What is Validation?
As per EU GMP – It is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results.
What is Qualification?
- Performed to establish evidence that process equipment and ancillary systems are capable of operating within established limits and tolerances.
- Provides documented evidence that the subject equipment has been installed as per specification (manufacturer’s recommendation) and will attain and maintain critical process parameters repeatedly and reliably.
Comparison between Qualification and Validation
- Qualification is normally used for equipment, utilities and systems.
- Validation is normally used for processes and methods.
- Qualification is often a part (the initial stage) of validation but the individual qualification steps alone do not constitute process validation.
- Process validation cannot take place without first carrying out qualification.
- Assures Quality
- Regulatory Requirement
- Reduces Cost
- Robust Process
What to Qualify/Validate?
- Test Methods
- Validation Master Plan (VMP)
- Validation Protocols (VP)
- Validation Reports (VR)
- Standard Operating Procedures (SOPs)
Validation Master Plan
- Contains key elements of the validation program.
- summary of facilities, systems, equipment and processes validated (and to be validated).
- A detailed document relating to a specific part of the validation process.
- Describes the procedure to be followed for performing validation.
- Description of the equipment to be used (including calibration before and after validation).
- Record of results obtained during the performance of the validation.
- Includes evaluation, analysis and comparison of results with acceptance criteria by the responsible personnel.
- Results should meet acceptance criteria and satisfy the stated objective.
Changes that Require Revalidation
- Software changes;
- Site changes;
- Change of source of material;
- Change in the process;
- Significant equipment change;
- Production area changes.
Types of Validation
- Process Validation
- Analytical Method Validation
- Cleaning Validation
- Water Systems Validation
- Computerized System Validation
Note: Validation should be completed prior to commercial manufacturing. Where this is not possible, it may be necessary to validate processes during routine production.
Types (Stages) of Qualification
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
Let’s explore the significance of each qualification and their role in achieving successful validation.
Design Qualification (DQ): The foundation of the 4Q model starts with DQ, which focuses on verifying that the design specifications align with intended use and regulatory requirements. It involves reviewing design documents, specifications, and functional requirements to ensure the system or equipment is suitable for its intended purpose.
Installation Qualification (IQ): IQ ensures that the system or equipment is installed correctly and according to approved procedures. It involves verifying that all components are present, installed properly, and conform to specifications. IQ also includes documenting installation details and conducting inspections to ensure compliance with applicable standards.
Operational Qualification (OQ): OQ assesses the system’s functionality and performance under normal operating conditions. It involves testing the equipment or system using predetermined protocols and criteria. OQ verifies that the equipment functions within specified operational limits, performs required tasks accurately, and meets predefined performance criteria.
Performance Qualification (PQ): PQ focuses on validating the system or equipment’s performance in the actual operating environment. It involves testing the system or equipment under real-world conditions to ensure it consistently delivers the intended results. PQ verifies that the system performs as expected, meets user requirements, and delivers reliable and consistent outputs.
Resource Person: Hassan Hussein