Production Constraints

The Production step tells Prognosis how your kits are manufactured: how long a production run takes, how large a run can be, how often runs happen, how much buffer stock to plan, and which production lots are already agreed with your manufacturer. Clinical trial supply managers fill it in after the Treatment step, and the forecast uses it to generate recommended lots and plan when they must start.

Every card in this step saves automatically as you edit. There is no draft and no separate save button.

Before you begin

• Define your kits in the Kits step. Per-kit settings, kit overrides, custom lots and kit switches all list the kits from that step.
• Add at least one central depot in Country & depots. Custom lots must arrive at a central depot, and Add Lot Configuration stays disabled until one exists.
• To assign custom lots to label groups, create them in Label groups first.

Set manufacturing and production settings

The Manufacturing & Production Settings card holds the timing and size of production runs.

1. Choose how the settings apply with the selector in the card header:
   • All Kit Types — one set of settings for every kit.
   • Per Kit Type — one tab per kit, each with its own lead time, quantities, frequency and Optimize switch. When you switch to this mode, each kit starts from the values you had entered for all kits.
2. Enter the Production Lead Time and pick its Lead Time Unit.
3. Optionally enter a Minimum Production Kit Quantity and a Maximum Production Kit Quantity.
4. Either turn on Optimize, or leave it off and enter a Production Frequency with its Frequency Time Unit.

Important: Switching from Per Kit Type back to All Kit Types removes every kit-specific production setting. Prognosis asks you to confirm first, and the change cannot be undone.

Plan placebo runs with blinding

Turn on Blinding in the card header when an active or comparator kit needs matching placebo production runs.

1. Switch Blinding on. The Set up blinding production dialog opens.
2. Select the active or comparator kits that need matching placebo runs, then click Apply.
3. To change the selection later, click Configure next to the switch.

Note: Blinding is unavailable until the trial has at least one kit of type active or comparator. Demand for kits you already defined as placebo stays tracked and is not duplicated.

Configure safety stock

The Safety Stock Configuration card sets the overage and seed the forecast adds on top of dispensing demand. Choose how it is set with the selector in the card header: Global, Per Country or Per Depot.

• Overage is a percentage added to the kits dispensed. An overage of 15% on 1,000 dispensed kits adds 150 kits.
• For a trial with a local depot, the card notes that stock held at local depots is already planned for: depot planning sizes production to fill those depots, so use overage for anything else, such as loss or extra safety.
• Seed is a number of kits per kit type placed at each site as initial stock. It is an amount of kits, not a percentage.

Important: Changing the safety stock unit clears the values entered under the previous unit, including its kit-specific overrides.

The card also contains Only replace expiring seed when there is patient demand, which applies to every unit. With it on, an expiring seed kit is replaced only if the same kit is still dispensed in that country on or after the expiry date. Turn it off to keep replacing seed until the country's last visit.

Note: When Site Shipments is on for the trial, the Loss Rate card replaces this card. See Set a kit loss rate.

Global safety stock

With Global selected, one pair of values applies across the trial:

Override values for individual kits

Under Kit-Specific Overrides, click Add Kit-Specific Override, pick a kit, and enter its own Overage Percentage and Seed Amount. Kits without an override use the default values above. Overrides are available in all three units, and each kit can have only one override per global setting, country or depot.

Per-country safety stock

With Per Country selected, the card lists every country in the trial. Enter an Overage Percentage (0 to 100) and a Seed Amount for each, and add kit-specific overrides per country if needed. New countries start at 0.

To reuse one country's values, click the copy icon on that country and pick the target countries in the Copy safety stock config dialog. The country's overage, seed and kit overrides are copied.

Per-depot safety stock

With Per Depot selected, the card lists your Central Depots and Local Depots. Enter an Overage Percentage (0 to 100) and a Seed Amount for each depot, with optional kit-specific overrides. Use the copy icon in the same way to copy one depot's values to others.

Add custom lots

Custom lots are production runs you have already agreed with your CMO or production team, with fixed quantities and dates. They appear in the Fixed Future Productions card and are optional. Recommended lots then cover whatever demand your custom lots leave, within your production settings; when custom lots cover everything, no recommended lots are needed.

