A Lot Sample
LabWare LIMS Version 5 User Guide
4.19 Lot Manager
What is a Lot? | A Lot is a collection of samples that is associated with one or more stages of manufacture. Within some industries, the term Batch is also used. |
How do I get to Lot Manager? | To open Lot Manager, select the Open LotManager menu item from the File menu on the LIMS Main menu. |
What is Lot Manger used for? | Lot Manager is designed to facilitate the checking of a Lot against specifications. |
Where are the fields see in the Summary View defined? | Lot Manager has been designed to allow the use of Lot Templates, like Project and Batch Templates. The fields for the Lot view are defined in the Lot Template. The Lot Template determines which fields are found in the Lot view. Refer to the section on the Lot Templates Table for further detail. |
NOTE: A sample can only belong to one lot at a time. |
Can a sample in a lot belong to a batch or folder? | Yes, the same sample can belong to a lot, batch, project and several folders. For example, a sample belonging to a lot in Lot Manager can be received in a folder in Folder Manager. The sample will then be shown as received in Lot Manager. |
NOTE: If a sample is changed in Folder Manager while the lot that it belongs to is open in Lot Manager, the change will not be seen in Lot Manager until the project is refreshed. When the lot is first opened in Lot Manager, the LIMS takes a look at the information for that sample. If the sample, test or result information is changed outside of the Lot Manager, the lot does not know about the change until the lot is refreshed. When it is refreshed, it will go out and look at the sample information and return all the current information about the sample. The LIMS uses this approach so that it does not constantly have to communicate with the database. If the LIMS constantly checked the database, there would be long time delays when viewing the information. |
Describe a time you spent a lot of money on something. You should say: What you bought When you bought it Where you bought it And explain why you spent a lot of money to buy it. Well, let me tell you about a time I spent a lot of money. It was Christmas time, but also it was time to get a gift for myself.
What is a Lot Result? | In addition to being a collection of samples, a Lot also has other information associated with it, including summarized results across all the samples. Lot Results are created as a result of specifications associated with the lot. If there are no specifications with a Spec. Class of Lot Result or Any Result you will not see any Lot Results in the lower pane of the Lot Results view. Refer to the section on the Product Specifications Table for further detail. |
- From a lot of 10 items containing 3 defectives, a sample of 4 items is drawn at random. Let the random variable X denote the number of defective items in the sample. If the sample is drawn randomly, find (i) The probability distribution of X (ii) P(x ≤ 1) (iii) P(x.
- Determination of sample size from the table (8.2) For a lot size of 850 and allowable percent defective 3%. Table 8.2 gives a sample size of 150 and acceptance number, c as 5. This means from the lot containing 850 parts, at random pick up 150 parts, inspect them and find out the number of defective pieces.
- A lot Lyrics: I love you / Turn my headphone down a little bit, yeah / For so many reasons / Yeah, yeah, yeah, yeah, yeah, yeah (I do), yeah, yeah yeah yeah / Yeah, yeah, ah, ah, whoa, whoa.
To enter the Lot Manager, select Open Lot Manager from the File Menu. The Lot Manager window will be displayed. Once a lot is opened using the Open menu item from the File menu or using the Open Lot icon, the Summary view for the lot will be displayed.
The Summary view shows the field information on the lot. The fields can be grouped and displayed on tabs, depending on the configuration of the Lot Template. Refer to the section on the Lot Templates Table for further detail on grouping fields. Refer to the section on Lot View for more information on this view.
In addition to the Lot view, Lot Manager has two other views, the Samples View and the Lot Results View.
The Samples View shows the samples in the lot (refer to the section on the on Samples View for more information on this view).
The Lot Results View shows the lot results for the lot. These results are not sample related results but are calculated from the specifications (refer to the section on the on Lot Results View for more information on this view).
Closing Lots is performed using the menu item Close Lot on the File menu.
Restoring Lots is performed using the menu item Restore Lot on the File menu.
Dispositioning Lots is performed using the menu item Disposition on the Edit menu after selecting the sampling point in the Lot Results view.
