What is cGMP?

cGMP stands for current Good Manufacturing Practice and, more than just initials, it is at the center of the US Food and Drug Administration’s efforts to protect citizens from potential hazards related to food and beverages, cosmetics, pharmaceuticals, and medical devices. ERP is the system used by businesses for accounting, inventory management, sales order processing and many other processes central to maintaining management control. ERP is where businesses keep the records that show they are complying with good manufacturing practice.

What does cGMP look like for manufacturers?

Process Control

Process control is critical in these controlled industries. We need to define exactly how our product flows through manufacture. Who will perform the necessary manufacturing steps? What ingredients or component parts are required? When does each step take place related to the previous and following steps? Where will we manufacture our products – in which facility and using which equipment? Why are we taking these measures to control our process? How will we document exactly what we did and compare it to what we said we would do?

Training

An ERP system has a record of each employee. That record goes well beyond payroll and human resources. If we add the training each person has had and their current work qualifications, we can use ERP to work with our cGMP process. We can now schedule specific people within our overall production schedule. The people scheduled are limited to only those who have required training and certification based on the rules we established within our business. Next we can use ERP to track exactly who worked on each manufacturing step. This enables us to pass any audits. We also now can know who might have made any error or failed to precisely follow our defined process.

Inventory

Our cGMP includes a specific list of ingredients or component materials required to produce our product. Our list can further limit the materials used to those from specific suppliers or items commonly available from multiple sources. ERP helps us track each item by lot number so that we never inadvertently mix a lot in the same batch. Lot tracking sets up our ability to manage any potential recall. We know which output batch had an issue and know exactly which ingredient lots we used in that batch. We can also use ERP to avoid any chance of using an item beyond its shelf life.

Recipe or Routing

ERP provides us with the manufacturing path that we know meets cGMP. Step one is performed on certain equipment and specified operations must take place then. We can measure the outcome of step one and ensure production is ready for step two. Since we know the duration of every step, we can schedule equipment and personnel and provide the completion date and time for our customer.

Facilities and Equipment

Our cGMP specifies that products must be made only in approved manufacturing facilities and then only using specifically approved equipment within those facilities. The production schedules we use from ERP will use those limits and help us manage capacity requirements now and in the future. Manufacturers must identify what hazards might exist and establish control points best suited to capture and control those hazards. This requirement is known as HACCP or Hazard And Critical Control Points.

Testing and Measurement

Throughout the cycle of production, we will test and measure the product using values stored in the quality module of our ERP system. The tools we use are maintained and recalibrated as we define in cGMP and our test results include the specific tools used as well as the results. Testing and measurement looks for statistically significant variances and enables us to determine corrective and preventative actions and track those to completion all within our ERP.

Quality Management System

cGMP requires that we have an active quality management system that is fully documented. ERP is one of our primary record keeping tools and supports cGMP fully. Any business whose activities fall under the cGMP rules of the FDA should ensure their ERP fully supports their required control systems.

Are you facing ERP cGMP regulation challenges?

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How the Right ERP Consultancy Can Take the Risk Out of ERP Implementation

Implementing ERP presents many challenges. One of these involves the simple dilemma of finding good help. Implementing ERP is not a one-man band, but rather a symphony of interconnected members, each doing their part in the performance. Your ERP consulting partner is one such member of the overall team and can significantly impact the success of an ERP implementation. With that in mind, here are a few considerations that will help you make the best choice when finding a consulting partner.

An ERP Consultancy Provides a Path of Success

Scope

At the beginning of your project, define what completion is and how to objectively measure the project’s completion. That definition might evolve as the project moves along, but it’s helpful to define your destination before you embark. This helps you understand how long you will need consulting assistance — completion means the consultant can move along to their next client. You will need to write that final check. Completion also means it is time for you and all the people in your enterprise to sit back and smile. Plan for that success.

Requirements

Consider the needs of your organization and the expertise you already have within your business. You might have a person you think is ready to lead your project: they have the skills and training, but a consultant could guide them and provide experienced mentorship along the way. Or, you might have a very lean organization and need to use a consultant as a full-time manager of the project and then plan to cut the consultant loose when the project is complete.

Culture

Culture is a very important consideration. The consultant who is successful working with a strict top-down leadership style will be different from a consultant who would succeed in an environment where each manager is independent and is expected to make decisions on their own. Your consultant must fit into your existing style and work well with your personnel.

Business Interaction

Negotiations with your consulting partner will begin with senior members of that organization. Those people might not be the same people who will actually work at your business with your own employees. Part of your agreement with the consultant should be control over consultant staff and their ability to get along with your employees.

Logistics

Provide your consultant with access to your systems, a place to sit, and an open communication line to everyone. Introduce the consultant to your staff and let people know who they are and the important work they will be doing on your behalf. Reinforce the call to open communications as needed throughout the project. Many ERP projects are a means of providing tools for future expansions or other plans that likely are confidential. Ensure the consultant understands and has signed appropriate non-disclosure agreements.

Change Management

You will hire a consultant that has the expertise to work with your business eventually to a successful completion of your ERP project. The relationship is not entirely technical. Your employees and system users all react to change in their own unique ways. Some will adapt quickly and embrace the new processes. Others will fight to keep the old process they are already comfortable using. Most will fall somewhere in between, neither fighting change nor immediately accepting change but will, in the end, use your new ERP system. A few might never accept the changes and will part from your business.

Managing change and helping your people along is one of the critical components of your ERP project. The ERP consultant you hire probably has the expertise you need in this area and you should take full advantage of it so your people can stay satisfied.

Data Management

Part of the ERP project will be data conversion from your legacy systems and loading that data into the new ERP. Many IT staff do not have the bandwidth to handle this work in addition to their current jobs. Often this work will be managed by your consultant. Consider who will handle data not only during the project’s duration, but also who will pick up the responsibilities thereafter.

Verification

As the project moves along, you will test specific transactions and the overall system to ensure the results meet your needs and expectations. Use your own people for some of the manual tests. Not only will they help with the project step, they will gain some training and become ambassadors representing all of your ERP users. The consultant will be a guide to setting up and managing testing. The consultant might have automated test processes too which will perform tests that follow your processes and repeat tests 24 hours a day. You will gain many additional test cycles and avoid human errors in testing.

Training

Think about how to train your people to use ERP when the project is complete. You can train a few to train the many and use your existing resources. You could also use the consultants to design and implement needed ERP training for you and your team.

Collaboration With Your ERP Consultancy of Choice

Fundamental to the idea of ERP is the notion of collaboration. Enterprise applications build bridges within the enterprise, and between the enterprise and the outside world. The act of implementing ERP is similarly an act of collaboration. In this light, when choosing a system integrator, ensure that they are an implementation partner, and not merely a consultancy for hire — for it is through people and partnership that the true benefits of ERP are realized.

Want to learn more about how an ERP consultancy can help your business?