Equipment Qualification and pharmaceutical compliance
It is a structured process that accompanies the equipment from its design to its routine use, ensuring that it works correctly and safely for the product.
In the pharmaceutical industry, equipment qualification is not only a regulatory requirement, but also an opportunity to optimize processes, reduce risks and gain agility.
Do you know the qualification life cycle well?
- URS (User Requirements Specification)
- DQ (Design Qualification)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- Periodic review and re-qualification
Tips and tricks
- Use smart and modular templates: save time without losing traceability.
- It applies a Risk-Based Approach from the URS.
- Integrate supplier testing to avoid duplication in IQ/OQ.
- Digitize document tracking and signing: more control, less paper.
- Standardize processes across similar equipment to minimize repeated validations.
Why Rephine?
✅ Proven technical expertise: We have years of experience in executing qualifications in GMP environments, both in laboratories and pharmaceutical production plants.
✅ Efficient and compliant methodology: We apply a Risk-Based Approach, adapted to the latest regulatory guidelines (Annex 15), optimising the balance between compliance and agility.
✅ Reduction of document workload without compromising quality: We design intelligent, modular and reusable documentation strategies that reduce the volume of documents by up to 40%, while maintaining the traceability and robustness of the data.
✅ Close collaboration with costumer: We work closely with the quality, validation and engineering departments, adapting to your operations and providing real solutions to your needs.
✅ Results that generate value from day one: Our ability to combine efficiency, compliance and practicality makes us a strategic partner to tackle any qualification project in a comprehensive manner and with guarantees.
Real-World Success: Case Study
A recent example managed was the qualification of several critical equipment in an Active Pharmaceutical Ingredient (API) plant with tight deadlines. By applying a risk-based approach from the URS phase, integrating supplier testing into the IQ/OQ stages and using modular documentation, it was possible to reduce the volume of documentation by 35% and shorten execution times by 25%. The project was completed without deviations and successfully passed an internal audit without observations. This experience demonstrates that, with the right approach, it is possible to qualify in an efficient, agile and fully compliant manner.
Streamlining Equipment Qualification: A Rephine Case Study
One of our recent projects involved supporting a global pharmaceutical manufacturer during the qualification of complex, interdependent systems for thyroid API production. Faced with legacy equipment, tight timelines, and high compliance stakes, Rephine delivered a risk-based qualification approach that integrated supplier testing, modular documentation, and cross-functional collaboration.
✅ The outcome:
- 35% reduction in documentation volume
- 25% faster execution time
- Successful audit with zero observations
- A scalable qualification model for future revalidations
📄 Read the full case study to see how Rephine enabled faster manufacturing restart with full GMP compliance.
Final Thoughts
Equipment qualification is a critical process in the pharmaceutical industry that, when approached strategically, can be much more than just a regulatory requirement. Through practical approaches, efficient tools and the integration of best practices, it is possible to optimise time, reduce documentation burdens and ensure that all equipment is functioning properly, without sacrificing compliance.
At Rephine, we understand that every project is unique, and our experience shows that it is possible to improve both efficiency and quality throughout the qualification lifecycle. If you are looking to optimise this process in your organisation, please do not hesitate to contact us to explore how we can help you implement solutions that make a difference.
Need to start your equipment qualification processes in your Company? Contact us at [email protected]