According to the government rules and regulations, all laboratory systems, equipment, and utilities for service or manufacture must prove the suitability of the intended purpose and function according to the design. Installation qualification, operational qualification, and performance qualification verification protocols must be written. According to the setpoints, the protocols must verify and prove proper installation, operation, support utilities, and acceptable performance. These protocols must be approved before their execution. IQ OQ PQ Validation in San Francisco and IQ OQ PQ in San Diego are executed according to these procedures and the FDA requirements. FDA requires that the verification of equipment specifications have been met by confirmation through examination and provision of evidence. At Biotechnical Services Inc., you can trust us with all your validation protocols in your organization. We have the technical expertise and experience of IQ OQ PQ Validation in San Francisco.
Types of Validation Protocols
- Installation Qualifications (IQs)
- Operation Qualifications (OQs)
- Performance Qualifications (PQs)
Installation Qualifications (IQ)
Installation qualifications show that equipment or a process is installed appropriately and meets all the specifications, and all documentation and components required for operation are installed. The IQs ensure that the system or equipment and the components are installed according to the manufacturer’s specifications. During this stage, the calibration of equipment and accessories is carried out. Other factors under installation qualification are environmental conditions, safety features, design features, and supplier documentation. IQs’ design processes are equipment, environment, piping, lubricants, valves, alarms, safety devices, utilities, and instrumentation. If you want installation qualification for your laboratory equipment, contact us at Biotechnical Services Inc. for the best services. We offer the best IQ OQ PQ in San Diego and its environs.
Installation Qualification Requirements and Sections
- Purpose: It shows the qualification needs of the intended equipment
- Equipment Description: It describes what the intended equipment does, processes, how to use it, and the design features
- Scope: It states whether the qualification is for modification of qualified equipment or a new piece of equipment
- Equipment Components: It describes the equipment components and their boundaries with the other systems in place
- Supplier: It shows the vendor and safety verification
- Utilities: It lists all the utilities associated with the equipment
- Installation Requirements: It indicates the cleaning procedures after the installation and recording of the equipment
- Documentation: Lists documentation that is used to operate the equipment and its manuals
- Maintenance Programs: It indicates procedures for preventive maintenance
- Spare: It lists the spare parts and change parts
- Testing and Acceptance: It defines the test procedure before the execution of IQ
- Drawings: It shows system drawing to support IQ
- Summary: It shows the outline of IQ results
Operational Qualifications (OQ)
The OQs provide evidence that the equipment operates according to the manufacturer’s specifications. During operational qualification, parameters of the process or a system are documented. The OQs are independent variables associated with the equipment or a system. All the measurements and test data must be verified.
Operational Qualification Requirements and Sections
- Purpose: It indicates the qualification needs of the system or an equipment
- Scope: It indicates whether the qualification is for modification or a new equipment
- Equipment Description: It shows what the equipment does, design, and what process use it
- Equipment Calibration Verification: It lists the calibration dates and the record of qualified test equipment and materials to be used during the protocol
- Prerequisites: It verifies the IQ tests
- Standard Operating Procedures: It states operating, cleaning, and maintenance procedures
- Operating Parameters: It identifies the critical operating parameters according to the manufacturer
- Alarm and Control Challenges: It identifies alarm challenges associated with the equipment
- Testing and Acceptance Criteria: It states the test range for verification parameters
- Rationale and Sampling Locations: It provides the rationale for sample size, qualification approach, and critical testing parameters
- Test Results Documentation: It summarizes and confirms the test results
- Conclusion: It summarizes OQ results and concludes whether the equipment is validated
Performance qualifications (PQ)
PQ is the final stage of equipment and system qualification. During this step, the equipment or a system is tested to prove whether it can perform consistently for a long time according to the provided tolerance provided by the manufacturer. Sometimes, this process is performed together with the process validation. The performance qualification process determines if the equipment can provide consistent service. It combines the facility, equipment, utilities, trained personnel, and control procedures to produce commercial batches. The PQ confirms whether the process performs according to the expectation. The consideration of the PQ sampling includes process complexity, the volume of production, experience with a similar function and products, and the level of process understanding. At Biotechnical Services Inc., we have qualified and experienced personnel to handle your IQ OQ PQ Validation in San Francisco and San Diego.
IQ OQ PQ Validation in San Francisco follows the FDA regulations for a system, equipment, and utility verification. IQ OQ PQ Validation in San Diego seeks to demonstrate the suitability of a system or equipment and proves that it works according to the functional specifications of the manufacturer. If you want the qualification protocols for your organizations, contact us at Biotechnical Services Inc. for proper documentation and compliance according to the concepts of quality control and assurance of Good Manufacturing Practices (GMP). We provide FDA compliant practices for your validation protocols’ proper and perfect audit system.