02.004.02 Order Processing SOP

Pages: 14 1 of 14 SOP # Order Processing Version 02.004 2.0 Standard Operating Procedure Purpose This document describes how orders are processed, filled and inspected at Persona. Scope This procedure covers the processing of orders from customer care through operations. Orders are managed through the Business Central platform. Frequency This procedure is followed every time an order is processed. Safety When using incision tools be sure to cut away from hands to avoid a safety risk. To improve standing ergonomics, utilize the anti-fatigue mats that are found at all standing stations. When lifting heavy objects, practice safe lifting techniques as defined by OSHA. Responsibilities • Respective Department Managers are responsible for implementation of this procedure with staff on Nutrition, Operation and Quality ends. Materials • Computer • Back office/Business Central • TCGRx program • Bulk product • TCGRx canister • Quick fill canisters • TCGRx system • Canon printer system • Ship station • Booklet paper • Shipping label stickers • Incision tool • Correction stickers • Pill pouch rolls • Stainless steel bowls • Waste log • Indelible ink pens • Shipping boxes • Shipping sticker • Pill distribution paperwork

Pages: 14 2 of 14 SOP # Order Processing Version 02.004 2.0 Definitions • Operations includes receiving, sampling, dispensing, packaging, labeling (i.e. booklet information, website, etc.), boxing, and shrink wrapping. • cGMP: current Good Manufacturing Practices • NDC number: National Drug Code: combination of letters and numbers that coordinate to each unique stock of material between TCGrx canisters and quick fill canisters • TCGrx canister: the dispensing canisters within the TCGrx machine • Quick fill canister: The dispensing units used to re-fill the TCGrx canisters Procedure 1. CUSTOMER CARE: 1.1 Each day, a Nutritionist opens Business Central to identify new or reoccurring orders to be processed. It is required to process and fulfill orders within one business day. 1.2 Orders are placed in an order queue as they are received, and pills automatically distributed into specific pack types (AM, PM, Bedtime or Combo). 1.3 All new orders, and any reorders with adjustments or additions, are manually reviewed by a Nutritionist. 1.3.1 Unchanged reorders are processed automatically by the system per the customers subscription schedule. 1.3.2 For orders that require manual adjustment, the Nutritionist determines which supplements and how they should be distributed amongst AM, PM, or Night packs. 1.3.3 Once adjusted, orders are approved and sent to operations. OPERATIONS: Creation of pill bags using TCGRx/ATP machines 2. To begin this process, Internet Explorer MUST be used. 3. Make sure all network drives and printers are connected. See Below:

Pages: 14 3 of 14 SOP # Order Processing Version 02.004 2.0 4. Universal interface must have ‘TCG – file’ and ‘Auto Release’ box checked. See Below: 4.1 In the Business Central platform under the Pick, Pack, Ship tab – Process Orders section, the Dispense Manager identifies which orders to process. 4.2 Using date range and order type drop downs, Dispense Manager will split orders into batches 10/batch, per order type. See Below:

Pages: 14 4 of 14 SOP # Order Processing Version 02.004 2.0 4.3 Click “OrderID” to frame information from lowest to highest, which puts oldest orders first. See Below:

Pages: 14 5 of 14 SOP # Order Processing Version 02.004 2.0 4.4 Click “T”, which indicates if order has been sent to TCGRx. See Below: 4.4.1 If order has been sent to TCGRx, adjacent field will be populated with a “gear” icon. See Below: 4.5 Select Printer. See Below:

Pages: 14 6 of 14 SOP # Order Processing Version 02.004 2.0 4.6 Select orders to be sent in batch. See Below: 4.7 Check that there are no duplicate names. See Below:

Pages: 14 7 of 14 SOP # Order Processing Version 02.004 2.0 4.8 Click pill distribution 4.8.1 This pulls up the pill distribution screen. See Below: 4.8.2 Hold ‘ctrl+F’ on the keyboard and type in ‘do not’ to the search bar that shows up and hit ‘enter’ on the keyboard. See Below: 4.8.2.1 This will double check that all the pill distributions match as intended. 4.8.2.1.1 If distributions do not match, deselect from batch and alert nutrition of the error to be corrected. 4.8.2.2 Adobe Acrobat should display the message “Adobe Acrobat Reader has finished searching the document. No matches were found.” 4.8.2.3 Click ‘OK’. See Below: 4.8.3 Click the ‘print’ icon. See Below:

Pages: 14 8 of 14 SOP # Order Processing Version 02.004 2.0 4.8.4 Click the ‘print’ button in the new window that pops up. See Below: NOTE: Make sure correct printer is selected in printer window. 4.8.5 Close the pill distribution tab. See Below: 4.9 Click on the ‘Release Order to TCGRx’ button corresponding to the machine (A, B, C, etc.) that the order is intended to go to. See Below: 4.9.1 Via Windows Defender Security Center: 4.9.1.1 Under “Virus & Threat Protection” tab: 4.9.1.1.1 Ensure Virus Real Time Protection is OFF

Pages: 14 9 of 14 SOP # Order Processing Version 02.004 2.0 4.9.2 A command window will pull up with the window that says “The webpage you are viewing is trying to close the tab. Do you want to close the tab?” Click ‘yes’. See Below: **NOTE: MUST be using Internet Explorer Ver. 11.1304.17134.0** 4.9.3 A white window will pop up that says “To display the webpage again, the web browser needs to resend the information you’ve previously submitted. Click ‘Retry’. See Below: **NOTE: DO NOT CLICK CANCEL, this will cause problems in shipping**

Pages: 14 10 of 14 SOP # Order Processing Version 02.004 2.0 4.10 At the TCGRx Host workstation, operations manager selects and opens the Batch File. See Below: 4.11 Each order is selected and released to the client computer which operates the TCGRx. 4.12 From the client computer, batch files are selected. See Below:

Pages: 14 11 of 14 SOP # Order Processing Version 02.004 2.0 4.13 Click ‘process’, ensure order dispense direction is in reverse. See Below: 4.14 Click “next”. See Below:

Pages: 14 12 of 14 SOP # Order Processing Version 02.004 2.0 4.15 ‘Sort groups’ and ‘label groups’ are tied to facility so that they auto populate when facility group is chosen. Process batch according to label template. NOTE: Label group: puts info on front of pill bag that is dispensed and Sort group: indicates how the pill bag is allocated (i.e.- Combo bags will be alternating; Non combo (standard) will be on two different rolls. The screen to control this is in the TCGRx program. See Below: 4.16 Click, “finish” and then “dispense”. See Below: 4.17 The order is then filled by the TCGRx machine. The customer first & last name is printed roll header and footers, customer first name is on each pack. Each individual pack also contains specific supplement names, quantities, AM/PM/NIGHT icon, and TCG assigned BatchID. 4.17.1 The TCGRx machine will indicate if canisters are empty and need to be filled during the operation.

Pages: 14 13 of 14 SOP # Order Processing Version 02.004 2.0 4.17.1.1 All canisters are labeled with supplement name and NDC#. The same supplement lot may be added to the canister by operations during packing and then the TCGRx machine restarts.

Pages: 14 14 of 14 SOP # Order Processing Version 02.004 2.0 References • 21 CFR Part 111 • F01.001 Document Registry • F01.006 Document Template • OSHA Safety practices Attachments • F02.005 Waste Log • I-TD67-ATP Alarm Messages and Actions • Correction sticker template Document History Revision: Reasons for Change: 1.0 Original 2.0 Added Signature panel; Added definitions; Added QC process; added photos; added materials, added safety, added frequency.