1. In the Fixed Future Productions card, click Manage Lots.
2. Click Add Lot Configuration. The Edit Lot Configuration dialog opens.
3. Enter the Lot Number and, optionally, a Description.
4. Pick the Central depot the lot arrives at. If only one central depot is valid, it is chosen for you.
5. Set the Manufacture Date, Ship Date and Expiry Date.
6. Under Pack Types, choose a Kit and its Quantity. Click Add Pack Type to put more kits in the same lot. All pack types share the lot number, dates and central depot.
7. For each pack type, choose Label Groups, or leave it as Unlabeled (all countries).
8. Click Save Changes.

From the lot table you can edit, duplicate or delete a lot. To remove every lot, click Delete All next to Manage Lots on the card.

Label group rules for each pack type:

• Unlabeled (all countries) — the kits can serve every country.
• One label group — it holds the whole quantity.
• Two or more label groups — enter a quantity for each. Every quantity must be a whole number greater than 0, and together they must add up to the pack type's quantity. The dialog shows how many kits are left to assign.

Note: Custom lots are for future production. If you enter a manufacture date or ship date in the past, the dialog suggests recording the stock in Actuals instead, where on-hand inventory belongs.

Important: A custom lot cannot contain a kit that is locally sourced in every country, because that kit never moves through a central depot. Remove the pack type or change the kit's local sourcing before you continue.

Define kit switches

A kit switch replaces one kit with another partway through the trial, for example a new formulation. Switches are optional. Add kit switch is available once the trial has at least two kits.

1. In the Kit Switches card, click Add kit switch. The Configure Kit Switches dialog opens with a new switch.
2. Choose the Treatment arm the switch applies to, or All arms.
3. Choose the kit under Switching from and the kit under Switching to, each with a Qty.
4. Choose the Type of switch:
   • Time-based — enter a Switch date. The source kit stops the day before and the target kit starts on that date.
   • Upon depletion — pick the Final lot for source kit. The switch happens when that lot is projected to run out. The most recently released lot is marked Recommended.
5. Under Where this switch applies, choose All countries, By country or By region (shown when regions exist), and select the countries or regions.

Switches save automatically. A switch is not saved while it is incomplete, and the dialog shows what is missing; if it was saved before, its last complete version is kept until you finish the edit.

Note: Upon depletion works only when the source kit has at least one custom lot. Add one in Fixed Future Productions first.

Set a kit loss rate

The Loss Rate card appears when Site Shipments is on for the trial. With it off, the step shows the Safety Stock Configuration card instead. A line at the top of the step says which one the trial uses, with Manage add-ons to open Settings → Add-ons, where it is switched; see Site Shipments add-on.

When the Loss Rate card is shown, it replaces the overage and seed inputs. Overage and seed are then calculated from your Site Shipments plan: overage is the stock left at sites and depots at the end of the trial, expired kits, and kits lost in transit.

1. Enter a Study loss rate: the percentage of every site shipment that does not arrive because kits go missing, are damaged or have a temperature excursion. 0 means no loss is modeled.
2. Optionally turn on Loss rate per kit type and enter a rate for individual kits. Kits you leave blank use the study rate.

Each rate must be at least 0 and below 100.

Reuse production settings as a template

Use the buttons at the top of the step to share settings between trials through Master data:

• Save productions as template… saves the step's settings to Master Data. In Per Kit Type mode you choose which kits' production settings to include.
• Load productions… replaces this trial's global settings, per-kit production settings, country and depot overrides, kit overages and blinding kits with a saved template. Custom lots are not affected. Kits, countries or depots in the template that do not exist on this trial are skipped, and Prognosis tells you how many.

Continue to the next step

Click Continue to save any pending edits and mark the step complete. Continue is blocked while:

• a required field is missing or invalid, including the lead time, production frequency and, in global mode, the Global Overage Percentage
• a maximum production quantity is set to 0
• a custom lot contains a kit that is locally sourced in every country
• a custom lot's kits are not fully split across its label groups
• a loss rate is outside the allowed range

If a custom lot, kit switch or loss rate edit cannot be saved when you click Continue, the step stays open and names the card to check.

The step does not run the forecast while you type. Analytics re-runs it when you open the dashboard after inputs have changed.

Related guides

• Shipments — the next wizard step, where you review DNx cut-offs and shipment policies.
• Label groups — create the label groups you assign to custom lots.
• Actuals — record on-hand inventory and historical data instead of custom lots.
• Supply and demand analysis — see how recommended and custom lots cover demand.