Work Instructions for ectd US-FDA ANDA Submissions
1. Logon to the PharmaReady ectd System Work instructions for US-FDA ANDA Submissions PharmaReady is a Web-based application. The logon screen and all PharmaReady pages are accessed via a Web Browser. 1.1. Launch a browser window and enter the appropriate URL. This opens a Logon Page and prompts you for your Logon ID and Password, as shown in the below figure 1: Figure 1 1.2. Login using appropriate credentials as shown in above Figure 1.
1.3. After login you will be placed in the PharmaReady Home page screen, which is shown in Figure 2 Figure 2: Central Page
2. Add Regulatory identifier(metadata s) Work instructions for US-FDA ANDA Submissions 2.1. Go to admin and select regulatory identifiers as shown in below Figure 3. Note: User should have ectd administrator rights to view regulatory identifiers option. Figure 3: Regulatory identifiers 2.2. In regulatory identifiers page, select product name from drop down and click on Add a new identifier button then add product name and click on submit as shown in Figure 4, 5 and 6.
Figure 4 Figure 5
Figure 6 2.3. Repeat the steps 2.2 for program and sponsor. Enter the following details as shown below Table-1 Table-1 S. No Identifier Type Name 1 Product name OQ TEST PRODUCT 2 Program Capsule 3 Sponsor Navitas
3. Create Application 3.1. To create an application, navigate to ectd module then select the ectd main menu and then click on Create Application as shown in Figure 6. Figure 6: Create Application
3.2. After clicking on create application user is placed in Application Properties screen as shown in Figure 7. Figure 7: creation of Application Properties 3.3. Enter the following under Key Identifiers for new Application field in application properties screen as shown in Figure 7:- a) Select Owner as admin from Available list b) Select Sponsor as Navitas c) Select Program as Capsule d) Select Regulatory Body as FDA. e) Select Product name as OQ TEST Product
f) Click on Specify Additional Products icon and select type as Established for ANDA Products and click Add (as shown in Figure 8). Product Type is added in additional products field and now click close. Figure 8: Select Type as established for ANDA submission g) Now, select Application Type as anda h) Enter Final Application No as 456456 Note: - In the Final application No. field enter Pre-assigned 6-digit number provided by US FDA. If the Pre-assigned application number is not provided enter temporary 6 digit number in Temp Application No field. Later when you receive Pre-assigned Application number you can delete Temp Application No and enter Pre-assigned Application in Final Application No field.
i) Under Action field, Click on Add New Sequence check box as shown in Figure 9 and click on submit. Figure 9: Click on Check box before Add New Sequence. j) In opened dialog box, click on OK to save the applications. The application will be saved and Add new Sequence Screen will get open. Refer Figure 11-A: Add new Sequence
Figure 10: Click on OK 4. Create Sequence 4.1 In Add new sequence screen enter the details as per below Table 2. S. No Heading Value 1 Submission Type Original application 2 Mode Click on radio button before Manage: Allow edits to the sequence. 3 Sequence Editor Admin (respective users can be assigned) 4 Publisher Admin (respective users can be assigned) 5 Approver Admin (respective users can be assigned) 6 Reader Admin (respective users can be assigned)
Figure 11-A: Add new Sequence
Figure 11-B: Add new Sequence 4.1 Let approval cycle be sequential 4.2 Key dates are optional field, if needed enter the dates 4.3 Click on submit button you will find a dialog box as Sequence Will be Saved click on OK. 4.4 Dialog box window will display as Changes saved. Continue to edit properties? Click Cancel See Figure 12.
Figure 12 5. Work with submissions Created applications will be listed in work with submission page. 5.1 Navigate to ectd module then select the ectd main menu and then click on Work with Submission as shown in Figure 13.A and 13.B. Figure 13.A: Go to work with submission
Figure 13.B: Go to work with submission 5.2 Filter your Applications based on 3 filter option i.e. Sponsor or Program or Regulatory body or Product. Select sponsor filter as Take Solutions LLP as shown in Figure 14. Figure 14: Working product name OQ TEST PRODUCT
5.3 Now click on expand button before OQ TEST PRODUCT under Product heading, and then click on manage icon below Manage column. See Figure 15. Manage sequence screen will be displayed. Figure 15: Working product name OQ TEST Product
6. Work with submissions In manage sequence screen click on expand icon before the OQ TEST Product/FDA 456456 folder and select sequence.right click on 0000 sequence and select add module or select Add Module from Node action drop down under the section Properties and click GO. See Figure 16. Figure 16: Add module from section properties
7. Add Module 7.1 In Add module screen see Figure 17, click on choose template. You will be placed in template manager screen. Figure 17: Add module screen 7.2 Now in template manager screen see Figure 18.select the radio button before FDA regional standard template and click on apply selected template button. 7.3 Repeat 7.1 to 7.2 for module 2 to 5 and select standard templates. 7.4 After selecting M1 to M5 templates, below select text check all boxes from Add Module screen. See Figure 19 and click on save button.
Figure 18 8. Add Documents in Module 1 Figure - 19 As per the submission map (ANDA) documents are uploaded in various modules inside the PR Application.
