Qualification Services
„Vital GMP Engineering“
About Qualification Operations
Qualification operations include analytical instrument qualification, process equipment qualification and commissioning & qualification for process facilities, premises and utilities. The objective of qualification is to verify that a process equipment or process facility is qualified and under control.
Objective of Qualification
Qualification verifies through documented activities that the process equipment, process facilities, analytical instruments, and devices, consistently operate according to specified specifications and quality standards. Qualification activities ensure that process equipment and process facilities are properly designed, installed, and functions reliably to produce safe and reproducible products, satisfying regulatory requirements throughout the product lifecycle.
What are the necessities of analytical instrument and process equipment qualification?
Demonstrating that the equipment is suitable for its intended use is elaborate and labor-intensive. It depends upon experience and expertise, as there are predetermined specifications and GMP regulations to meet. It is, therefore, beneficial to know and have worked with the analytical instruments and process equipment.
Qualification and validation procedures are time-consuming and demanding. Delays affect manufacturing authorization and thus also impact clinical trial and marketing authorization. Therefore, to devise an effective qualification and validation strategy is of utmost avail.
Qualification process
The qualification process starts with the devise of the User Requirement Specifications (URS), which defines the laboratory’s technical and operational requirements, followed by the four qualification phases of DQ, IQ, OQ, and PQ, in which the URS should be part of the DQ.
Main qualification activities include risk assessment, system classification, testing activities along with vendor’s FAT and SAT and instrument calibration. A written qualification plan should specify how the qualification will be performed. The plan should be reviewed and approved by quality assurance (QA).
Qualified equipment complies to cGMP regulations for manufacturing and marketing authorization
Our validation engineers, who are well-qualified, have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to biopharmaceuticals and immunotherapies, allowing us to contribute GMP expertise to your qualification activities.
Our Qualification Services
Our Qualification Expertise
- Hands-on experience with analytical instruments and process equipment
- European Commission’s Guide to GMP (EudraLex Volume 4)
- EudraLex Volume 4 Annex 15
- EudraLex Volume 4 Annex 11
- ICH Q7 Good Manufacturing Practice
- ICH Q8 Pharmaceutical Development
- ICH Q10 Pharmaceutical Quality System
- ASTM E2500
- ISPE Vol 5 Commissioning & Qualification
- Data Integrity and Computerized Systems (CS)
Your Qualification Benefits
- Contributing to qualified instruments and process equipment
- Contributing to GMP compliance
- Contributing to manufacturing and marketing authorization
