Adding More Storage Conditions to a Stability Study

Use

You normally specify storage conditions for a stability study before you begin the stability testing phase. If you decide to add one or more storage conditions after you have already specified storage conditions in the study for the first time, you must proceed in different ways, depending on what activities have already been performed in the stability study.

Procedure

To specify additional storage conditions in a stability study, perform the appropriate procedure outlined in the table below, depending on the current processing status of the study.

If the following activities have been performed in the stability study:	Then proceed as follows:
Storage conditions have been specified A testing schedule has not been created	Specify the new storage conditions using the follow-up function Specify Additional Storage Conditions . No additional activities are necessary.
Storage conditions have been specified A testing schedule has been created A start date for the stability study has not been specified (that is, scheduling has not been triggered for the testing schedule)	Choose one of the following options: Create a new item for the storage condition in the testing schedule manually using the follow-up function Change Testing Schedule . Create a new testing schedule using the follow-up function Create Testing Schedule . A new testing schedule will be created that contains all previously existing storage conditions, as well as the new storage condition. The original testing schedule will be deleted. Note If you choose to create a new testing schedule, note the following points: End of the note. The new testing schedule will have a new key that will not necessarily be the same as the key for the stability study. You must reassign the inspection plans to all storage conditions (items) in the testing schedule.
Storage conditions have been specified A testing schedule has been created A start date for the stability study has been specified (that is, scheduling has been triggered for the testing schedule) Dates on which the new storage condition is to be tested exist in the testing schedule None of these dates have been called	Manually create a new item in the testing schedule for the new storage condition. In the transaction for scheduling the maintenance plan (testing schedule), restart the scheduling process and delete the old test dates in the process (as prompted in a dialog box). Note When you restart the scheduling process, the system uses the original start date you defined for the stability study to recalculate the test dates. End of the note.
Storage conditions have been specified A testing schedule has been created A start date for the stability study has been specified (that is, scheduling has been triggered for the testing schedule) Dates on which the new storage condition is to be tested exist in the testing schedule The dates on which the new storage condition are to be tested have already been called	Manually create a new item in the testing schedule for the new storage condition. In the transaction for scheduling the maintenance plan (testing schedule), create a manual call for each test date that has been called on which the new storage condition is to be tested. Since two inspection lots now exist for the previously existing storage conditions for this date, cancel the unneeded inspection lots . This informs the scheduling function that no confirmation will occur for this call. The inspection lot is considered to be completed.
Storage conditions have been specified A testing schedule has been created A start date for the stability study has been specified (that is, scheduling has been triggered for the testing schedule) Dates on which the new storage condition is to be tested do not exist in the testing schedule	Manually create a new item in the testing schedule for the new storage condition. In the transaction for scheduling the maintenance plan (testing schedule), start the scheduling in the current cycle . If a date that lies after the specified completion date was already called before you executed the function Start in cycle , two calls now exist for this test date in the testing schedule. You must now manually cancel the unneeded, duplicate inspection lots for this date. Only one inspection lot should exist for each storage condition and test date, which has not been cancelled. By cancelling the unneeded inspection lots, the scheduling function is informed that no confirmation will occur for this call. The inspection lot is considered to be completed.