List of Non Routine Validations Activities Performed by Quality Assurance (QA)

Describes List of Non Routine Validation activities for OSD Formulations.

What is mean by Non routine Validations ?

The validations which are performed other than Routine process validations termed as Non routine validations. It is important to perform non-routine validation to identify and address any potential issues before they become problems that impact product quality, safety, or efficacy. It is essential to have a well-defined validation plan, identify and address potential risks, involve all stakeholders in the process, and document all activities and results.  Some of the non routine Validations like hold time can be clubbed with the Routine validation activities. It will depend on case to case scenario.

List of Non Routine Validation Activities :

1. Disinfectant hold time study
2. Dirty/To be clean area hold time study
3. Clean area hold time study
4. Dirty/To be clean equipment hold time study
5. Clean equipment Hold time study
6. Blend Hold Time study
7. Lubricated Blend Hold Time study
8. Sifted powder mix Hold Time study
9. Compressed Tablets Hold Time study
10. Coated Tablets Hold Time study
11. Binder Hold Time study (For starch separate Hold time study will be done)
12. Study of failure of Corridor AHU
13. Hold time study for Coating suspension
14. Inlet process air monitoring by air Sampling
15. Tablets tilting on Inspection Belt
16. Tablet/Capsule inspector validation
17. Validation of effectiveness of of Disinfectant solution
18. Rate of cooling of binder Temperature
19. Drain Time of purified Water
20. Drain Time of Potable Water
21. Dummy Recall Validation
22. Hold Time study of FBE Finger Bag
23. Hold time study of purified water in storage tank
24. Study of Exhaust air quality of AHU, Dust Collector
25. Study on Effective filter Cleaning of cleanable filter (HVAC)
26. Justification of lead time prior to Laminar Air Flow Operation
27. Justification of lead time prior to AHU operation for Temperature and RH conditions
28. Metal detection of Chips at different speed of compression machine
29. Computer System Validation (CSV)
30. Method Transfer Validation
31. Revalidation due to Changes in Raw Materials
32. Container Closure Integrity Testing validation
33. Validation of Special Processes (e.g., aseptic processing, lyophilization)
34. Primary Packaging Material Validation
35. Transport Validation