NOTE: In all views, if there are external links associated with the lot, icons will appear in the status bar associated with these files . In the Samples view, if there are external links associated with the sample, test or result, icons will also appear in the status bar associated with these files. Double clicking on the icon will launch the external link file. |
Lot Manager functions can be selected from the File, Edit, View, Drill,Genealogy, Audit and Help menus. Each menu is discussed in the following sections. Many lot functions can be accessed through icons. The following icons are found on the default toolbar.
Icon | Function | Equivalent Menu Item | |
Exit Lot Manager | File menu…Exit | ||
Create a new lot using a template | File menu…New | ||
Open a lot | File menu…Open | ||
Save the lot | File menu…Save | ||
Drill Down | Drill menu…Down | ||
Refresh the lot | File menu…Refresh | ||
Add a comment to the lot | Edit menu…Comment | ||
Split lot | Edit menu…Split Lot | ||
Print the lot report | File menu…Print Report | ||
View the Lot view | View menu…Lot | ||
View the Samples view | View menu…Samples | ||
View the Lot results view | View menu…Lot Results | ||
View the Lot Genealogy | Genealogy menu…Browse | ||
Assign an audit reason | Audit menu…Assign Reason | ||
Open Help file | Help menu…Contents | ||
The File menu provides the user with the following functions.
New | Create a new Lot. Refer to the following section on New Lot for more detail on this function. |
Open | Open an existing Lot. Refer to the following section on Open Lot for more detail on this function. |
Close Lot | Close the Lot. Refer to the following section on Close Lot for more detail on this function. |
Restore Lot | Restore a closed Lot. Refer to the following section on Restore Lot for more detail on this function. |
Refresh Lot | Refresh the Lot. Refer to the following section on Refresh Lot for more detail on this function. |
Refresh Lot Results | Refresh the Lot Results. Refer to the following section on Refresh Lot Results for more detail on this function. |
Print Report | Print the Lot Report. Refer to the following section on Print Report for more detail on this function. |
Print Preview | Display a Preview of the Lot Report. Refer to the following section on Print Preview for more detail on this function. |
Save | Save a Lot. Refer to the following section on Save Lot for more detail on this function. |
Exit | Exit the Lot Manager |
The New function is used to create a new Lot. A LIMS Browser for Lot Templates will be displayed.
NOTE: If the user only has access to one template then that template will automatically be loaded and there will be no prompt for a template. |
Once the template has been selected, click on OK. Lot Manager will be displayed with the fields from the template.
NOTE: Mandatory fields are shown in blue. Display Only fields and Title fields have a gray background and the user will be unable to change the displayed values. Title fields are enclosed with chevrons (<<< >>>). Disabled fields do not have a different color background but the user will be unable to change the displayed values. A disabled field is indicated by a field label that is greyed out. A disabled field requires data to be entered in another field before it is enabled. For example, on the Lot Template supplied with the base database (name = DEFAULT), the Grade and Sampling Point fields will be disabled until a Product is selected. Once a valid Product is selected a list of Grades and Sampling Points for the current version of that Product will be available. |
The Product, Product Grade and Sampling Point fields are needed to check specifications. However, the Lot Template may be designed to default values to these fields automatically and the fields may not be displayed if configured as Not Displayed in the Lot Template. Refer to the section on the Lot Templates Table for more on configuring these fields.
If included on the template, the Version field is related to the desired version of the Product. However, if a product version is selected that is not the current version, care has to be taken that the product version on the lot samples matches the product version on the lot.
If included on the template, the Supplier field is linked to the Supplier table, and is used to control the Lots to Go counter associated with Full Test Frequency (also known as Skip Lot Testing). Refer to the section on the Supplier Table for more information.
If included on the template, the Customer field is linked to the Customer table. If the selected customer has a report format assigned, then that format will be used for printing lot reports. Refer to the following section on Print Report for more information regarding Lot reports.
