Current regulations require that manufacturing processes in the pharmaceutical industry be validated, and once validated, they must be continuously monitored to demonstrate that they remain under control, resulting in a quality product. This monitoring must be maintained throughout the life cycle of the product to ensure quality as intended in the product design.
It should be clear that validation is never really finished, the activities simply change from Process Design and Process Qualification to the Continuous Process Verification phase. Have you validated your computerized system(s) yet? Then CSV periodic reviews are an important next step.
In this post, we are going to explain:
- what a CSV periodic review is,
- what its purpose is,
- and how often you should perform them.
We will also talk about the process to follow, and the minimum documentation needed to perform a risk-based periodic review of your validated systems.Â
What is a ‘Periodic Review’ in CSV?
A Periodic Review is an assessment of various elements to determine the validation status and the actions required to maintain the validated state of systems or equipment, through which we will demonstrate and ensure that they remain fit for their intended use.
What do we mean by ‘Maintenance of Validated Status’?
To maintain a validated state, companies must take all steps to document and analyze changes, errors, or malfunctions in a system or equipment to determine if it still fits the purpose and process it serves.
‘Maintaining validated status’ includes continuously demonstrating via review of process data, change control, deviations, corrective and preventive actions, and other related activities, that the manufacturing process remains under control and results in a product that ensures quality and patient safety.
A complete guide to Computer System Validation
This +100 page guide aims to bring context and define the necessary and appropriate strategies for the validation of computerized systems for Pharmaceutical Industries, Biologics, Biotechnology, Blood Products, Medicinal Products, and Medical Devices, used in activities related to compliance with Good Practices (GxP). Download it now for free:
FREE E-BOOK
What is the purpose of CSV Periodic Reviews?
The purpose of a periodic review is to confirm that systems are maintained in a validated state and comply with all applicable standards and procedures throughout their operational life cycle.
Frequency of CSV Periodic Reviews
Depending on the GxP impact of your system, the frequency of the periodic review should be determined. The minimum recommended frequency is once a year after the system or equipment is released for productive use.
The most common elements to consider during a CSV periodic review
The most common elements to consider during a Periodic Review are:
- The previous periodic review report, as well as actions and recommendations made.
- System change history
- Maintenance records, calibration records, and system usage logs
- Documentation, which includes procedures, current user training records, validation documents, and system life cycle documents
- Updated system user matrix, along with user training matrix
- Quality records, such as deviations, CAPAS, audits, change records, etc.
- System Audit Trail
- System performance
CSV Periodic Review Process
In general, the process you choose to conduct CSV Periodic Reviews should be outlined in a standard operating procedure (SOP) with templates needed to conduct the evaluation.
Figure 1 – GAMP 5 ‘A Risk-Based Approach to Compliant GxP Computerized Systems’, 2008.
Considerations
Finally, it is important to keep these considerations in mind regarding CSV Periodic Reviews:
- The periodic review process should be general and applicable to all systems. It should apply to operational environments and not to development or support testing environments. The depth and rigor of the review should be based on the impact, complexity and newness of the system or the nature of an incident or event that triggers a review.
- Where appropriate, the Periodic Review of the IT system may be conducted as part of a broader activity, such as the Periodic Review of a production process.
- Periodic Reviews should take into account and refer to other appropriate reviews, such as the review of safety records, and should not duplicate activities.
- It may be useful to develop checklists for Periodic Reviews that are specific to particular systems.
- A process for timing and scheduling reviews should be established. Review periods for specific systems should be based on the impact, complexity, and newness of the system.
- Whatever method is chosen, the process should be documented and approved by the management of the regulated company, and the responsibility and decision criteria should be clearly defined. Responsibility for managing the planning and programming process and allocating resources for revisions must also be clearly defined.
Need help?
Do you need help with the preparation of your SOP and templates for the Periodic Review of your systems? Or would you rather have expert support you in the complete process of periodic reviews of all your GxP systems? QbD Group is happy to help you out! Please do not hesitate to contact us.
