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Webinars Product Materials include all materials produced internally through manufacturing or production processes.
These materials typically undergo various stages of production to meet specific performance and quality requirements.
They are rigorously tested and validated at each production stage to ensure compliance with necessary regulations and standards.
Product Management Process
1
Material Record Setup
2
Batch Production
3
Material Units
4
Shipments
Material Record Setup Steps
Material records provide essential details about materials, ensuring they are accurately categorized, stored, and managed.
These records also offer the option to link library tests, helping maintain material quality control.
Step 1 - Create a New Material Record
Fill in the necessary material details
- Name: The name of the material.
- Category: Products.
- Subcategory: The subcategory of the material.
- GMP or non-GMP: Indicates if the material complies with Good Manufacturing Practices.
Packages Information:
- Container: The larger unit that holds multiple individual packages.
- Package: The individual unit that directly contains the material. Each package will have its own barcode.
- Packages in Container: The number of packages grouped within a single container.
- Amount in Package: The quantity of material contained within each package.
Storage Requirements:
- Storage Temperature: The required temperature for storing the material.
- Handling Instructions: Specific instructions for handling the material.
Bill of Material:
The bill of material (BOM) is a comprehensive list of all materials required to produce a finished product.
It helps manage inventory, plan, estimate costs, and ensure all necessary materials are available.
- Material Element: The individual materials required to produce the final product.
- Amount: The quantity of each material element needed for production.
- Material Unit of Measure: The unit of measurement used for each material element (e.g., units, grams).
- Cost: The cost associated with each material element.
- Level: The hierarchical level of the material in the production process.
Bill of Equipment:
The BOE provides a comprehensive list of all the equipment required to produce a specific material.
It serves as a central reference to ensure that all essential machinery and tools are available, properly tracked, and ready for use during production, thereby supporting efficient and accurate manufacturing processes.
Bill of material
Bill of equipment
Step 2 - Material Quality Review
New Material
Description: This is the initial stage for creating a new material record. Essential details about the material are entered, including the material name, storage requirements, amount, category, subcategory, and GMP status.
Purpose: To capture and document the fundamental details of the material for future tracking and management.
Quality Review
Description: In this step, the material record is sent for quality review. This involves checking and validating the details provided to ensure the material meets quality standards.
Action Required: To move the material to this stage, the user must add quality reviewers and click the “Send to Quality Review” button.
Purpose: To ensure the material complies with the necessary quality standards before it is approved for use.
GMP Material
Description: This step indicates that the material has passed the quality review, is now considered GMP-compliant, and is ready for use.
Purpose: To mark the material as compliant with Good Manufacturing Practices, ensuring it is suitable for use in regulated environments.
Inactive
Description: The material can be marked inactive when it is no longer required or used.
Purpose: To manage and organize the inventory by marking materials that are not currently in use, preventing them from being mistakenly used.
Cancelled
Description: The material record can be canceled if the material is deemed unnecessary or if there was an error during its initial creation.
Purpose: To remove or deactivate incorrect or unnecessary material records, keeping the inventory database accurate and up-to-date.
Step 3 - Link Tests
Linking tests enable the association of specific tests from the template library to ensure material quality.
Examples of tests include:
- 1-month interval
- Stability testing
- Microbial testing
- Density testing
Test creation involves using a template object, with each test producing a calculated result based on predefined conditions.
Click on the 'Link Tests' button located in the Lab Information tab.
Search for the relevant test and click on the plus button to add it.
Step 4 - Specify Tests Results
Users can determine the specified results for each test.
The expected results specified in this screen are derived from the predefined template test.
In case of changing the result, click on the 'Save Specification' button.
Batch Production
Workflow Stages
Preparation
Description: This is the initial stage where all the necessary preparations for the production process are completed. This includes gathering materials, setting up equipment, and meeting all prerequisites before starting production.
Purpose: To ensure that everything is in place and ready for the manufacturing process to begin.
Production
Description: In this stage, the material or product’s actual production occurs. The process involves transforming raw materials into finished goods according to predefined procedures and standards.
Purpose: To carry out the manufacturing process, ensuring the product is made according to specifications.