NOTE: If the Sample Plan field is present on the Lot Template, then a Sample Plan may be selected when the lot is being created. Otherwise the Sample Plan associated with the Product, if any, will be used. Refer to the section on the Sample Plan Table for more on Sample Plans. |
Enter values for the displayed fields, noting that the Browse button and Pull Down lists are available for some fields. Click on Save to save the lot. When the Lot is saved, the Lot Number and Lot Name will appear in the Title Bar. The Lot Name will be in parenthesis.
NOTE: The Lot Name is determined by the Lot Id Configuration specified on the Lot Template. Different Lot Templates can use different Lot Id configurations. Refer to the sections on the Lot Id Configuration Table and the Lot Templates Table for more information. |
The Open function is used to open an existing Lot. When this command is selected, the Open Lot Dialog is displayed.
If the Lot Name or LotNumber is known, then it can be entered into the appropriate field. Alternatively, the browse button, , on the Lot Name field can be pressed to view a list of Lots ordered by Lot Name for selection or the Browse button can be used to view a list of lots by Lot Number.
If values are entered for any of the Qualifier fields displayed, Product, Grade, Open Lots Only and Created After, then only the lots matching the qualified criteria are listed when either the Browse button or Lot Name browse button are used.
NOTE: A Grade can only be entered after a Product is selected. |
Once a Lot has been selected, the Lot is displayed in Lot View, with the Lot Number and Lot Name in the Title Bar. For more information on the Lot Manager display, refer to the section on Lot View.
The Close Lot function is used to close a Lot. The Closed flag for the lot is set to True.
In order to return a Lot to an active state, the Restore function is used. Refer to the next section for more detail.
The Restore Lot function is used to restore lots that have been closed. The Closed flag for the lot is set back to False and lot is considered Open again. To restore a lot the Lot must be the lot that is currently open in Lot Manager.
TIP: To open a closed lot, set the Open Lots Only field in the Open Lot Dialog to False. |
The Refresh Lot function is used to refresh the information contained in the Lot by accessing the database for a full update. A Lot will automatically refresh itself each time it is opened. Manual refreshing is necessary when changes have been made to the samples in a Lot while the Lot Manager is open on that Lot. This function will only read the most current database entries. It does not recalculate any of the statuses.
The Refresh Lot Results function is used to refresh the values for the Lot Results by re-running the summary calculations.
Lot Results will automatically refresh themselves each time a Lot is opened. Manual refreshing is necessary when changes have been made to the results that are used as source values.
The Print Report function is used to generate a Lot Report or Certificate of Analysis. If any of the Product, Grade or Customer records have a report format defined, that format will be used in the generation of the report. The Customer format takes precedence over the Grade and the Product, and the Grade takes precedence over the Product. When the report runs the system will automatically send the current Lot Number to the Report for use in the selection criteria. The Access Routine should be set up with SAMPLE.LOT or LOT.LOT_NUMBER as the first argument (Refer to the sections on Configure Reports, the Access Routines Table and the Query Tags Table for more information on configuring reports in general).
NOTE: If the report is successfully run, then the Lot is treated as reported, and the Report Date is stored in the database. If the Print Report function is run again on this Lot, the Lot is treated as Reprinted, and the Reprint date is stored and the Reprint flag is set to True. The Report Date is not affected by reprints, and can be included on the reprints. Each time the Lot is Printed the Report Number field will be incremented allowing the system to track unique Reports for the Lot. |
The Print Preview function is used to generate a preview of the current Lot Report. The report is displayed in a LIMS Report Viewer window.
NOTE: This command has no effect on the Report Number, Reported or Reprinted status of the Lot, even if the Print button is pressed within the LIMS Report Viewer. |
The Save function is used to save the Lot. The Lot and its field and result values will be saved for future use.
4.19.4.10 Exit Lot Manager
The Exit function closes Lot Manager. If the Lot has been modified, and has not been previously saved, then a Save Changes prompt is displayed.
The Edit menu provides the user with the following functions.
