Follow
1. New development plan available
2. Job responsibilities for newly joined employees are available
3. Are the scale-up and commercial batch production stages and data reviewed to demonstrate adequacy of scale-up process?
4. Do the scale-up show consistency among batches?
5. Are the in-process and finished product specifications established on the basis of pilot batches?
6. Are the development reports reviewed to determine the capacity of producing the product adequately?
7. Do these development reports serve as the basis for validation of manufacturing and control process?
8. Is there a formal stability review programme? Check the stability data of few batches under development, batches released for production in last quarter?
9. Are issues of MFR controlled -Check both current and superseded versions?
10. Are process validation studies carried out ? Check process validation report of any product done along with BPR for comparison?
11. Check compliance status of previous audit finding
