The vast majority of FDA regulated companies still use manual systems for GMP manufacturing. While many are convinced their life could be simpler with an electronic manufacturing system, they are reluctant to make a change. We will talk about the guiding principles and a step wise process that can help bring about a change to a more efficient process for manufacturing using a manufacturing execution system with electronic batch records.

Step 1 – Planning

The first step in making a transition to electronic manufacturing is to assess your manual system. Find and identify the problems that you have with your current system. Each one becomes an opportunity for improvement after a transition. You can conduct a root cause analysis. This means taking the problems and writing a root cause statement for each one. Each of the cause statements can then be converted into a fundamental requirement which in turn can be used to create new manufacturing workflows that span your entire operation. Write the new workflow in a way that it can be incorporated into a master manufacturing record.

In an example of this process, a project manager or facility supervisor initiates a new project such as making a batch of tablets. The first step in the batch record is an operator checks the equipment logs to make sure the required equipment is clean and calibrated. The next step is to clear the rooms where production will be done. A supervisor can then sign off that is it is OK to start production. The operator then dispenses the components and updates the inventory system in real-time. Production then begins using the electronic batch records. When blending is done, a supervisor signs off that it is OK to continue to compression. Once the tablets are made the room is cleared, a room log is updated in real time to reflect the batch that was made there. The operator calculates the yields and a Quality Manager signs off and dispositions the batch. All of these process steps can be done collaboratively in the same manufacturing execution system.

Step 2 – Implementation

We suggest that you start your implementation with a small project and a small team to minimize any disruption to your normal operations. The team can be as few as two people and probably not more than five. Pick a single product or SKU that is representative of your product line and prepare a process flow such as the one in the example above. Make sure it spans all of your manufacturing activities and includes non-production activities such as dispensing, room and equipment inspection, in-process testing, calculations and room clearance.

Step 3 – Convert the First Master Production Record

The next step in the transition to an electronic manufacturing execution system is to take one master batch record from your manual system and convert it to an electronic Master Production Record. Here is where your start with the workflow of your entire operation. For example, you could start with checking out your rooms and equipment and recording their status in the room and equipment logs. If you have legacy systems that you prefer to retain, you can write instructions to integrate with those systems. Follow through to the actual manufacturing steps and finish at the disposition of the product.

The key concept is to capture all the activities throughout your manufacturing operation that can be conducted with a single system. This allows all of your staff to have access to all manufacturing information at any location that has an internet connection. This means that multiple people and multiple functions can be collected into a single workflow and can be accessed from different locations. The benefits include reducing redundant or overlapping activities and creating a more efficient work environment.

Step 4 – Pilot the Process

Once you have mocked up a process where each of the major functions have been incorporated, you can pilot the process by running a virtual batch as a demonstration. When your staff are comfortable with the demonstration, you can start working through the transition until the electronic batch records are fully employed. You can roll out the system to the rest of the staff and then implement it for each new SKU as they come up in the production schedule. It is at this point when all of the modules are working together that the entire electronic batch record manufacturing system can be made operational across all SKUs and the benefits of productivity enhancement, quality improvement and cost reduction can begin.

Rick Soltero, President of InstantGMP MES, an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com MES, an electronic manufacturing execution system that is web based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Author Bio: Rick Soltero, President of InstantGMP MES, an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite EBR, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Category: Medical Business
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record