8.1 From Manage Sequence page click on before FDA Regional, then click on Admin button, then click on Properties button from the middle of the screen or right click on admin section and select Properties, see Figure - 20. Figure - 20
8.2 Then user will be placed in admin screen as shown in Figure 21, Update the submission date if required and check the other data s. Then click on Submit. Figure 21 8.3 Now click before M1 Regional, you will find US-M1 Regional Module sections and subsections.
8.4 Click on any section, here for e.g. click on M1.2 Cover Letters section and select Add New Doc option under Node Action drop down, then click on Go button see Figure 22. Figure 22 8.5 Now you will be in Add Documents screen as shown in Figure 23. You have 4 different methods of adding documents: a) Add from DMS is a method of adding a document from PharmaReady DMS into PharmaReady ectd system.(note: you should have DMS license to use this option) b) Add from Sequence is a method of adding a single document multiple times which is already uploaded in a particular section in a module. c) Add from share is a method of adding a document in PharmaReady ectd system from an organization s network share directory or folder.
d) Add from Local is a method of adding a document from the local PC. Figure 23
8.5.1 Click on Add from Local button which opens the Add Doc from Local Page as shown in the Figure 24, On the Add Doc from Local page, you can browse the document from your local PC and upload. Figure 24 8.5.2 Click on Add from Share button which opens the Add Doc from Share Page as shown in the Figure 25, On the Add Doc from Share page, enter the network path where your files are located. Figure 25
8.5.3 Enter the Starting Directory and click the Show Files button, which displays the available files in the specified location as shown in Figure 26. Figure 26 8.5.4 Once you have selected your documents to add to a section, you have a few additional actions to perform on the Add Documents Page Figure 26 as listed below: a) Change Title (Optional) b) Retain Original Format (Optional) c) Submit (Mandatory)
Figure 26 8.5.4.1 Change Title - To change the title of the document section, click the Change Title button, which allows you to edit the Title field as shown in the Figure 27. Before submitting the document, click on Update button to save the changes you have made to the title of the document.
Figure 27 8.5.4.2. Retain Original Format- By this option you can allow the system to automatically convert the file into a PDF, which is the default, or retain the document s original format. To retain the Original Format of the document, click Retain Original Format check box against the required document. When you have made your selections, mark the Select checkbox for each document and click the Submit button. You are returned to the Manage Sequence Page (as shown in the figure below Figure 28), where you can continue building the ectd.
Figure 28 9. Additional tasks with uploaded leafs from Manage Sequence 9.1 As you build the ectd, you may find that you need to perform additional tasks with leafs and these can be performed in the Manage Sequence Page: a) View and Edit Leaf Properties b) Re-order Leafs c) Remove Leafs 9.1.1 View and Edit Leaf Properties: - Every document, or leaf, has a unique set of properties that reflect information to appear in the XML file. a) In the Manage Sequence Page, Select the desired folder from the directory to display the documents. b) Select a document that you wish to view the properties and right click the document there you find an option to view the document or in the right hand side you can find a drop down option
under the node action section there also you can find the View Document option to View the document. This displays the properties of the selected Leaf as shown in the Figure 29. Figure 29- Manage Sequence page (leaf properties) c) Edit the fields in the Leaf Properties Section, as desired. d) Click the Update button to save the changes. 9.1.2 Select Re-order Leafs - You can change the position of the Leafs in the Manage Sequence Page. To reorder documents within a section, Select a section, then right click and select leaf reorder option as shown in the below Figure 30.A, 30.B, 30.C.
Figure 30.A Figure 30.B
Figure 30.C 9.1.3 Remove Leaf (s) a) To remove documents, click the document that you wish to remove in the Leaf Documents Section. b) Right click the document there you can find an option to Delete Leaf or in the right hand side you can find a drop down option under the node action section there also you can find the Delete Leaf option to delete the document, as shown in Figure 31. c) Click the Confirm Remove button to Remove the selected Leaf, or click the Cancel Remove button to withdraw the Removal process.
Figure 31 Remove Leaf
10. Add Documents in Module 2 10.1 The documents are uploaded in module 2 based on submission map prepared. 10.2 Upload the documents in module 2 by the following steps 8.4 to 8.5 Note:- In module 2 you have to provide attributes in M2.3.S Drug substance and M2.3.P Drug product. These attributes has to create under ectd master data. To create attributes go to admin ectd master data under ectd module. Note: You should have ectd administrator rights to create attributes under ectd master data. In regulatory identifiers page, select product name from drop down and click on Add a new identifier button, then add product name and folder name, then click on submit as shown in below figure 10.2 A and B. Follow the same procedure for other attributes like substance name, Manufacture name, excipient name, Dosage form and Indication. Note: For all attributes, ensure the folder names are kept less than 10 characters. Figure 10.2 A
Figure 10.2 B 10.3 Click on before M2 summaries, M2.3 Quality Overall Summary M2.3.S Drug substance, then select substance or API information as wonder pill API, manufacturer as wonder pill API Manufacturer then click on Update button. See Figure 32.
