Qualification Services – DQ, IQ, OQ, PQ
„Vital GMP Engineering“
Key Activities
Stolley Engineering contributes to all qualification operations and qualification phases (DQ, IQ, OQ, PQ) including URS, risk assessment and lifecycle management.
About Qualification
Qualification include analytical instrument, process equipment and commissioning and qualification for process facilities, premises and utilities. Qualification aims to verify that a process equipment or process facility is qualified and under control.
Purpose
Qualification verifies through documented activities that the process equipment, process facilities, analytical instruments, and devices, consistently operates according to specified specifications and quality standards.
Objective
Qualification activities ensure that the process equipment or process facility are properly designed, installed, and functions reliably to produce safe and reproducible products, and satisfying regulatory GMP requirements throughout the process life cycle.
What are the necessities of 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.
Why GMP Compliance?
Qualified equipment complies with GMP regulations to support the manufacturing authorization.
Effective implementation of GMP qualification processes
The qualification process starts with the devise of the User Requirement Specifications (URS), which defines the laboratory’s need and the functional and operational requirements of the device. Subsequently, followed by the four qualification phases of DQ, IQ, OQ, and PQ.
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).
Hands-on Experience
- Hands-on experience with qualification, maintenance and calibration regarding a GMP-regulated environment.
- Hands-on experience with analytical instruments i.e. FACS, HPLC, PCR/qPCR, assay plate reader and laboratory and process equipment.
- Hands-on experience with PQS activities, including deviations and change control and CAPA and periodic review.
- Hands-on experience with commissioning & qualification (C&Q).
- Hands-on experience with computerized system validation (CSV).
- Hands-on experience with data integrity and ALCOA+ principles.
- Hands-on experience with risk assessment and lifecycle management.
Our Qualification Services
- Performing Testing Activities: IQ, OQ, PQ
- Devise of User Requirement Specifications (URS)
- Devise of DQ
- Devise of Risk Analysis
- Devise of Test Protocols
- Devise of Qualification Plan and Master Plan
- Devise of SOPs and Master SOP
- Devise of Qualification Reports and Final Reports
Ability to interpret the GMP regulations and apply them to your qualification concepts.
- European Commission’s Guide to GMP (EudraLex Vol 4)
- FDA’s CFR Title 21 Parts 210 and 211
- EudraLex Vol 4 Annex 15
- EudraLex Vol 4 Annex 11
- Directive 2017/1572/EC
- Regulation 1252/2014/EC
- Regulation 2017/1569/EC
- Directive 2001/83/EC
- WHO GMP
- ICH Q7 Good Manufacturing Practice
- ICH Q10 Pharmaceutical Quality System
- ASTM E2500
- ISPE Vol 5 Commissioning & Qualification
Your Qualification Benefits
We are contributing to regulatory GMP requirements to support GMP compliance.