GAMP- Good Automated Manufacturing Practice -Test Execution
After a test is written, reviewed, perhaps rewritten, and finally approved, it is then ready for execution.
Before commencing GAMP tests using individual Test Cases or Test Scripts, pre-requisites for the test phase should first be verified and recorded. For example:
- Test environment hardware (HW) (e.g., serial numbers and calibration certificates if required)
- Test software (SW) (e.g., SW baselines)
- Data sets
- User accounts
- Personnel involved (e.g., documentation of names, positions and sample signatures and initials)
- Availability of baselined documentation (including, most critically, Test Documentation and Procedures)
- Where applicable, calibration of critical instrument inputs
Manual Test Execution
Tests should be carried out as follows:
- Any pre-requisites for the test should first be checked, as indicated above.
- The test is then executed following the test instructions given within the Test Script.
- Each test should be run and the test data collected as test results.
- The tester decides whether the acceptance criteria have been met and records whether the test has passed or failed, and then signs and dates the test results. Sometimes, a third category ‘refer for review’, or ‘conditional pass’, or ‘pass with observation’ is used for cases where the tester feels that an independent opinion is required.
- Supporting documentary evidence required by the Test Case or Test Script should be collated.
- If an incident occurs, it should be recorded on a test incident sheet (or within the test incident system) and retained as part of the test record. The key to dealing with incidents during Test Script execution is to accurately record the incident and retain sufficient information to help with future problem solution.
- It is helpful to maintain a test progress summary for recording overall test results and number of test runs. Depending on the company test policy, this summary may be regarded purely as a status and scheduling tool, or may form part of the post-execution review, and may be included in the Validation Report as a GxP document.
- After completion of all tests or a group of tests (e.g., at the end of the day), there should be a review of the progress. A review group should assess all tests and incidents.
Possible actions for failed tests and incidents are:
- Repeat the test.
- Apply a change via change control and, if necessary, repeat the test.
- Abandon one, several, or all tests.
- Review the result, and upgrade it to a ‘pass’ status (with a record of the rationale for the change in status).
The review group should decide which course of action to take and what retesting is required, and document the justification for the action(s). In my next post I will elaborate more on: Automated Test Execution (and Computerized Test Management Tools).