Pharmaceutical and Medical Devices
KVALITO’s highly experienced CQV Subject Matter Experts perform Commissioning, Qualification and Validation activities for systems, equipment and laboratories in the life science sectors using industry best practices and sound scientific principles.
Risk management should underpin the specification, design, commissioning and verification process of all elements of manufacturing systems and equipment. Appropriate and effective solutions can be delivered by applying a Risk-Based approach and understanding the critical manufacturing aspects of a system, such as functionality and performance, whilst applying Quality by Design concepts and Good Engineering Principles (GEP).
KVALITO works with each client to tailor projects to meet their needs whilst ensuring the delivery of robust and compliant solutions.
Challenge
Challenges that can impact the ability to implement a robust risk-based CQV process include;
Regulatory Environment
The continuously changing regulatory environment creates both challenges and opportunities for CQV. Lack of interpretation of industry regulations can lead to not having a shared understanding of regulatory expectations which can impact the implementation of an effective risk-based CQV program. This can be addressed by having Commissioning and Validation Subject Matter Experts with compliance and regulatory expertise throughout all project phases. Also, using standard tools and templates (GAP Assessment, FMEA, Testing Templates) enables alignment with industry guidelines and standards.
Procedures and Tools
Having inadequate procedures and tools such as poorly constructed templates may impact the successful completion of a CQV process. This should be managed to ensure that the appropriate processes, systems and tools are in place at the outset of a project which then can be adapted and applied for any project. For example;
- Performing GAP Assessments against industry standards and regulations’ requirements can help define the scope.
- Using Risk management tools such as Process Flowcharts, Process Mapping, or a systematic, proactive method such as FMEA (Failure, Mode and Effects Analysis) should be considered.
Early adoption of adequate tools and procedures within the CQV lifecycle facilitate consistency, efficiency, and compliance to ensure that the systems are designed and verified to be fit for their intended use.
Good documentation practices (GDP)
Good documentation practices are critical for implementing and maintaining an adequate risk-based CQV program.
- Good documentation practices should be followed to ensure that all paper and electronic records allow the full reconstruction and traceability of all GXP activities.
- Provision of GDP training to all parties involved in the CQV activities, i.e. Test Teams including Third-party Contractors and Vendors on the execution of test documents.
- Emphasising how Good documentation practices can support the leveraging of Vendor Documentation which leads to smoother project completion and overall efficiency.
Project Constraints
Lack of understanding of the project scope, requirements and resources can impact the successful delivery.
- Scope Definition -It is critical to put the effort in at the outset of a project with the key stakeholders to ensure that the project scope, resources and plans are clearly defined and understood.
- Robust User Requirements – is a critical factor to the successful execution of a CQV Project. The User Requirements Specification describes the business needs for what users require from the system and can be categorised into business (requirements from the process), system, technical, regulatory, quality requirements, etc. It is essential to ensure that the requirements are clear and testable. Therefore it is important to have the product and process knowledge that forms the basis of scientific understanding.
- Change management processes should be established and applied throughout the lifecycle. Changes affecting critical aspects of the ‘manufacturing, laboratory system etc., should be communicated to the SME and Quality function promptly so they can be suitably assessed and addressed.
What KVALITO does
KVALITO has provided support to pharmaceutical, medical devices and Lifescience clients in the following areas;
- Validation Project Management
- Commissioning, Qualification and Validation of equipment (Manufacturing and Laboratory systems) and facilities.
- Validation of Analytical and Immunoassay instruments for Microbiology Laboratory Equipment, including new technologies.
- Generation and Execution of CQV Documentation, i.e. Validation Plan, Test Strategy, User requirement specifications (URS), Impact/Risk/FMEA, Design Qualification (DQ) documents, IQ/OQ/PQ -Installation Qualification, Operational Qualification, Performance Qualification, Requirement Traceability Matrix, Test Reports and Final Validation Reports.
- Review of commissioning documentation (e.g. Factory Acceptance tests, Site Acceptance Tests, Installation verification, etc.)
- Provide guidance and methodology on Leveraging Vendor Documentation as part of the CVQ activities.
