The challenges pharma manufacturers face today reflects the rapidly changing dynamics in health research and the strict regulations they must adhere to - which increases the complexity of the batch production process.
A completely sterile, aseptic environment for pharma manufacturing is vital, especially when producing oncology drugs or when active ingredients are involved. Where operators are needed with a specific batch manufacture the parameters for the aseptic process will need to be adjusted, the system in place will need to be able to help them manage this.
Testing and identifying whether finished products meet quality and compliance standards is also a challenge because if at any stage of the process or components is compromised it could ruin the whole batch of goods. Therefore testing or quality checks throughout the manufacturing process are needed.
Having a system will provide the ability to carry out deeper testing and look further than the regulatory requirements, to gain more knowledge of the risks that possible contaminants could have on any drug being manufactured.
Here are some of the ways Pharma ERP Software can help improve batch processing for pharma manufacturers:
1. Improved productivity
ERP software allows the flexibility for batch manufacturers and can improve productivity even when each separate batch has different parameters. Pharmaceutical manufacturing software will help produce each batch at optimum efficiency, ensure the appropriate equipment can be selected based on specific parameters, and this can be automated and changed per the ingredients and sterility requested.
2. Manual or automated
Batch manufacturing ERP software can automate processes and assist operators in their work. For example, operator checking can be used to standardise processes throughout manufacture while checking batch activity and materials can be done using automatic system checking. Product batches that require sign off or corrective actions, the software will allow for. It will also record all activities and audits to a database, so it can be referred to when required.
3. Traceability and transparency
With recent food fraud scandals, it highlights the need for security and traceability for consumer products such as Pharmaceuticals. Using a software to track the manufacture of batches from raw material to the finished article will give both full traceability and transparency. This is very important if recalls are necessary, to be able to trace every product as quickly as possible if problems occur - and it could be useful for audits.
Finding the right solution
The way to deal with these challenges is to invest in a system that is as flexible as the manufacturing procedure requires, help manage quality and compliance, and supplier relationships. When deciding evaluation is key - list the key challenges you want the new system to help you resolve first, before looking at the pharmaceutical ERP options on the market.
WinMan is a comprehensive all-in-one Pharma ERP software which helps you continually improving, streamlining and developing business processes, increase productivity and maximising return. Contact us today for more information.