Product contamination due to insufficient cleaning processes is a frequent cause for FDA Form 483 observations and costly and embarrassing recalls. It’s easy to see why. When designing and implementing an effective cleaning validation program, there are many things to consider. Planning is critical. But too often, pharmaceutical manufacturers develop protocols to establish a program quickly without identifying the appropriate pre-requisites, such as selecting a worst-case product for each equipment/cleaning combination. These pre-requisites must be identified, verified, and documented before you can execute any cleaning validation activity or protocol.
Developing and implementing an effective cleaning validation program is complex but maintaining it is equally difficult. Change is constant. Every time you introduce a new product or piece of equipment or change a cleaning procedure or formulation, you must assess the impact of that change with a cleanability impact assessment. Maintaining changes and evaluating the risk associated with those changes on paper using manual processes is highly challenging.
Today’s post will examine some common pain points that can be alleviated or even eliminated through digitized and automated cleaning validation processes. For a deeper dive into how digitization helps ensure your cleaning validation program is efficient, safe, and compliant, download our complimentary webinar.
Pain Point: Absences of pre-approved validation plan or strategy
As noted above, embarking on a cleaning validation program without a clear strategy is a recipe for disaster. Even if you take the time to put a comprehensive plan together, documenting it on paper leaves you vulnerable to human error and increased risk. Paper is easy to lose or misplace. The time required to correct mistakes and recreate documents can cause time-to-market delays. To ensure your efforts are not in vain, consider implementing a cleaning validation software solution.
The ValGenesis system can digitally replicate your existing paper-based cleaning validation program according to your own SOPs and corporate quality policy to eliminate human error and enforce consistency. The system easily automates key stage one activities, including the collection of equipment design and construction information, the establishment of product contact and non-product contact surfaces, analytical method development for products and cleaning agents, and the creation of the cleaning validation master plan. Automating these activities with technical controls rather than manual procedures eliminates many of the inefficiencies and discrepancies associated with traditional paper-based cleaning validation.
Pain Point: Inconsistent, inaccessible cleaning documentation
During the cleaning validation lifecycle, you generate a significant amount of data. In a paper-based system, this data is either archived in an on-site repository or an off-site storage facility. This means critical documentation is not readily available to present to auditors, and audit trails are poor. Related calculations, such as maximum safe surface residue and worst-case product, are managed in Excel spreadsheets or Word documents, which are not easily accessible and subject to data integrity issues. Basic questions can’t be answered, and compliance is at risk.
With ValGenesis, access to the entire cleaning validation lifecycle is at your fingertips. Because it’s FDA 21 CFR Part 11 compliant, the ValGenesis cleaning validation solution automatically generates complete, compliant audit trails with version and user-access control. Our system aligns with ICH-Q9 principles for managing risk.
Consistency is critical in cleaning validation but virtually impossible to achieve without digitizing. Paper-validation processes rely solely on individuals who hold to their own ways of doing things, so tasks are approached and documented in many ways—there’s no standardization.
ValGenesis allows you to create business rules in configurable templates based on your SOPs and requirements. Setting business rules is a one-time activity. Once configured, the system instantly, in one click, identifies the worst-case product/equipment at the product/equipment family level or the entire product/equipment portfolio level—consistently and accurately. The system then notifies the user of the next steps, e.g., what deliverables and activities are needed, based on the validation framework.
Properly configured digitized cleaning validation ensures consistent output, including product family, equipment grouping, dirty and clean hold times, calculation of surface area matrices, and MACO calculations.
Pain Point: Vague Analytical Methods in use
A well-developed cleaning validation strategy includes analytical method validation, which defines the method parameters necessary to provide a high level of confidence in cleaning results. The pain point: how do you ensure that your analytical methods are quantifiable when establishing your acceptance criteria? Often, the R&D team develops the analytical method. But they may not have any visibility into how, for example, residual limit calculations are being established, and things can fall through the cracks.
Limit of detection (LOD) and limit of quantitation (LOQ) values are fully integrated into the ValGenesis application. When you calculate the residual limit based on your formula (however you configured it in the system), the system flags out-of-limit values as not analytically supported when the value is lower than the LOD and LOQ. Digitization ensures that your methods, procedures, and SOPs are risk-based and rooted in scientific evidence.
- Digitization offers a consistent way to carry out cleaning validation lifecycle activities.
- The ValGenesis cleaning validation software solution can replicate your current cleaning validation process while removing the human error and inefficiency associated with paper-based methods.
- Digitization helps you control risk.
- Maintaining a compliant cleaning validation program requires non-stop vigilance because change is constant. Digitization streamlines the cleanability impact assessment process, letting you know exactly what you need to do to make, approve, and implement the change.
What are your most significant cleaning validation pain points? Let us know in the comments below. Watch the webinar and read the tip sheet to learn more about digitizing your cleaning validation process.