HunterLab’s EasyMatch QC-ER (Electronic Records) software is typically purchased by pharmaceutical companies to meet FDA 21 CFR Part 11 requirements for measuring the color of transparent and translucent liquids, translucent creams, powders, pressed plaques, round tablets, oval caplets and capsules as well as packaging materials.
With this software HunterLab supplies a Validation and Compliance Notebook that implements IQOQPQ protocols as follows:
IQ – Installation Qualification defines a protocol by which a HunterLab instrument is set up and turned on; software is installed on a PC as needed and both hardware and software elements verified to be working correctly together by completing a successful instrument standardization.
Following the Validation and Compliance Notebook, IQ consists of the following three elements:
- Procedure 1 – Installation of Hardware for all sensors sensor to the point such that the instrument is powered up and ready. Connect the sensor communication cable to the PC.
- Procedure 2 – Installation of EZMQC-ER Software for All Systems.
- EasyMatch QC-ER is successfully opened and the sensor loaded. When the sensor beeps or responds, power and communications between software and sensor have been established. Proceed to standardize the instrument. When successful, IQ Installation Qualification has been achieved.
OQ – Operation Qualification defines a protocol in which the sensor diagnostics tests are run and verified to PASS indicating that the instrument is operating correctly to manufacturer’s tolerances.
- Procedure 3 – Checking Wavelength Accuracy verification on the Didymium Filter for sphere instruments only.
- Procedure 4 – Checking Short Term Repeatability on a White Tile for all sensors.
- Procedure 5 – Checking Mid-Range Performance or Long Term Repeatability on the Green Tile for all sensors.
PQ – Performance Qualification defines measurement protocols for each of the customer’s samples based on best practices. This is designed to provide a repeatable measurement and separate good and bad color quality products. This is individual to the customer but can include such products as tablets, caplets, capsules, liquids, powders and semi-solid creams. It should be documented in the customer’s SOP (Standard Operating Procedure).
FAQ: “Do we have a good explanation for customers as to why our PQ Performance Qualification section of the EasyMatch QC-ER Validation and Compliance Notebook only has “suggestions” for the customer? Customers just assume PQ is performance qualification of the instrument and we should have a sign off dedicated to it.”
The simple answer is that it is not possible to write a single, fixed PQ protocol with sign-off for all customers
The EZMQC-ER Validation and Compliance Notebook provides a IQ Protocol for installing hardware and software, then moves on to verify instrument performance using built-in diagnostic tests.
Performance Qualification goes beyond instrument performance to include the use of color instrument to measure a customer’s sample.
Many instruments measure only one attribute and report a single number. Think of making a weighing on a scale where the only choice is to report in metric of American standard units. It is relatively easy to write up a Performance Qualification for any single sample you would weigh.
Color measurement is not that limited. HunterLab instruments measure any color of any product that is in turn related to product quality as defined by the user. It is not possible to write a single measurement method for all applications for all users.
Instead we picked 4 typical pharma applications – round tablets, loose powders, translucent creams and transparent liquids and provided sample methods as well as a protocol to show how to verify the method is repeatable. HunterLab has a further listing of more measurement methods that a customer can use as guides.
For PQ Performance Qualification, it is best for the customer to write their own SOP (Standard Operating Protocol) that incorporates our method suggestions but is specific to their product, including details of how to prepare and present the sample for color measurement, set up software for to report the appropriate color metrics and a how-to method. Screen
FAQ: “How can we satisfy customer’s requirement for DQ? I know they want to measure white API powders. What other input do we need from customer to provide a DQ document?”
In terms of the use of EasyMatch QC-ER software with HunterLab sensors, Design Qualification is a review and documentation that the functional and operational specifications of our instrument and software meet the intended purpose of secure data records in keeping with the principles of FDA CFR Part 11. This is typically done by the vendor but can also be reviewed by the user.
- In Attachment 1 – 21 CFR Part 11 Compliance Table, items in CFR Part 11 related to electronic records and our equipment are listed, along with how they have been implemented through procedural or technical solutions.
- In 21 CFR Part 11 Implementation of EZMQC-ER (pages 17 – 24), descriptions are provided on how these items are implemented in the feature design of our EZMQC-ER software and sensor, along with use of features in the Microsoft operating system.
FAQ: “What is RQ? This came up in conversation with a pharma client and I wondered how this is implemented in EasyMatch QC-ER?”
RQ Requalification, sometimes called MQ Maintenance Qualification, occurs at periodic intervals after you have begun making color quality measurements of your product.
- In EZMQC-ER Validation and Compliance Notebook there is a section entitled “System Validation” that details how to periodically test the security features of Windows as well as the security of data records within EasyMatch QC-ER.
- The diagnostic tests for the instrument will be run on a regular basis and the results documented, affirming operational performance of the instrument meets manufacturer’s specifications over time.
- If you are using a PQ check daily on a stable material such as an APHA/Pt-Co or EP liquid color standard, or a color tile, documentation of these results also supports long term performance of the instrument in measuring the application.