Navigating Equipment Requalification In Pharma
Since the new version of Annex 15 came into operation during 2015, pharmaceutical companies should requalify their equipment, utilities, facilities and systems on a periodic basis.
How Not To Drown In A Sea of Elements To Requalify
The problem arises when those companies try to conduct the requalification of all their elements and find out that they do not have the capacity to perform this activities in an efficient manner because there are many elements to requalify.
A Risk-Based Approach To Equipment Requalification
To face this challenge, it is essential to perform the following key activities to success:
- Stablish requalification policy to define the scope and methodology
- Perform a risk assessment to determine which elements are more critical than others.
- Critical elements should be more often requalified than less critical elements.
- Prepare a requalification protocol, to check the correct qualification status of each element.
With this approach, pharmaceutical companies can prioritize their efforts within requalification activities making it easier to plan activities and resources.
How Rephine Supports Effective Requalification
Rephine counts with equipment, utilities, facilities and systems experts that has the knowledge to conduct an adequate assessment in each of their own fields with accepted methodology either by customers and regulatory authorities.
The requalification protocols should not only consist in documental review like deviation/change control status, but also, ensuring that elements in place remain the same as initially characterized. Also, operational testing should be carried out, however, full functionality should be tested at some point during the requalification process.
Our Requalification Services
Our services include but not limited to:
✅ Preparing the requalification policy and risk assessment definition.
✅ Performing the risk assessment for each piece of equipment, utility, facility of system.
✅ Preparing the requalification protocol according to regulatory authorities expectations.
✅ Conduction of requalification activities by the best experts in each of the fields.
Case Study: Streamlining Requalification Across Multiple Sites
Upon many customers, on of the most notorious case is an international API manufacturing customer that faced the difficulty on applying requalification activities to several manufacturing sites, each one of them with their own particularities, products and workshops.
Rephine helped them into stablishing an adequate requalification policy, that made it easier for them to organize priorities and define which elements are more critical than others and implementing a proper requalification methodology that could be implemented alongside all the customers sites.
Streamlining Equipment Requalification: A Rephine Case Study
In this case study, Rephine supported a global pharmaceutical company in developing and deploying a scalable, risk-based equipment requalification strategy across multiple manufacturing sites. Starting with two complex facilities in Spain, the client faced inconsistent practices, no central policy, and limited internal expertise.
Rephine delivered a fully structured approach—aligning with Annex 15—by defining requalification policy, performing site-specific risk assessments, and standardising protocols to accelerate global rollout.
✅ The outcome:
- Defined requalification frequencies based on equipment criticality
- Reduced time spent on low-risk asset requalification
- Increased audit readiness and regulatory alignment
- Faster implementation at additional sites through standardisation
📄 Read the full case study to see how Rephine turned a complex requalification challenge into a compliant, efficient, and scalable solution.
Final Thoughts
Performing requalification activities can be extremely resource/time demanding if not faced correctly. With Rephine’s expertise, high area experienced staff and direct contact with regulatory authorities, companies can face the requalification on a fit-to-purpose basis and according to what it is expected by auditors.
Ready To Optimise Your Requalification Process?
Need to start your requalification processes in your Company? Contact us at [email protected] or visit our website www.rephine.com to learn more.