Qualification Services – DQ, IQ, OQ, PQ
„Vital GMP Engineering“
GMP Qualification Operations
Objective
GMP qualification operations include analytical instrument qualification, process equipment qualification and commissioning & qualification for process facilities, premises and utilities. Qualification operations aim to verify that a process equipment or process facility is qualified and under control.
Definitions
Qualification verifies through documented activities that the process equipment, process facilities, analytical instruments, and devices, consistently operates according to specified specifications and quality standards.
Qualification activities ensure that the process equipment or process facility are properly designed, installed, and functions reliably to produce safe and reproducible products, satisfying regulatory GMP requirements throughout the product lifecycle.
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.
Qualification Process
The qualification process starts with the devise of the User Requirement Specifications (URS), which defines the laboratory’s functional and operational requirements, 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).
Qualified equipment complies with GMP regulations to receive manufacturing and marketing authorization
Our validation engineers at Stolley Engineering, 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 operations.
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
Our Qualfication Expertise
- Hands-on experience with qualification, maintenance and calibration within a GMP-regulated pharma and biotech 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, CAPA, and change control 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 requirements and ALCOA+ principles.
- Hands-on experience with risk management and life cycle management
Our GMP Compliance Expertise
Ability to interpret the GMP regulations and apply them to your validation concepts.
- European Commission’s Guide to GMP (EudraLex Volume 4)
- FDA’s CFR Title 21 Parts 210 and 211
- EudraLex Volume 4 Annex 15
- EudraLex Volume 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
- Coordination, monitoring and participation in maintenance, calibration and qualification activities in all GMP areas (quality control, manufacturing, IT-infrastructure).
- Contributing to calibrated, maintained and qualified process equipment in compliance with GMP, FDA, EMA, and ISO standards.
- Managing the GMP lifecycle: planning, execution, review, approval, and documentation.
- Coordination, participation and contribution to qualification operations with QC, QA, Manufacturing, and IT (DQ, IQ, OQ, PQ and commissioning).
We are contributing to regulatory requirements for GMP release of samples according to customer’s needs and exigencies.