Disposition | Disposition the grade. Refer to the following section on Disposition for more detail on this function. |
Comment | Enter comments for the Lot. Refer to the following section on Lot Comment for more detail on this function. |
Sources | Define Source Lots for the Lot. Refer to the following section on Source Lots for more detail on this function. |
Split Lot | Split the Lot. Refer to the following section on Split Lot for more detail on this function. |
Import Results | Import Results from another Lot. Refer to the following section on Import Results for more detail on this function. |
The Disposition function is used to set the disposition status at the grade level. To use, the user must be in the Lot Results view. Click on the grade to be dispositioned in the top pane. Select Disposition from the Edit menu and a select dialog will open displaying values from the LOT_DISP list. Select a disposition and click OK. The selected Disposition will be displayed in the Disposition column in the top pane of the Lot Results view. The values in the LOT_DISP list are configurable and can be changed, added or deleted.
NOTE: The Disposition status is not actually changed until the Save button is pressed. After the Save operation, the Dispositioned Lot event will trigger. |
The Disposition function is only enabled if the Lot Results view is selected and either the Primary or Secondary Disposition Required flags are set to True for the related Sampling Point and the current user has the appropriate Function Privilege. Refer to the Sampling Point Table for more information on configuring sampling points.
TIP: The DISPOSITION field can be associated with a User Added Table instead of the LOT_DISP list so that can use the GROUP_NAME security so that only certain people can assign certain Dispositions. |
NOTE: This menu item is NOT on the default menu. You need to open the Configure Menus and Toolbar dialog to add this item to your menu. To open this dialog, double click any in the blank space to the right of the Help menu. Refer to the section on Menus and Toolbar for more on modifying menus. |
The Lot Comment function is used to enter a comment for the Lot. When the function is selected, the Comment Dialog is displayed. If the Lot already had a comment, then that comment appears in the dialog.
CAUTION: If you have the Lot Comment field on your template the value in the template field will overwrite any comments entered in this Comment dialog. So if you want to use this menu item be sure to remove Lot Comment fields from your Lot templates. |
Lot Sources are lots that are used in the manufacture of subsequent lots. A lot can have any number of source lots, and a lot can be a source for many other lots. The quantity used from each source lot is recorded.
The Lot Sources function is used to define the Source Lots for the open Lot. When the function is selected, the Lot Sources Dialog is displayed.
The Add button is used to add Lots to the list of Source Lots. When the button is pressed, the Lot Prompter appears. When a Lot is selected, the Quantity Used of the Source Lot is prompted for, along with the currently available quantity. The available quantity is calculated each time the Quantity Used From prompter appears and the Source Lot Quantity field is not reduced by the amount used.
Enter the amount of material from the source lot and press OK to close the prompter. The selected Lot appears in the Source Lot list.
The Remove button is used to remove a Source Lot from the list. When a source lot is selected, and the button is pressed, the Source Lot is removed from the list.
NOTE: The Remove command does not remove the source lot itself, only its use as a source lot for this lot. |
The Modify button is used to change the Quantity value for a Source Lot. When a Source Lot is selected and the button pressed, the Quantity Used prompter is displayed, with the previously entered value as the default. Change the value and press OK to close the dialog.
Press the OK button to close the Lot Sources dialog.
Split Lots are lots that are created when a lot is split into one or more lots, usually for the purpose of segregating portions of a Lot into good or bad material when only certain parts of the Lot are out of Specification. The Split Lots can be reclassified to different Grades and maintain a trail back to the Original or Parent Lot. If a lot is split, then the changes to one lot do not affect the changes to the original lot.
The Split Lot function is used to create a Split Lot from the open Lot. When the function is selected, a new Lot is created, with the same fields settings as the open Lot. The name for this lot is created by adding “-1” to the name of the Original or Parent Lot and a new Lot Number is assigned. Lot Results are copied to the new Lot and are indicated by a ‘-C’ (copied) in the Source Lot column. Every time the Original Lot is split, this value will increment. The newly created Split Lot is then automatically opened within the Lot Manager screen. No data from the Original or Parent Lot is associated with the new Split Lot. The Split Lot will have to be resampled. The Parent or Original Lot Results can be imported using the Import Results function. Refer to the following section on Import Results for further detail.
