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Qualification And Validation
In the pharmaceutical manufacturing industry, Validation is a very important part of Quality assurance. FDA gives special emphasis on Validation. It is one of the prime requirements of all the regulatory authorities worldwide. Our technical experts are well-versed with respect to respective manufacturing process in compliance with the latest regulations and evolving expectations.
Qualification
Qualification of systems and equipment is therefore a part of the process of Validation. This is an important service to verify the facility, process and equipments of the project for its standard and quality.
Our services at Lotus Group checks for the following compliances:
- Installation Qualification (IQ): Installing Testing as per the approved specifications of construction and materials
- Operational Qualification (OQ): Operational testing in different ranges of capacity
- Performance Qualification (PQ): Performance testing as per the acceptance criteria
Qualification Scope
In entirety, the qualification service involves the following steps for protocols and testing:
- User Requirement Specification (URS) and/or Technical Specifications (T.S) drafting for the client
- Agreeing on Design Review (DR) or Design Qualification (DQ) with the vendors
- Factory Acceptance Tests (FAT) – Protocol and Testing
- IQ, OQ, and PQ – Protocols and Testing
- Process Qualification
Validation
A documented evidence for robustness and reliability, the Validation service proves a high-degree of assurance to determine the consistency of a system, equipment or process. As Lotus Group recognises that validating system components is not one-size-fits-all, we offer customized Validation services as per the client’s requirements.
We specialise in conducting on-site Clean Room Validation regularly as per the BS EN ISO14644, PIC/s, WHO, ISPE and FDA standards for research and production pharmaceutical facilities, including hospitals, laboratories: on following design conditions.
- As Built conditions
- At Rest conditions
- In Operation conditions
Our Clean Room Validation Services include but not limited to,
- Air Flow Rates
- Air Change Per Hour (ACPH)
- Airborne Particulate Cleanliness Counts
- HEPA Filter Integrity Leak Testing– DOP Method
- Differential Pressure Measurements
- Magnehelic Pressure Gauge Calibration
- Temperature, Humidity, Light and Noise Level Readings
- Recovery Performance Testing
- Airflow Visualization Tests supported by Video and Written Reports
- Airflow Balancing and Remedial Works
- Complete documentation as per cGMP requirements