Figure 32 10.4 Click on before M2 summaries, M2.3 Quality Overall Summary M2.3 S Drug Product, then select product name as Wonder pill Dosage form as Tablets and Manufacturer as wonder pill manufacturer then click on Update button. See Figure 33.
Figure 33. 11. Add Documents in Module 3 11.1 The documents are uploaded in module 3 based on submission map prepared. 11.2 Upload the documents in module 3 by following the steps 8.4 to 8.5 Note 1:- In module 3 you have to provide attributes in M3.2.S Drug substance and M3.2.P Drug product. Follow the steps 10.2 to 10.4 to provide attributes for M3.2.S Drug substance and M3.2 P Drug Product. 11.3 Control of Excipients Creation of Excipient 1
11.3.1 Click on before M3 Quality, M3.2 Body of Data M3.2.P Drug Product M3.2.P.4 Control of Excipients, enter excipient name as excipient 1 and click on update button, see Figure 34. 11.3.2 Upload specification document in M3.2.P.4.1 Specifications by following steps 8.4 to 8.5. Figure 34. Creating Excipient 1
11.4 Control of Excipients - Create excipient 2 Work instructions for US-FDA ANDA Submissions 11.4.1 Click on M3.2.P Drug Product click on drop down below Section Properties and Add section click on GO button see Figure 35. Figure 35- Adding new section for excipient 2
11.4.2 Now you will be in add section screen see Figure 36 select M3.2.P.4 Control of excipients and click on Add section button. Figure 36 - Adding M3.2.P.4 Control of excipient section for Excipient 2
11.4.3 You will find new M3.2.P.4 Control of excipients is created for excipient 2, after clicking on M3.2.P.4 Control of excipient, enter excipient name as Excipient 2 and click on update Figure 37. Figure 37
11.5 Add Document Module 3 - M3.2.A Appendices Work instructions for US-FDA ANDA Submissions 11.5.1 From the M3 Folders Section expand M3.2.A Appendices in Figure 38 Figure 38
11.5.2 Expand M3.2.A Appendices and select M3.2.A.1 Facilities and Equipment and provide the attributes as shown below table Table 3 and Click Update button Table 3 S.NO Heading Attribute 1 Substance Wonderpill 2 Product Name WonderDrug 3 Dosage Form Tablet 4 Manufacturer Test Manufacturer
12. Creation of Study Tagging Files (STF) in Module 4 and 5 Expand the folders (in the ectd Folders section) to access the section, in which you want to add the STF leaf as shown below figure 39: Figure 39 12.1 In the Leaf Documents Section, select Add New STF from the drop-down list as shown in above figure 39:-
12.2 Click the Go button. This displays the Create New Study Tagging File Page as shown in the Figure 40 12.2.1 Below study identifier heading enter Study Title - Fast Study STF Study ID - FS-101 and click on Save Study Identifier button. Figure 40
12.3 Below study documents heading Click on drop down list select Add new doc click on go button and add STF documents. See below figure 41. Figure 41
12.4 Metadata to STF files 12.4.1 In the Study Tagging File Manager page. You now add metadata for each child leaf as you did when creating a new STF. 12.4.2 For every document in STF select appropriate Info type and name associated with Info type document, as shown in below Figure 42. In this way every document associated with STF should be provided appropriate Info type and name. Figure 42
13. Compilation of Dossier 13.1 For compilation click on compile button. Figure 43 Figure 43 13.2 After clicking compilation, there will be a status message: In Progress. Click on Refresh button after 3 mins to see the status. Figure 44
Figure 44
13.3 After Compilation click on the preview ectd icon located in the right side of manage sequence screen as shown below Figure 45. Figure 45
13.4 After clicking on the preview ectd icon you will find web browser view as shown below figure Figure 46 Figure 46
14. Validation of Dossier 14.1 After Compilation is successfully click Validate icon located in the right side of manage sequence screen as shown below Figure 47 Figure 47
14.2 After Validation the system will display Validation Status as shown below Figure 48 Figure 48
15. Approve Dossier 15.1 To approve the submission click on Sequence Properties in the manage page - Figure 49 Figure 49
15.2 From the Maintain sequence properties screen, click on radio button before approve to change the mode from manage to approve and click on submit button. As shown in below figure Figure 50 Figure 50
15.3 From the work with Submissions click on icon and approve the submissions from Approve screen as shown in Figure 51 and 52. Figure 51 Figure 52
16. Publish 16.1 To publish the submission click on Sequence Properties in the manage page - Figure 53. Figure 53
16.2 From the Sequence Properties screen, click on radio button before publish to change the mode from approve to publish and click on submit button. As shown in - Figure 54 Figure 54
16.3 From the work with Submissions click on icon and publish the submissions from publish screen as shown in Figure 55 and 56. Figure 55 Figure 56
16.4 After publish the submissions, go to ectd compile location you will find zipped folder for the published submission please find figure 57. Figure 57 17. Deliverables 17.1 The zipped folder is deliverables from the PharmaReady application located at ectd compile location. Copy the zipped file in secure location unzip the file, you will find folder copy the folder in appropriate transmission media and label properly in CD or DVD and send to agency. If ESG gateway is setup then transmit the folder through ESG.