A few weeks ago we asked, “Is your vendor committed to your industry?” Today, I would like to address an industry, and the MOM vendors within, where the answer is almost always yes and look at the reasons why. That industry is pharmaceuticals.
Every MOM vendor, and most other software vendors, claims to cover a variety of manufacturing industries. The definition of industries varies wildly, mostly in terms of the level of detail described. To use an extreme example, one vendor might say "we cover discrete manufacturing" while another might say "we cover tier one automotive and aerospace and defence (A&D) suppliers." The first vendor might have excellent knowledge of A&D manufacturing; the second almost certainly will. You need to ask the right questions to ascertain whether the breadth and depth of experience and expertise will suit your needs.
Pharmaceutical manufacturing would, at first glance, appear to be an industry where MOM vendors are likely to be highly specialized and have experience in an industry which is highly regulated. However, when we start to look at the manufacturing of a drug, ignoring development and trials in this simplified example, we see that the processes cover a very broad range including:
- Large scale batch processing with very complex control for chemical synthesis of active ingredients
- Batch mixing for finished drug preparation
- Weighing and dispensing
- Pill making
- Packaging, including serialization
All these processes have to be managed under strict regulation and reporting. This is imposed by the FDA and other national and international regulators. Many also need to be carried out in a clean environment.
When we look at the vendors of control systems and MOM software in the industry, it is not surprising that some specialize in only a part of the whole process. Companies that are strong in other process industries will often concentrate on the batch processing at the early drug making stages. The control systems will often be DCS based, and the MOM software focused on managing batch performance and records created from automatic recording.
At the other end of the process, things are much more manual and discrete. It’s often using specialized machines with embedded PLC control. There is an equal need for electronic batch records (EBR), but much of the interaction with the MOM systems will be manual. It is at this end of the pharmaceutical manufacturing chain that we start to see specialized companies that can deliver out-of-the-box functionality such as:
- Electronic batch records
- Weighing and dispensing
- Serialization for anti-counterfeiting - You will need loads more than just the MOM, bit of course
- Lot management
- Packaging and labelling
- Quality management and full 21CFR Part 11 compliance (often the validation services needed to get regulatory approval for EBR)
Pharmaceutical manufacturers may need to consider separate vendors for batch and finishing processes. Certainly it should be done at the control level and then perhaps at MOM level, too. It is not uncommon in the pharmaceutical industry to have a single active ingredient plant acting as a global supplier to multiple finishing plants closer to the customer. Sometimes it’s in a specific legal jurisdiction for regulatory reasons. When deciding the scope and placement of MOM and EBR systems, this geographical topology and different functionality need to be carefully considered. It may be best to consider a standalone on premise MOM system for the process plant. This is so process focused functionality, like process analytic technology, can be managed close to the process. However, the EBR functionality and the execution capabilities required in the multitude of finishing plants are much less time critical.
A business might find it much more useful to have low level control of packaging lines handled by simple HMI, for example. While the business critical EBR, job dispatching, and control could be managed by a centralized MES system, perhaps in the cloud. A few years ago few pharmaceutical companies would have considered a cloud or even centralized MOM and EBR solution. Today’s technology, and network speed and reliability, make it a real possibility. There are some real advantages:
- Centralized management of completed EBRs
- Cost effective and effective maintenance
- Easier validation
Although this example is for a single industry, the thought processes that go into deciding what are the options for control and MOM architectures apply across all industries. As we have seen, there are many parts of a pharmaceutical solution that are rather specialized, especially implementation and validation. In any industry there will be specialized functionality. It is this, and a detailed understanding of the specific manufacturing issues that make it so important that your vendor is both committed to and an expert in your industry.