- Deviation management and closure
- Guidance and preparation of Quality Risk Assessments for the execution of “enhanced commissioning” strategies. Assessment of commissioning data and preparation of leveraged qualification activities.
- SOP Generation / Revision
- Lead GAP Assessments
- Data Integrity Assessments
- Application of Risk-Based Testing -Vendor Management
- Management of vendors, including the review of vendor testing and application of testing to reduce the validation effort.
- Project Management / Operations Management
- Management of Project Risks, Issues, Changes and Resources
- Timely communication of quality and validation issues.
- Regulatory and Quality Expertise for the application of the following supporting processes including;
- Regulations, Standards and Guidance
- Change Control
- CAPA
- Training and Coaching
- Auditing
- Merge and Acquisition
- Assessment of current system’s status against destination environment standards
- Remediation plan
- Follow up onboarding activities (training, procedures onboarding)
- Quality and Compliance support
- QMS On-boarding
- Remediation Projects
- Gap Assessment/Impact assessment
- Remediation Plan
- Remediation activities follow up/closure
People, Processes and Tools
Roles:
- Validation Manager
- Commissioning, Qualification and Validation Lead
- Commissioning, Qualification and Validation Engineer
- Project Manager
- Test Manager
- Quality Lead
Process:
- Commissioning, Qualification and Validation Projects (CQV)
- CQV Planning and Strategy development
- Validation Program Management
- VMP (Validation Master Plan) Project Planning
- User Requirement Specification (URS)
- GAP Assessment
- cGMP Review
- Design Review
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Design Qualification (DQ)
- Commissioning protocols
- Installation Qualification (IQ)
- Operational Qualification(OQ)
- Performance Qualification (PQ)
- Traceability Matrix
- Risk assessments (FMEA)
- Test and Validation Reports
- Quality Risk Management and Design/Process FMEA
- Process standardisation and continuous improvement
- Change Management
Other Processes
- Technical Transfer (Test Method Validation)
- Process Validation
- Calibration Support, including SOP Generation.
- Cleaning Validation
- Sterilisation Validation
- Computer System Validation (CSV)
- Data Integrity -Instrument and Equipment Data Integrity Assessments – FDA 21 CFR Part 11/Eudralex Annex 11 Assessments.
Quality Management System
- Quality Systems (SOP generation, update and review)
- CAPA
- Training
- Regulatory Assessment
- Vendor management
- Audit
Tools and Technologies (References);
- ASTM E2500 E2500-07 -*Reapproved 2012 –Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- ISPE Baseline Guide Commissioning and Qualification (2nd Edition)
- ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
- ISPE A Risk-Based Approach to GxP Compliant Laboratory Computerized System
- ISO9001: 2015 Quality Management Systems
- ISO13485: 2016 – Medical devices — Quality management systems — Requirements for regulatory purposes
- ISO14971:2019 – Medical devices — Application of risk management to medical devices
- ISO27001:2013 -Information Security Management
- GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems (ISPE)
- 21 CFR 210 – Current Good Manufacturing Practice (CGMP) Regulations
- 21 CFR 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals.
- 21 CFR 600 – Biological Products: General
- 21 CFR Part 11 -Electronic Records, Electronic Signatures
- Eudralex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
- US Pharmacopeia
- European Pharmacopeia
- ICHQ9 – ICH guideline Q9 on quality risk management
Value Delivered
Our multidisciplinary team comprising of Subject Matter Experts in Commissioning, Validation, Manufacturing, Engineering, Quality, Compliance and Regulatory Affairs will work with you and your teams to fully understand your needs at every stage of the project lifecycle, including;
- Planning and defining strategies, acceptance criteria, test methodology, including support from an execution and review perspective.
- The application of the risk-based approach methodology to ensure that lean processes are implemented in a compliant manner, and that patient safety, product quality, data integrity is assured.
- Support the execution and review of Vendor activities, including;
- FAT, SAT execution.
- Test Packs
- Review of the application of GEP
- Vendor Quality System reviews on behalf of the regulated company
- Leveraging of Vendor Documentation
Clients / References
- AbbVie (Allergan) Pharmaceuticals Ireland.
- Charles River Laboratories
- Novartis
- GSK
- Philip Morris International