The Import Results function allows results to be imported from other Lots. When the function is selected, the Lot Prompter appears. When the Lot is selected, the Select Results To Copy dialog is displayed. If Lot Results exist for multiple Sampling Points within the selected Lot a Select Source Sampling Point dialog will appear. If no Lot Results are available for the selected Lot the user will be informed that no Results are available.
After selecting the Sampling Point if required, and the OK button is pressed, the Select Lot Results dialog will appear with the valid results for that Sampling Point.
Select the Results that are to be Imported and press OK. The Results will be copied into the current Lot. If the Lot Results in the Source Lot are changed the change will be reflected wherever the Lot Results were copied. Imported results are indicated by a ‘-c’ in the Source Lot column in the Lot Results view.
The View menu provides the user with the following displays.
Lot | View Lot Summary information. Refer to the following section on Lot View for more detail on this function. |
Samples | View Lot Sample details. Refer to the following section on Samples View for more detail on this function. |
Lot Results | View Lot Results. Refer to the following section on Lot Results View for more detail on this function. |
The Lot view is the default view and will be displayed each time a Lot is opened.
The Lot View displays summarized information for the Lot. The fields displayed are determined by the Lot Template. Notice, Lot Manager displays the fields on tabs. Each tab can have different fields that can be seen when the tab is selected. Refer to the section on the Lot Templates Table for more detail on configuring fields and grouping fields onto tabs.
The Samples View displays detailed information for the samples within the Lot.
This screen displays all the samples that match the selected Lot, Product, Sampling Point and Grade. The screen is divided between the left side, with the sample text IDs, and the right side, which displays the tests and results for the selected sample.
NOTE: If a test or result has a Reported Name, the name will appear in square brackets after the test or result name in the tree views, as shown in the previous figure, where the LOD test and pH have reported names. |
When a sample on the left is selected, the right of the screen refreshes to display the tests and results that are required by the Product Specification for that sample. This display also displays the Specification for the results, and whether the result value passes the Specification (indicated with a checkmark) or fails the Specification (indicated with a X). A yellow ‘?’ will appear if a result has not been entered. The sample is checked against any specification with a Spec Class = Result or Any Result. Specifications with Spec Class = Lot Result, Batch Result or Project Result are not checked at the sample level.
If the sample is double-clicked, or the Drill-down button on the toolbar pressed, the Sample Drill Down window appears.
The tree view in the left pane can be expanded to show tests and results by double clicking on the sample or test or by clicking on the + sign. Refer to the section on Sample List Display for more information on the information displayed in the right pane.
Click on the History button to view the sample audit history. Refer to the Sample Audit History section for more information on this dialog.
Click on the Close button to exit the Sample Drill Down dialog.
The Lot Results View displays the results that apply to the entire lot. The top pane of the screen shows the specification summary. The lower pane shows the lot results.
The top pane of the screen shows a Grade record for the Primary Grade and any Grade that is marked as ‘Always Check’ in the Product Specification. The blue star in the top pane indicates the Primary Grade for the lot.
A Lot To Lose 24kgoldn Sample
Checkmarks, indicating everything is OK, or Xs, something is wrong, are displayed for each of the following criteria:
· The Tests Done summary indicates that all required testing for the samples in the Lot has been performed. If so, a checkmark is displayed; if not, an X is displayed. A sample is added to a lot for the first time and no results have been entered yet, the Test Done column will have an X. All remaining columns will have green checks.
Are Right A Lot Sample Answers
· The Primary In Spec (P.I.S.), indicates all the Sample Results and Lot Results for the Lot are within Product Specifications for the selected Grade. If all results are within the Specifications, then a checkmark is displayed; if not, an X is displayed.
· The No Rejects summary indicates if any Lot samples, tests or results have been rejected. If the samples have no rejections, then a checkmark is displayed; if not, an X is displayed.
