Training, experimenting, testing and documentation are the cornerstones of Good Manufacturing Practices.
However, mistakes and oversights can occur during their processes. When that happens, the results can negatively affect the manufacturer’s database resulting in compromised products, invalid documentation, regulatory fines and other concerns.
To help manufacturers avoid these unpleasant scenarios, InstantGMP, one of industry leaders in GMP software, has developed two advantageous products: the Sandbox and Make To Order Batch Records.
In the following article, we’ll explain the role these two products play in the manufacturing industry, highlight their key benefits and extend an invitation to see a demonstration of these invaluable resources.
What Is The InstantGMP Sandbox?
When our customers invest in our InstantGMP PRO software, they often want to purchase an additional version of the software that is completely blank.
Why?
These customers are looking for a safe space where they can “play around.” Essentially, they want a version of the software that allows them to text, experiment, and train without consequence.
The InstantGMP Sandbox makes this possible.
Our Sandbox product is a version of our InstantGMP PRO software that is completely blank. It’s a solution that provides manufacturers with a place to “play” in the system without adding unofficial information to the official database.
The Benefits Of The InstantGMP Sandbox
As a start-from-scratch GMP software solution, the Sandbox supports new users with a place to better understand how the all-in-one manufacturing and quality system operates. Primarily, it allows manufacturers to experiment without fear of consequence.
In the sandbox, manufacturing facilities can:
- Train new hires without worrying about their mistakes affecting official documentation, processes, or final production.
- Learn how to enter, configure and make different variants of materials without contaminating the official instance.
- Securely enter unofficial data for training and testing purposes without concern of it being accidentally reviewed by regulatory authorities or auditors.
- Safely collaborate with white label customers without compromising the official data.
In addition to these benefits, the Sandbox is also an invaluable resource for GMP software validation.
When customers purchase our InstantGMP PRO software, we provide that with a Performance Qualification (PQ) Test Script. Using this PQ test script, the customer can perform the validation process in the Sandbox. This permits all of the data that is collected as part of the validation process to be safely isolated from the official information.
The Sandbox supplies manufacturers with a pure environment for the validation process to be conducted in a way where there is no possibility of previous data influencing the outcome. In essence, the Sandbox ensures that the purity of the information stays intact during the validation.
While the Sandbox provides a safe, blank slate for users to train, experiment and test without negatively impacted their database,
What Is The Make To Order Batch Record Feature?
In paper-based systems, manufacturers must record every step taken during their Master Production Record (aka MPR or Master Batch Record) creation process. Every time a new experiment commences, they carefully document every step and element of the batch production record process, including the various materials (and exact measurements) incorporated in the formula, each piece of equipment used in the build process, and the duration of certain steps, etc.
Every time a change is made in the building and testing phase, the batch production record process starts all over again from step one. So does the documentation process.
This traditional recording process is incredibly time consuming. Every time a new experiment begins, a new document needs to be created to record each step of the process. Most of the time, these are filled with lots of the same information. Plus, when the final experiment breeds an approved result, that information has to be recorded in a new document to create the MPR.
Instead of continuing with this tedious process, InstantGMP developed a more efficient and effective method of recording the MPR creation process: the Make To Order Batch Record.
With the innovative and user-friendly Make To Order Batch Record interface, operators electronically record and revise the MPR development process on the fly in real time.
The Benefits Of Make To Order Batch Records
Similar to the Sandbox, the Make To Order Batch Record feature provides manufacturers with a dedicated space where they can more easily test and experiment.
Along with eliminating the need for numerous rounds of manual documentation in multiple physical notebooks, the Make To Order batch Record interface also offers additional benefits.
Since they have access to a full database of information, operators can develop new MPRs by accessing and incorporating existing processing steps and ingredients from existing Batch Records. This not only removes the need to physically rewrite the same information over-and-over again, it also allows operators the opportunity to mix and match the various process pieces to test, experiment and develop a final MPR.
This benefit is especially important for pilot plants in pharmaceutical environments. Since they are starting from scratch, these manufacturers do not know what the exact process is. At this stage they don’t know the order of ingredients to incorporate into a batch, how long to mix the ingredients, or other steps of the process.
To design the process, they test different materials, use varying measurements, select appropriate equipment, adjust mixing times, sequence process steps, and more until they are satisfied with the results. Then they can use the approved process from the Make To Order Batch Record to create the MPR.
Having access to existing batch records and the ability to incorporate previous process steps and elements into their development phase allows manufacturers to lay a foundation for a successful final product.
Another benefit of the Make To Order Batch Record are the built-in safeguards that ensure greater accuracy. The interface includes prompts that alert operators to skipped steps and vital missing information.
The Make To Order Batch Record feature is also an especially helpful tool for White Label Manufacturers. With Make To Order Batch Records, private label manufacturers can invite their customers to review the test batch process. This gives their customers a clear picture of how the product is made before it’s committed to final production.
During the review process, the customer can also approve or reject the test batch record. If approved, the manufacturer can save the final draft as the MPR. On the other hand, if the test batch is rejected, the Make To Order Batch Record process can continue until it develops an acceptable batch.
As we mentioned before, the Sandbox and the Make To Order Batch Record feature both help manufacturers more easily experiment, test and develop processes. Yet, they have one major difference: while the information entered and collected in the Sandbox is not part of the official database, all of the records and processes created in the Make To Order Batch Record feature do live in the official database. Although Make To Order Batch Record information cannot be deleted from the system, it can be safely hidden to prevent potential issues.
Two Great Features For Manufacturers
As you can see, the Sandbox and the Make To Order Batch Records features each offer something different for manufacturers. One provides manufacturers with a blank slate to safely learn their system and test processes, while the other effectively and accurately improves the traditionally time-consuming and problematic MPR creation process.
While we’ve shared some of the key benefits these products offer, there are many more perks that can help manufacturers, food and cosmetics producers, and formulation and development groups.
To learn more about the Sandbox, the Make To Order Batch Record interface, InstantGMP PRO or any of our software solutions, please contact our team today to schedule a demonstration!