CSL facilitated the most recent benchmarking session of AMP with nine peer pharmaceutical companies in September 2025. Prior to the session, CSL received interest in discussing calibration management.
The conversations were held over two hours of collaborative discussion and knowledge sharing. There was a very open and transparent exchange of information by all participants. Some participants chose to present on their company’s success or challenges with the topic and all were highly engaged for the open discussion and Q&A portions.
While each participating company was reflecting on its own unique journey, the following topics stood out as highlights from the benchmarking sessions:
- Structure of Calibration Management Systems
- One of the key topics of conversation was around the structure of the calibration management systems that the sites use. Universally, this was linked to the companies’ maintenance management system, as a sub-program underneath it.
- Each company’s programs were governed by a documentation structure, with the majority of the companies having some type of global standard for the program in place
- Defining instrument criticality was discussed as one of the key considerations for implementation of a calibration management program. Companies varied in their approach to criticality.
- Even though calibration management is something that can be closely tied to regulations, there were still a number of areas where the companies differed in aspects of their programs:
- Deviation Management
- Single Point Calibration
- Some companies have made strides with Single Point Calibration in non-good manufacturing practices (GMP) environments, while others still receive pushback from their internal quality assurance and have not been able to implement any single point calibration schemes
- Transition Toward Condition-Based Calibration
- There is an industry wide trend or desire to moving toward leveraging smart instruments with built-in self-verification capabilities and move away from traditional time-based calibration schedules
- Some of the options discussed include: Endress + Hauser Heartbeat and TrustSense and Emerson Smart Meters
- Each of these has different features but the overall goal is the same: Enable calibration to be done as needed instead of time based through use of instrument self-monitoring
- Considerations for implementation of Condition-Based Calibration
- Develop a structured governance model that includes:
- Defined frequency for data collection
- Clear ownership of monitoring and response
- Integration with maintenance systems (e.g., OSI PI, Seeq, SAP)
- Launch pilot programs:
- Used to validate the effectiveness of the new technology in detecting drift and triggering appropriate actions
- Implemented at one site then use findings to leverage at other sites
- Start in low-risk applications
- Non-GMP areas are easier to get buy-in from local quality teams
- Benefits of Condition-Based Calibration
- Increased efficiency by reducing unnecessary calibrations
- Real-time drift detection, improving reliability and responsiveness
- Reduced regulatory burden if systems are validated and governed properly
- Scalability across networks once proven and standardized
- o Challenges
- Quality team buy-in is essential; regulatory acceptance hinges on robust documentation and validation.
- Some vendors may not share internal algorithms, complicating validation.
- Condition-based calibration must fit within broader asset management frameworks (e.g., reliability-centered maintenance (RCM), shutdown schedules). If the interval is eliminated or extended, but results in failures that cause stoppages outside of shutdown windows, was the benefit properly assessed?
- Instruments trigger notifications before reaching failure thresholds, but procedures must define how these are managed and documented.
- Calibration Optimization
- Aside from the use of smart technology, there were data driven examples of when calibration intervals could be extended or eliminated.
- One company shared 3 specific examples of success stories with using data to optimize their calibrations.
- Load cell optimization: Using flow meter readings to detect drift over time in the load cells of a vessel, by measuring how much fluid has been pumped into the tank and analyzing it using software to compare it to the load cells
- This allows for real time verification during every production cycle and removes blind spots between calibrations
- Goal: Extend calibration interval
- Interval extension using Weibull Analysis: Using statistical analysis of calibration records over a fixed year period to assess optimal calibration intervals and instrument reliability
- This allows for data-driven decision making for interval setting, reduced calibration workload without compromising integrity, and evidence-based risk management.
- Goal: Extend calibration interval
- Eliminating second calibration step: Using data analysis to prove there is no significant difference in calibration of load cells after flex hoses are swapped on the tank
- This allows for reduction in man hours, reduction in water-for-injectables (WFI) usage, removal of unnecessary steps, and optimization by elimination instead of substitution.
- Goal: Eliminate redundant work
- Most of the applications in the case studies were in non-GMP environments where the risk is lower and regulations are less complex. In time, the benefits captured in the non-GMP space may be transferred into GMP spaces.
All participating companies were keen to continue the discussions on a semiannual or annual basis. CSL has agreed to continue to facilitate these discussions, with the next session targeted for March/April 2026. Any individuals or companies who are interested in participating or have a topic idea to suggest for a future session are welcome to send an email to communities@ispe.org.