· The No Modifications (No Mods.) summary indicates if any result has been modified. If no modifications have been performed, a checkmark is displayed; if any result has been modified, an X is displayed.
· The All Reviewed summary indicates whether all the samples for the Lot have been reviewed. If they have, then a checkmark is displayed; if not, then an X is displayed. Note that reviewed includes both Authorized and Rejected samples, tests and results.
The bottom part of the screen shows Lot Results at the selected Sampling Point and Grade. A Grade record is displayed for the Primary Grade and any Grade that is marked as ‘Always Check’ in the Product Specification.
NOTE: Lot Results will only be displayed if there are specifications that have a Spec Class = Any Result OR = Lot Result. |
The Valuedisplayed is the average of all the same results for the Lot samples that match the Lot’s Sampling Point and Grade.
The Specification is also displayed, along with an indication of whether the value has passed (green checkmark) or failed (red X). The Lot Result Value is checked against any specification with a Spec Class = Any Result or Lot Result.
The Source column indicates the Lot or Lots that provided source values for this average. If a Lot Result is imported from another Lot an entry will be created for that Lot Result and will NOT be updated if new samples are added for the current Lot at the same Sampling Point and Grade.
The Lot Results are not computed or refreshed until the Refresh Lot Results function is called from the Lot Manager File menu, or the Lot is reopened from Lot Manager. The Lot Rslt All Grds field on the Lot Template determines whether the lot result values for secondary grades are stored in the database. If set to False, only the lot results for the primary grade are stored in the database. If True, all lot results are stored in the database.
NOTE: The specification Status of the Lot is a combination of the Sample Statuses and the Lot Results Statuses. The Lot Results are calculated from the average of the sample results. Only a specification that has a Spec Class = Any Result or = Lot Result will be evaluated and displayed in the Lot Result View and determine the In-spec status of the Lot Result. The Sample In-spec status is determined by comparison with any specification that has a Spec Class = Result or = Any Result. | ||||
Sample Status | Lot Result Status | Resulting Lot Status | ||
All In spec | All In spec | In spec | ||
One or More Out of Spec | All In spec | Out of Spec | ||
All In spec | One or More Out of Spec | Out of Spec | ||
NOTE: A Lot Result for a secondary grade will not be calculated unless the primary grade has a lot result defined for the same component or if the Lot Rslt All Grds field on the Lot Template is set to True. |
The Genealogy menu provides the user with the following functions.
Browse | Browse the Lot Genealogy |
4.19.7.1 Browse
To view the lot genealogy, select Browse from the Genealogy menu. The Lot Genealogy Browser dialog will be displayed.
Initially the Open Lot button is disabled. Once the user clicks on a lot in the tree view then the Open Lot button is enabled, as shown in the following figure.
If the user clicks on the Open Lot button once it is enabled, a new Lot Manager window will open displaying the selected lot.
Click on the Exit icon to close this Lot Manager window.
Click on the Close icon, , in the upper right corner of the Lot Genealogy Browser dialog to close the dialog.
The Drill menu is used to open the Sample Drill Down display. Click on a Sample in the Samples view then select Down from the Drill menu.
The tree view in the left pane can be expanded to show tests and results by double clicking on the sample or test or by clicking on the + sign. Refer to the section on Sample List Display for more information on the information displayed in the right pane.
Click on the History button to view the sample audit history. Refer to the Sample Audit History section for more information on this dialog.
Click on the Close button to exit the Sample Drill Down dialog.
The Audit menu provides the user with the following functions.
Audit Reason | Assign an Audit Reason |
Audit History | View the Audit History |
The Audit menu items are functional only if the Audit all changes business rule is enabled.
4.19.9.1 Audit Reason
To record an audit event, select AuditReason from the Audit menu. The Audit Dialog will be displayed. Enter the audit reason and click on OK.
