General Introductory Training
Our general introductory GMP training courses provide essential understanding for anyone new to pharmaceutical manufacturing or wishing to reinforce their foundational knowledge. At Clarion Quality, we deliver bespoke packages and in-house courses covering a wide range of quality and compliance needs:
Good Manufacturing Practice (GMP) for Pharmaceuticals and Investigational Medicinal Products (IMPs):
We explain the fundamentals of GMP, focusing on its role in regulatory compliance, patient safety, and process consistency. Whether you are developing medicines or producing IMPs for clinical trials, our training ensures your team is equipped with current best practices.
GMP for Pharmaceutical Laboratories:
Laboratory quality is critical to reliable test results and regulatory compliance. We demystify the GMP framework applied to laboratories, addressing the unique challenges of pharmaceutical testing environments and aligning daily practice with current GxP regulations.
Active Substance Manufacture
(GMP Part II):
For those responsible for manufacturing active pharmaceutical ingredients (APIs), we offer tailored sessions on GMP Part II, emphasising the requirements that distinguish API production from finished product manufacture.
Our GMP training for pharmaceutical companies is delivered in a format that allows for interactive discussion, practical examples, and real-world problem-solving. We understand that every site is different, so we personalise our training materials and case studies to the procedures, people, and products of your organisation. This approach builds a deeper understanding and embeds a genuine culture of quality and compliance.
Laboratory Compliance Training
Laboratories play a pivotal role in the pharmaceutical industry's quality chain. Clarion Quality offers pharmaceutical compliance training that addresses the critical requirements set out in ISO/IEC 17025:2017. Our laboratory compliance sessions are crafted for in-house quality control (QC) laboratories and subcontracted laboratories looking to demonstrate competence.
We cover key subjects such as method validation, traceability, impartiality, and risk-based thinking. Our GMP training courses not only explain the standard's technical criteria but also provide advice on continuous improvement and preparing for audits. By partnering with Clarion Quality, you ensure that your laboratory staff are confident and proficient in meeting international expectations.
QMS Training
Our QMS training is structured to guide manufacturing and service industry professionals through the implementation and maintenance of ISO/IEC 9001:2026 requirements. The latest ISO 9001 standard, due for publication in September 2026, emphasises sustainability, ethical leadership, and digital integration.
At Clarion Quality, we equip your teams with practical strategies to identify, apply, and embed these changes within your organisation. Our courses address the transition from previous ISO 9001 versions, highlight the new focus areas such as quality culture and knowledge management, and outline the three-year transition timeline for certified organisations. We deliver engaging, informative sessions, tailored to your operational context, promoting continuous improvement and longevity in your quality management system.
Key Changes in ISO 9001:2026
The 2026 revision of ISO 9001 will introduce a series of refinements to support better organisational outcomes and compliance. Clarion Quality keeps you ahead of regulatory expectations with in-depth guidance on these improvements:
- Leadership and Culture: There is an enhanced emphasis on ethical leadership, accountability, and developing a culture centred on quality at all levels of your organisation.
- Risk and Opportunity Management: Beyond listing risks, there is now a requirement to actively manage and seize opportunities, strengthening proactive quality management.
- Sustainability and Climate Considerations: The new standard requires integration of sustainability and climate-related concerns in your business context.
- Digital Tools and Transformation: ISO 9001:2026 encourages organisations to use digital tools and AI to streamline their QMS processes.
- Knowledge Management: A stronger focus on retaining, sharing, and applying knowledge supports ongoing competence and organisational learning.
- Customer Communication: Clear requirements for communication, including informing customers about contingency planning and transparent quality operations.
- Operations and Supply Chain: Suppliers must now align with stakeholder requirements beyond technical compliance, ensuring a robust supply chain.
- Continual Improvement: There is a much stronger expectation that improvement goes beyond problem-solving, emphasising suitability, adequacy, and effectiveness of your QMS.
Our GMP training courses, including those focused on the new ISO 9001:2026 requirements, set your business on course for a successful transition and ongoing compliance.
Frequently Asked Questions
What types of GMP audits does Clarion Quality provide?
Clarion Quality offers GMP audits, including site inspections, supplier audits, pre-contract placement inspections, and surveillance audits across the UK.
What is included in a pharmaceutical supplier audit?
A pharmaceutical supplier audit checks your supplier’s GMP compliance, quality systems, record-keeping, and risk management to ensure reliable supply chains.
How does a gap analysis audit work?
A gap analysis audit compares your current practices against regulatory and industry standards, identifying areas to improve compliance and recommending action.
How can an audit help prepare for regulatory inspections?
A Clarion Quality audit uncovers compliance gaps and offers actionable feedback so organisations can meet regulatory expectations and be ready for inspections.
Do you conduct audits for clinical trial facilities?
Yes, we provide clinical trial audit services, including audits of importation hubs and related logistics, ensuring GCP and GMP compliance for clinical trial facilities.
What should organisations expect during a GMP audit?
During a GMP audit, Clarion Quality's auditors review procedures, documentation, and practices, offering transparent, supportive guidance and follow-up recommendations.
Arrange Your On-Site Training
Ready to advance your organisation's quality culture with Clarion Quality's GMP training courses? For engaging, informative pharmaceutical industry quality training to suit your site and team, contact us today.
Services
Clarion Quality GXP UK Limited - Company number 12675976 - Registered in England & Wales