Eagle Analytical Process Validation Testing

Transcription

1 Eagle Analytical Process Validation Testing Overview: Quality Control begins by identifying processes in the pharmacy and defining the standard operating procedures, (SOPs) that make up these processes. Once these processes are defined and implemented they are validated through testing to insure that the products intended quality has been achieved. These processes remain validated through random testing in order to insure that they still meet the established standards. The Eagle Analytical Process Validation Testing utility allows you to define these processes and SOPs, as well as aiding in lot testing based on pharmacy set testing guidelines. Setup: The pharmacy needs to have an account login with Eagle Analytical. If you don t have an account with Eagle Analytical you will need to register your Pharmacy with them in order to obtain a username and password. Once you have an account with Eagle Analytical; in The Compounder select QA/QC > Eagle Analytical Services Process validation application. This will open the Process Validation Testing utility. Select Login Settings, and enter the Username and Password for your Eagle Analytical account You will also need to supply an for notifications in The Compounder under File > Options > tab 2. Numbers in the field. Help Documentation is available under the Help menu option within the Eagle interface. To visit the Eagle Analytical website go to or click the link. Last Revised: March 3, 2014 Page - 1 -

2 The Pharmacy now needs to establish the processes that are used in the Pharmacy. By default, the utility comes with a basic set of processes. You can add new process by selecting Processes and then the, you can delete processes you created by selecting the, however default processes can t be deleted. You can also set the minimum, standard or high testing recommendations, by selecting the appropriate setting in the menu bar. This will establish the percent of logs to be tested. The Pharmacy now needs to establish the standard operating procedures, (SOPs), which are used in a process. By default, the utility comes with a basic set of SOPs. You can add new SOPs by selecting SOPs and then delete SOPs you created by selecting the, however default SOPs can t be deleted., you can Last Revised: March 3, 2014 Page - 2 -

3 The Pharmacy then needs to link SOPs to Processes, they do this by selecting Link. Under Process description, select a process that you want to define. Under SOP description, select the SOPs that make up that process by clicking the the, beside that SOP. You can remove any linked SOPs under the Linked SOP description by selecting, beside that SOP. You can also reorder the SOPs using the Move up/move down buttons. The Pharmacy then needs to link the process to the dosage form by selecting Process and Formulas. In the drop down box titled Select process, select the process that you want to work with. In the drop down box titled Select dosage form, select the form that you would like to link the process to. You can use the Overwrite existing process checkbox to relink formulas to the new process. If it is not checked and a formula already as an associated process, that process will not be updated. To link the formulas to the selected process press the [Link] button. Last Revised: March 3, 2014 Page - 3 -

4 Basic Operations: Once the formulas are linked they will be available under the specified process, click on the [+] beside the process name to expand the formula names, click on the [ ] to collapse the formula names. In The Compounder on tab A. Technical of a Formula, you can use the Process drop down box to update or change the process for that Formula. Last Revised: March 3, 2014 Page - 4 -

5 Clicking on Logs To Be Tested, will allow you to set a Date Filter to Search for logs that are available for testing. The Select random logs on search checkbox will cause the software to randomly select the lots to be tested. The menu bar will allow you to control your selection and submission to Eagle Analytical. - Will clear out any logs that have been selected. - Will randomly select lots for testing based on your testing goals. The View Current Selections button will take you to the screen which will show the logs that have been selected. This menu bar will allow you to control your selections. Selected Logs: Is the number of logs that have selected for testing. - Will take you back to the initial Logs To Be Tested screen. - Will take you to the submission screen to fill out testing information. - Will mark your log as being sent and allow you to do a manual submission to Eagle Analytical. - Will provide you with a print out of logs that appear in the grid. Last Revised: March 3, 2014 Page - 5 -

6 When using the Prepare/Validate for Eagle button, you will be prompted for additional information. Contact Information Compounded by: This will default to the Technician listed on the log. P.O. # (if issued): If the Pharmacy issues a P.O. for this testing you can enter it here. Sample Information Sample Name: This will be the name, strength and form of the log submitted. Lot Number: This will be the lot# of the log submitted. Quantity: This will be the quantity that is being submitted for testing and it will be subtracted from inventory. Form of Sample: This is the log form that is being submitted. Activities to be analyzed: You can add up to 5 activities to be analyzed. Batch Number: This is a number internal to the pharmacy to help identify what product sample was submitted. Concentration per Active: This is the strength from the log that is being submitted. Storage: These are check boxes to indicate how the item should be stored. Room Temperature Frozen Refrigeration Light Sensitive Rush Available for Potency, Endotoxin and BUD Day 0 only at additional cost: This is a check box to order rush processing of your sample. Send Preliminary Results via: This check box indicates how you would like to receive the testing results. Fax: Web: Last Revised: March 3, 2014 Page - 6 -

7 Tests To Perform: These are check boxes to identify the testing that Eagle Analytical is to perform. Microbiology Rapid ScanRDI Microbial Detection Sterility, USP<71> (Bacterial + Fungal) Bacterial Endotoxin USP<85> Chemistry ph: Identification (ID): Potency: Beyond Use Dating (BUD): - Will prompt you to finish your submission to Eagle Analytical. You will need to print your packing slip and include it with your shipment. You will also receive a confirmation from Eagle Analytical. - If you have more than one sample to submit to Eagle Analytical, there will be a Next Sample and a Previous Sample button that will allow you move back and forth between the submissions. After you have submitted your log(s) to Eagle Analytical you will notice that your Goal % To Test and % Already Submitted will be updated to reflect the submission(s). Selecting Tested Logs Report will produce a Process Testing Status Report based on the date range selected. Last Revised: March 3, 2014 Page - 7 -

8 After the testing has been completed you will be able to click on Get Test Results. This will launch the Eagle Analytical website where you will be able to obtain the results of these tests. To store the testing results for the log, go to tab E. Docs & Images of the log that was tested and scan the printed copy of the test results. If you don t have a scanner you can save the file either locally or to a network share folder and assign a path to the document. Last Revised: March 3, 2014 Page - 8 -