NOTE: When the audit dialog is opened, you may see an audit reason defaulted in the dialog. The last entered audit reason since login is always displayed in an audit dialog. When you change the audit reason this will become the new default audit reason for the audit dialogs. This default audit reason will be cleared when a new audit reason is entered in an audit dialog or when the user logs out of the LIMS. |
4.19.9.2 Audit History
To view the audit history, select Audit History from the Audit menu.
NOTE: The audit Timestamp field is always displayed in Greenwich Mean Time (GMT). This is to allow for uniformity in the audit timestamp for multi-site implementations that may cross different time zones. As a result you may see a difference in the audit timestamp and the CHANGED_ON field times in some audit dialogs.. |
The Help menu will open a help file on Lot Manager.
LabWare LIMS Version 5 User Guide Copyright ©LabWare, Inc. 1994-2003 - All Rights Reserved |
Lot Release
What is lot release?
Lot release is a mechanism that provides FDA with a real-time system to continuously monitor product quality, through review and testing, of many of the biological products that it regulates.
Biological products licensed under the Public Health Service Act are subject to the lot release requirements of Subpart A of 21 C.F.R. Part 610 (General Biological Products Standards):
- 21 C.F.R. §610.1 provides that “[n]o lot of any licensed product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product . . . “
- 21 C.F.R. §610.2(a) and (b) provide that “[s]amples of any lot of any licensed product together with the protocols showing results of applicable tests, may at any time be required to be sent to the Director [of the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research, as appropriate] . . . Upon notification by the Director . . . a manufacturer shall not distribute a lot of a . . . product until the lot is released by the Director . . .
What happens before the biological product is licensed?
As part of the approval of many biologics license applications (BLAs), the responsible Center (the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER)) works with the applicant to develop a lot release protocol that will be used for each lot of product post-licensure. The Center also develops a test plan for independent confirmatory testing by the Agency.
What happens after the biological product is licensed?
Once the Agency has licensed such a biological product, for each product lot, the applicant must submit materials relating to that lot to the Agency before the lot can be released.
- What lot release materials must the applicant submit to the Agency?
- Protocols: The applicant must submit the protocols that contain the agreed-upon tests.
- Results: The applicant must submit the results of the testing performed by the applicant.
- Samples: The applicant generally must submit samples of the product from the lot in question in order to permit the Agency to perform confirmatory testing.
- How should the applicant submit the lot release materials to the Agency?
- Electronically: The Agency encourages applicants to submit lot release protocols and results to the Agency electronically through the Gateway, which facilitates the lot release process.(Currently, over 55% of lot release protocols are submitted electronically.)Interested applicants should first contact the Sample Custodian at the address below.
- Samples: should be submitted by courier to the Agency’s Sample Custodian. An applicant seeking to submit protocols and results by mail or courier should direct these to the Agency’s Sample Custodian, as well. Note that applicants should send protocols, results, and samples for CDER-regulated products, as well as for CBER-regulated ones, to the Sample Custodian at the following address:
Sample Custodian
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO75-G707
Silver Spring, MD 20993-0002
- What happens after the applicant has submitted the lot release materials to the Agency?
Once the Agency has reviewed the lot release protocol, completed any testing of samples, and has found the results acceptable, the Agency will notify the applicant that that lot has been released. - How long will it take for a product lot to be released by the Agency?
Please note that there is no required timeframe for lot release. However, the Agency strives to release lots within 30 business days once a complete and accurate submission has been received. This is the length of time that the Agency generally expects to need in order to review the data and multiple test results contained in a protocol and conduct confirmatory testing. If it becomes necessary for the Agency to resolve an issue with a protocol, or request the submission of a corrected protocol, the lot release process may take longer.- In situations of true product shortages, an expedited release may be requested. A request should be made to CBER’s Product Shortage Coordinator at cbershortage@fda.hhs.gov.
Is there other information that applicants should know about the lot release process?
Yes. Please note that lots that are submitted in support of an application or a prior approval supplement (PAS) cannot be released until the application or supplement is approved.
Follow CBER
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
For Updates on Twitter, follow @fdacber