Compliance for Investigational Medicinal Products (IMPs)
Our in-depth understanding of the pharmaceutical industry regulations supports every phase of clinical trial management. Our IMP compliance services include:
Gap Analysis and Pre-Assessment
We identify gaps in current laboratory quality systems compared to GLP and ISO 17025 standards, delivering clear action plans for improvement.
Accreditation Support
Our team helps you prepare all required evidence, documentation, and laboratory protocols to ensure a smooth accreditation process, minimising delays and nonconformities.
Ongoing Regulatory Guidance
We offer ongoing advisory support to keep laboratories compliant with international pharmaceutical industry regulations, helping you adapt to regulatory changes smoothly.
ISO 17025 Laboratory Consultancy
Our expert guidance extends to technical and managerial aspects of laboratory operation, ensuring all aspects of testing and calibration are covered.
Alignment with Global Standards
Clarion Quality's knowledge addresses not just UK regulations but also international expectations, future-proofing your compliance strategies.
Laboratory Auditing and Quality Consultancy
Regular auditing ensures laboratory quality management systems stay up to date and effective. Clarion Quality delivers thorough, expert-led audits for pharmaceutical laboratories, including:
Internal Auditing
Comprehensive audits of laboratory processes, data integrity, and documentation to identify weaknesses and recommend corrective actions.
Supplier Auditing
Independent assessments of your third-party suppliers, ensuring they meet your laboratory's rigorous quality standards and contributing to reliable service chains.
Corrective and Preventive Action (CAPA)
We work collaboratively to develop, implement, and review effective CAPA processes, supporting ongoing compliance.
Continuous Improvement
Our approach highlights opportunities for process optimisation and risk reduction, leading to improved laboratory efficiency and standards.
Staff Training for Laboratory Quality Systems
Ensuring laboratory staff are equipped with the necessary skills and understanding is vital for maintaining high standards in laboratory compliance. Clarion Quality's staff development programmes include:
- Workshop Delivery: We conduct focused training sessions covering quality management, regulatory expectations, and laboratory best practice, tailored to your specific operational needs.
- Role-Specific Training: Training is adapted for laboratory managers, technicians, and analysts, making sure every individual fully understands their compliance responsibilities.
- Ongoing Mentoring and Support: Post-training, we provide continued mentorship, offering advice and updates on evolving pharmaceutical industry regulations.
- Practical Assessments: Knowledge checks and hands-on assessments reinforce learning outcomes and compliance confidence amongst laboratory teams.
- Building a Quality Culture: Our training fosters a culture of responsibility, engagement, and compliance that underpins laboratory success.
Laboratory Quality Documentation and Processes
Documentation is the backbone of pharmaceutical laboratory compliance. Clarion Quality assists UK laboratories by:
- Standard Operating Procedures (SOPs): Reviewing, writing, and updating your laboratory SOPs to maintain clarity, accuracy, and compliance with ISO 17025 and GLP standards.
- Document Control Systems: Implementing and optimising electronic or paper-based quality control processes, ensuring all records are traceable, confidential, and accessible.
- Record Management: Advising on best practices for data integrity, sampling records, calibration logs, and traceability in accordance with international requirements.
- Process Mapping: Analysing laboratory workflows to uncover inefficiencies and implement process improvements with a compliance focus.
- Audit Trail Support: Setting up robust audit trails to ensure laboratory documentation is reliable and fully supports accreditation and inspection requirements.
Frequently Asked Questions
What is ISO 17025 and who needs it?
ISO 17025 is an international standard for testing and calibration laboratories. Any laboratory wanting to prove technical competence, ensure quality, and gain accreditation, especially in the pharmaceutical industry, should comply with ISO 17025.
How can laboratories achieve ISO 17025 accreditation?
Laboratories achieve ISO 17025 accreditation by implementing a robust quality management system, aligning procedures with the standard, documenting processes, and undergoing successful audits by accreditation bodies such as UKAS. Consultancy support makes the process smoother and more effective.
What is involved in implementing a laboratory quality management system?
Implementing a laboratory quality management system involves developing and maintaining Standard Operating Procedures (SOPs), ensuring documentation controls, training staff, applying regulatory requirements, and routinely auditing processes to foster continuous improvement and compliance.
How can laboratories prepare for a UKAS audit?
Preparation includes a thorough gap analysis, addressing nonconformities, documenting evidence of compliance, running internal audits, and staff training. Engaging laboratory compliance consultants can help ensure systems and documentation meet UKAS requirements.
What are the benefits of ISO 17025 accreditation?
ISO 17025 accreditation demonstrates technical competence, improves laboratory credibility, increases customer trust, opens access to new markets, and ensures compliance with international pharmaceutical industry regulations.
Do pharmaceutical laboratories need to comply with GMP as well as ISO 17025?
Yes, pharmaceutical laboratories often need to comply with both GMP and ISO 17025. GMP focuses on manufacturing practices, while ISO 17025 is specific to the quality of testing and calibration activities. Compliance with both ensures complete quality assurance.
Enhance Your Laboratory's Compliance Today
Discover how Clarion Quality's expert laboratory compliance consultants can help you meet and maintain pharmaceutical laboratory compliance and ISO 17025 standards in the UK. Whether you need auditing, documentation support, or staff training, we provide specialist, helpful guidance shaped by thirty years of experience.
Services
Clarion Quality GXP UK Limited - Company number 12675976 - Registered in England & Wales