stage, Process Verification, Process Confirmation, Process Qualification, etc.|
Sometimes, the approach also attributed to Prospective, Retrospective, or Concurrent validation.
|Does not demand a reproducible outcome. Only concerned about the proper functioning of the system and sub-systems.||Specifically intended to challenge reproducible outcomes.|
|Ensures equipment or system and its sub-systems installed correctly and operates as required and perform as intended.||Ensures the process is capable to produce consistent results within the approved specifications.|
|Qualification is part of Validation.||Validation also covers the qualification of systems or equipment out of complete scope.|
|Validation can not start unless all required equipment, system, or utilities are qualified.||Equipment, utilities, and facilities must be qualified prior to validation.|
|We execute qualification following a DQ, IQ, OQ protocol to qualify the equipment.||We execute validation following a validation plan, protocol including SOPs using Qualified equipment.|
|Mostly, different equipment qualifications can perform simultaneously being independent of each other.||Within validations, supporting processes require validation prior to validating the key process.|
|Re-qualification needed for:|
1. Significant modifications critical to the outcome
2. Post relocation
3. Software and control modifications
4. Periodic Schedule
|Re-validation needed for any change in:|
1. Process or its environment
2. Starting material
3. Packing material
4. Steps or Procedure
6. Periodic Schedule
Though, it is required to note that Qualification is a part of Validation and not a separate entity to deal with. If you know, V-model for validation is the best way to interpret how the life-cycle revolves around distinct parts of validation.
How do you differentiate the qualification and validation within a healthcare industry? Let me know in the comments below.