Starting off a new year can be daunting. The best way to alleviate the anxiety is to prepare for the coming year. Below are 15 things that you can do to prepare yourself and your company for the coming year.
1. Review open investigation (deviations, exceptions, out of specification, customer complaints, etc.) reports from the last year. Determine the items needed to close the reports.
2. Review open Change Controls from the last year. Determine the items needed to close the reports.
3. Review open CAPA reports from the last year. Determine the items needed to close the reports.
4. Review open audits from the last year. Determine what still needs to be completed.
5. Review the last FDA inspection your company had. Have all the 483 observations been completed as per the response submitted to the FDA?
6. Review the equipment cleaning validation program. Do you need to take annual swabs to verify the effectiveness of the cleaning validation? Have those been completed for the last year? Did you set a schedule for the coming year?
7. Review the stability program. Have you placed at least one lot of each active product on stability to confirm the retest/expiration period for the last year? Have you set a schedule for which products and lots you will need for this year?
8. Review the USP Reference Standards in the laboratory. Have any of the standards expired and need to be replaced?
9. Review all the Federal, State and Local registrations for your company. Have they all been renewed for the coming year? Is there a schedule in place to ensure the upcoming ones are not missed?
10. Review all of the SOPs and determine which documents are due for review for the coming year. Is there a schedule in place to review and update them?
11. Gather all of the data needed to complete your annual product reviews. Ensure all the batch records for the previous year have been reviewed, all the testing reports have been completed and the retain samples have been inspected for the products and lots produced for your review period.
12. Create or make sure the internal audit schedule has been created for the coming year.
13. Create or make sure the calibration and maintenance schedule for the plant and laboratory equipment is prepared for the coming year. Make sure any new equipment has been added to the schedule.
14. Create or make sure the employee training schedule to ensure annual GMP training is completed has been created for all employees. Make sure any new employees have been added to the schedule.
15. Create your management review meeting schedule as appropriate.
Have we missed any? Is there anything else that you do to help get ready for the new year? Leave a comment to let us know.
The Editors of GMP Trends