Overview

A sample record is a digital document that captures information about a specific sample taken at various stages of pharmaceutical manufacturing. This record typically includes details such as sample identification, sampling location, sampling date and time, sample quantity, and any relevant test results. Samples are often collected to assess the quality and performance attributes of materials or products at different points in the manufacturing process. By maintaining accurate and detailed Sample records, users can track the quality of their products, identify trends, and make informed decisions to ensure product quality and compliance with regulatory requirements.

Steps

1. Log into your company’s Sandbox and navigate to an existing Project (this can be the project you created in a previous exercise or an existing practice project in your Sandbox).

2. Navigate to your Process

3. Open the Unit Operation you created in an earlier exercise

   1. See Creating Process Records if none exist

4. Name: Cell Culture

5. Type: In-Process

6. Timepoints & Events: Day 0 Post-Inoculation

7. Other Fields to complete:

   1. Matrix: choose a Material

   2. Number Of Aliquots: 2

   3. Amount: 1

   4. Amount Unit of Measure: mL

   5. Container: 15mL falkon

   6. Contact Material: PDE

   7. Storage Condition: 18-26

   8. Condition Unit of Measure: °C

   9. Storage Duration: 5

   10. Duration Unit of Measure: minutes

   11. Destination/Lab: Shopfloor

   12. Testing Site: On Site

   13. Sample Label: End of Medium Hold

8. Click Save Draft