Complete
Description: This stage indicates that the production process is finished. All manufacturing activities are completed, and the batch is ready for review or further processing.
Purpose: To signal the end of the production process and prepare the batch for quality review, testing, or packaging.
Cancelled
Description: This stage is utilized when the production process is strategically paused, or a batch is redirected to a different course of action. This could be due to proactive quality improvements, adjustments in production priorities, or other considerations.
Purpose: To gracefully conclude the batch record, ensuring all actions are documented and aligned with the overall production strategy.
Batch Production Setup
1. Click on the 'New Batch Production' button.
2. Fill in the mandatory information and click "Save".
Mandatory Fields
- Title: The name or identifier for the batch record.
- Batch Number: A unique identifier for this specific batch. This number is critical for tracking the batch throughout its lifecycle and for traceability purposes.
- Material: The specific material being produced in this batch. The user can search for and select the material from the list, ensuring the batch record is linked to the correct material.
- Quantity Manufactured: The total amount of material produced in this batch. This field is crucial for inventory management and recording the correct amount.
- Start Date: The date when this batch’s production begins. This helps track the production process’s timeline.
- End Date: The date when this batch’s production is expected to be completed. This helps plan and track the production schedule.
Book a Resource
1. Select the desired resource.
2. Set the booking date and time.
Material Unit
Material units are essential for tracking and managing individual portions of product material within the system. Each unit is recorded with a unique ID, lot number, manufacture and expiry dates, storage requirements, and handling instructions. To maintain their quality, these units are stored under specific conditions, such as temperature control and designated locations, until they are used.
Workflow Stages
In Stock
Description: This is the initial stage where the material unit is logged into the inventory and available for use. At this stage, it is stored according to its specified storage requirements (e.g., temperature, location) and is fully tracked within the system.
Purpose: To ensure the material unit is appropriately stored, monitored, and ready for use, shipment, or other actions.
Used
Description: When a material unit is marked as “Used,” it indicates that the unit has been utilized in a process, such as production, research, or testing. The material is no longer available in inventory for future use.
Purpose: To track the material unit’s consumption and update inventory records, ensuring accurate stock levels and preventing the reuse of consumed materials.
Dispose
Description: The “Dispose” stage is used when a material unit is no longer needed or is expired, damaged, or unsuitable.
Purpose: To manage the safe and compliant disposal of materials, ensuring they are not accidentally reused.
Shipped
Description: When a material unit is marked as “Shipped,” it indicates that the unit has been sent out from the facility as part of a shipment, either to another location, a customer, or another department within the organization.
Purpose: To track the movement of materials out of the facility, ensuring that all shipments are recorded, monitored, and traced until they reach their destination.
Material Unit Setup
The “Create Units” button in the batch record allows users to generate individual material units based on the quantity manufactured during the batch process.
When clicked, this button automatically creates the specified number of units, each assigned a unique identifier.
These material units are then tracked individually in the system, enabling detailed management, storage, and distribution of the produced material.
Each material unit can be tested by determining the tests at the material record stage, ensuring that all units meet the necessary quality standards before further processing or distribution.
1. In the Lab Information tab, click on the 'Create Units' button.
2. The records for the material units were created during the production process.
Shipment
Shipments are crucial for managing the logistics and distribution of product materials within the system.
They serve as a central point for tracking, providing complete visibility and control over the dispatch process.
This ensures that materials are dispatched efficiently and that the distribution of finished products to customers is handled with precision.
Key shipping details, including destination, carrier, packaging, and delivery date, are meticulously recorded to ensure accuracy and on-time delivery, contributing to overall supply chain efficiency.
New Shipment Setup
1. Click on the 'Outgoing Product' button.
2. Insert all the necessary shipment details and click on the plus button to add shipment items.
3. Search the product for shipment and click on the 'Add Shipment' button.
Print Labels
The print label option lets users generate and print custom labels for materials.
This feature enables label customization by selecting specific fields and designing them as desired.
Once configured, the labels can be printed directly.
1. Click on print label button.
2. Set all the relevant settings and fields, and click the save "Template Button".
