Validation isn’t just a one-time event. In the pharmaceutical industry, regulations require ongoing oversight to make sure systems, processes, and analytical methods stay effective and compliant. This is where Periodic Validation Reviews (PVR) come into play.
By regularly checking up on these systems, Periodic Validation Reviews help keep them in top shape, using risk analysis, teamwork across departments, and the latest technologies to keep up with the industry’s fast pace.
For example, guidelines like USFDA Q7A and ICH Q7 highlight the need for periodic validation reviews: “Systems and processes should be periodically evaluated to verify that they are still operating in a valid manner.” The tricky part? They don’t provide much detail on how to actually do this.
In this article, we’ll break down the steps for conducting effective periodic reviews, showing how new tools and approaches can simplify the process and ensure everything stays compliant with the latest regulations.
What’s the Goal of a Periodic Validation Review?
At its core, a Periodic Validation Review (PVR) is all about making sure your processes still work safely and effectively over time. This means having a solid plan to review the systems and processes that drive your manufacturing. But it’s not just about the processes—you also need to evaluate any qualified equipment and validated IT systems involved.
The review plan is usually built on a risk analysis. Why? Because risk analysis helps you prioritize which systems need attention first and how often you should review them. For example:
Risk Level | Frequency of Review |
|---|---|
Low | 5 years |
Medium | 3 years |
High | 1 year |
Table 1: Recommended review frequencies
Several factors feed into this risk analysis, such as how critical the process is, key product quality attributes, and the frequency of GMP data review. Whether it’s your manufacturing process, lab test methods, computer systems, or cleaning procedures, they all need regular checkups.
Who’s Involved in Periodic Validation Reviews?
Once you’ve determined the frequency of your periodic validation reviews, it’s time to bring together the right team to carry them out. Different departments play key roles, and their involvement can vary depending on your organization’s size.
Typically, you’ll see Validation/Technical Services, Engineering, Production, IT, and Quality Assurance (QA) teams stepping in to help, with QA often taking the lead on coordinating the entire periodic validation review process.
Here’s an example of how responsibilities might break down:
Department | Responsibilities |
|---|---|
Validations/Technical Services | Status planning and maintenance, risk assessment, review performance, report approval |
Engineering and Production | Risk assessment, review performance |
IT | Risk assessment, review performance |
QA | Status planning, review performance, report approval |
Table 2: Example of responsibilities of departments involved in the periodic review.
Of course, depending on the system or process under review, you might also have other teams jump in, like Quality Control (QC), the Change Advisory Board (CAB), or system owners.
PVR vs. Revalidation/Requalification: What’s the Difference?
Wondering how periodic validation reviews differ from revalidation or requalification? Here’s the main distinction: a periodic validation review is like a regular checkup to ensure systems are still validated. Revalidation, meanwhile, involves testing to confirm a system still meets required specifications.
During a periodic review, you’re mostly reviewing documentation and changes, not running tests. Revalidation, on the other hand, requires hands-on testing based on specific protocols. So while both processes aim to maintain compliance, they take different approaches.
What Do You Review During a Periodic Validation Review?
When conducting a periodic validation review, key elements to examine include:
- A full description of the system, including critical subsystems or components.
- A review of any changes made to the system or process.
- Deviations related to the system or process.
- Maintenance and calibration records for any equipment or instruments involved.
- A check of KPIs (Key Performance Indicators).
- Any changes to regulatory requirements, GMP, or site procedures since the last review.
Thankfully, there are plenty of tools out there to help gather and analyze the data you need for a thorough periodic validation review. Let’s look at a few of them:
- Risk management software: Helps identify, manage, and reduce risks.
- Automated real-time monitoring tools: Keep tabs on system performance and provide up-to-the-minute reports.
- Change control tools: Ensure any system changes are properly documented, reviewed, and approved.
- Data analysis tools: Make it easier to spot trends, anomalies, or problem areas in large datasets.
Wrapping It Up: What’s in the Periodic Validation Review Report?
Once you’ve completed your periodic validation review, it’s time to document everything in a report. This report should include:
- A review of all relevant documentation to ensure it matches the current state.
- Recommendations for revalidation or requalification, if needed.
- Suggestions for continuous improvement.
- A follow-up on any corrective or preventive actions (CAPA) that were applied.
- An assessment of whether the frequency of reviews needs adjusting based on the results.
The report needs to be reviewed and approved by all the key departments involved, with the final sign-off usually coming from QA.
Conclusion: Setting the Stage for Success with PVRs
To ensure the validated state of systems and processes is maintained, several key factors come into play:
Multidisciplinary collaboration
A successful periodic review requires the input of various departments—Quality Assurance, Regulatory Affairs, IT, CAB, Operations, and more. By fostering collaboration, each team can contribute its expertise, leading to a more comprehensive evaluation and better problem-solving across the board.
Risk-based approach
Prioritizing resources through a risk-based lens ensures that the areas with the highest impact on product quality, patient safety, and regulatory compliance get the attention they need. Tailoring your review frequency based on risk levels is a smart way to stay proactive and compliant.
Clear documentation and procedures
Well-defined processes are at the heart of a successful periodic review. Proper documentation of review plans, methodologies, and responsibilities ensures consistency, transparency, and accountability throughout the process.
Use of technology
Leveraging electronic systems, automated tools, and data analysis solutions transforms the review process. Real-time monitoring tools provide instant feedback, while predictive software helps anticipate potential issues before they arise. These advancements allow organizations to shift from a reactive model to a more preventive and continuous approach, making it easier to meet changing regulatory demands and industry best practices.
By integrating new technologies and risk-based planning, the industry is steadily moving away from a reactive, stop-and-go approach to validation and embracing a proactive, continuous model.
This evolution allows companies to respond faster to regulatory changes, industry innovations, and organizational needs, all while driving consistent improvement in quality processes.
Figure 1: Periodic Review steps.
At QbD Group, we specialize in helping pharmaceutical companies navigate the complexities of validation and compliance.
With our multidisciplinary team, cutting-edge tools, and risk-based strategies, we ensure your systems remain validated, compliant, and ready for the future.
Let QbD Group help you streamline your periodic reviews and ensure your systems are future-ready.
- PVR: Periodic Validation Review.
- ICH: International Council of Harmonisation
- FDA: Food and Drug Administration.
- QA: Quality Assurance.
- QC: Quality Control.
- CAB: Change Advisory Board.
- IT: Information Technology.
- CAB: Change Advisory.
- CAPA: Corrective Actions Preventive Actions.
- KPI: Key Performance Indicators.
- GMP: Good Manufacturing Practices.
- Guidance for Industry, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
- ICH Q7 Good manufacturing practice for active pharmaceutical ingredients Step 5- Scientific guideline
- Annex 11: Computerised Systems, EU Guide to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use.
- Annex 15: Qualification and Validation, Guide to EU GMP, Medicinal Products for Human and Veterinary Use.
- PIC/S PS/INF: Guide to Good Manufacturing Practice for Medicinal Products Annexes, Annex 15.
- ICH Q14, Analytical Procedure Development.
- ICH Q2(R2): Validation of Analytical Procedures.
- Multi-annual AI workplan 2023-2028 HMA-EMA Big Data Steering Group.
- Generative AI in the pharmaceutical industry: Moving from hype to reality. McKinsey & Company.