Building an Audit-Ready Impact Testing Workflow for GMP and ISO 11607 Labs

Building an Audit-Ready Impact Testing Workflow for GMP and ISO 11607 Labs

Laboratories operating under GMP or ISO 11607 requirements must treat packaging tests as part of a controlled quality system. Dart impact testing is no exception. To withstand regulatory and customer audits, the entire workflow—from method selection to data storage—must be documented, controlled, and traceable.

The first building block is a clear test method description. This should identify the relevant standard (such as ASTM D1709 or ISO 7765-1), specify Method A or B, define sample types and conditioning, and describe the staircase procedure in detail. Any deviations from the standard, such as alternative conditioning temperatures to match product use, should be justified and documented. The method description is often captured in a written SOP that is approved and version-controlled.

Next, equipment control is critical. Impact testers should be uniquely identified, regularly maintained, and verified or calibrated. Verification may include checking drop heights, inspecting dart geometry, confirming weight accuracy, and verifying that clamping pressure and release mechanisms function as intended. Records of these checks, including dates and responsible personnel, should be kept for audit purposes.

Data integrity is another focus area. Test systems should record the key parameters for each run: sample ID, batch number, method, environmental conditions (if available), starting dart mass, increment size, pass/fail sequence, and final M50. If the instrument includes user login, operator IDs can be linked to each test. Printed reports and electronic exports should be protected from unauthorized editing. When data are transferred into reports or electronic systems, checks should be in place to ensure accuracy.

Finally, change control and training support the long-term robustness of the workflow. Any changes to the test method, equipment, or software should go through a formal change-control process, with risk assessments and, if necessary, revalidation. Operators must be trained not only on instrument operation but also on the underlying principles of the test and the importance of compliance. Training records should be available for auditors to review.

By combining these elements—documented methods, controlled equipment, robust data management, and structured change and training processes—labs can build an impact testing workflow that stands up to scrutiny. This not only satisfies regulatory expectations but also increases confidence in the results used for product development, release, and complaint investigation.