The pharmaceutical manufacturing industry continues with its upward swing, owing to the rising chronic disease prevalence across the globe, and subsequently growing demand for medications. The growth has been further boosted by direct/in-direct factors such as constantly improving healthcare standards, rising awareness on ‘prevention being better than cure’ in healthcare, greater penetration of health insurance that helps patients meet the healthcare expenses, increased corporate spending and government-backed initiatives into R&D, technological advancement in treatment discovery, and expiry of various patents over the next few years. But as with any other industry, for pharmaceutical manufacturing too the growth brings challenges along with it.
The manufacturers continue to face roadblocks on multiple fronts. There are the strict regulatory requirements they have to comply with. Then there’s the need to adapt to the sweeping healthcare reforms, negotiate with the cut-throat competition, get prepared for the unforeseeable market trends, deal with an increasingly aware consumer, traceability and quality control challenges, et al. These challenges make things difficult for the manufacturers, and increase the complexity of the manufacturing process. This is particularly harsh on the manufacturers, who as it is have a lot on their plate.
Operating in an industry which is highly sensitive in nature, and which involves manufacturing of critical life-saving medicines and equipment, the pharma manufacturers need to ensure that they are conducting their operations in a hygienic and aseptic environment. This is where batch processing — which delivers high quality products ‘just in time’, keeps a check on waste, and ensures that each batch is produced as efficiently as possible — comes into the picture.
What is batch processing?
Coming straight to the point, the method of batch processing assembles the different constituents of a product through step by step processes. In this method of manufacturing, the raw materials move through the production line in batches, allowing room for a gap between steps throughout creation as a batch moves through. In batch processing, a subsequent batch can be processed only after the current batch has finished. In the overall process, there can be seven or more steps that are completed within the same number of equipment before a product is complete.
Talking in terms of pharma industry, various components of a drug come together for manufacturing through a step-by-step process in batch processing. Using this method, the pharma manufacturers can produce specific amounts of a particular product and then adjust their manufacturing priorities according to the changing demands of the market. The set-up costs are initially less expensive in case of batch processing, which is one of its obvious benefits. So is the fact that each batch is more easily tailored to be unique.
Batch processing allows use of more advanced machines/equipment to enhance the quality and capabilities of the product. Another important benefit of batch processing is that it doesn’t require the manufacturers to make constant adjustments to the machinery. The manufacturers can easily spot the batches with problems and make a new batch as a replacement. Additionally, it also helps improve production planning and scheduling.
Challenges of batch processing in pharma manufacturing
To begin with, in batch processing, it gets difficult to determine whether the plant, resources and employees are being optimized at 100 percent efficiency or not. Also, in batch processing, avoiding the costly downtime is a massive challenge.
Batch processing can be a bit tricky for the batch process managers too, as they face this mammoth task of maintaining overall control over the process. There’s a need for them to be completely flexible while allocating resources, delegating the responsibility downwards to shop floor staff, and maintaining overall control via real-time data and communication tools, etc. Then there’s the pressure for them to meet a ‘just in time’ production schedule, which places great pressure on every department to deliver as per the required deadline.
Testing to determine whether the final finished products meet quality and compliance standards is yet another challenge. There’s simply no substitute to this step, because lack of testing can ruin the whole batch of goods. Therefore, testing or quality checks throughout the manufacturing process are of paramount importance, and ensuring them a stiff challenge for the pharma manufacturers.
How an ERP improves batch processing?
A pharma ERP software offers many potential benefits to the pharmaceutical manufacturing companies, helping them deal with the challenges that make the manufacturing process complex along the way. To begin with, the flexibility a pharma ERP software offers allows the pharma manufacturers to better the productivity even with each separate batch having distinct parameters. Using such system, the manufacturers can produce every single batch at the best possible efficiency, while at the same time ensuring the most appropriate equipment are selected to best of their capacity based on specific parameters.
Best-in-class pharmaceutical software like BatchMaster’s pharma ERP support all types of batches – mix, fill, and assembly. This means that no matter what the process type is – be it mixing, filling, or assembling – it extends support to creation of batches for all types in no time, and also to all the production activities from batch creation, Batch Ticket printing, allocation, inspecting, quality checking, to finally closing. Batch Sizing is dynamically done based on weight, volume, availability of materials or such. It lets you prioritize and expedite batch jobs while reporting shortages of ingredients and materials in the course.
BatchMaster pharma ERP’s Runs functionality allows batch production during a continuous period of operation to be achieved in individual as well as independent workable batches. This essentially means that the manufacturers can know how many batch runs they need to achieve their target production. Besides, it also allows batches for intermediate steps to run parallel. Also its SuperBatch functionality allows them to execute intermediates and finished good together in a single batch, yet in the required chronological order. Then there’s also the provision for partially closing the batches for immediate shipment of urgent orders. Closing a batch can be checked by mandating execution of QC tests, inspections, and SOPs.
By-design BatchMaster’s Batch Processing allows following cGMP, as it restricts movement of material based on lot statuses. Generation of MBR and BMR is another important feature incorporated for the ease of Pharma Manufacturers. Batch Costs are accurately calculated considering WIP, Labor, Losses, Overheads, material costs, setup costs and more. Allowing production of well-labelled finished goods in different packaging sizes.
BatchMaster ERP also allows the pharma manufacturers to calculate the yield of a product when a batch is executed, against the planned yield which can be pre-defined. The measurement of planned and actual yield as well as costs allows the manufacturers to evaluate, maintain, and maximize the efficiency of the manufacturing process.
Some other prominent features of BatchMaster’s pharma ERP include batch inspection, support to rework of excess product into WIP, alternate finished goods, or even by-product for resale, multi-level batches,
ERP brings in automation
What a sound pharma ERP software like BatchMaster also essentially does is that it automates the processes, and frees up the staff at the shop floor for other important things. For ex: a pharma ERP’s automatic system checking can check the batch activity and materials, and the software can even allow the product batches that require sign off or corrective actions, to act accordingly. Besides, the software also records all activities and audits to a database for any future reference. The need for security and traceability for consumer products such as pharmaceuticals has never been this high before. And rightly so, a pharma ERP helps the manufacturers track the manufacture of batches from raw material to the finished article, thus fostering both traceability and transparency, and giving the manufacturers the ability to trace every product as quickly as possible if problems occur, and even for the audits.
BatchMaster’s BMR (Batch Manufacturing Record) and MBR (Master Batch Record) functionalities come in handy in this regard. BMR are documents that help manufacturers ensure quality and regulatory requirements are achieved, while MBR are general manufacturing instructions – a prerequisite for cGMP – which lay foundation for a precise, detailed description of a pharmaceutical manufacturing operation.
Furthermore, using a pharma ERP software, regulatory requirements can be addressed, and Formula bills of material (BOMs), packaged and batch entry BOMs, batch sheet and ticket processing, private label, custom orders, bills of lading, and other manufacturing processes can be simplified. In fact, a pharmaceutical software gives the manufacturers the ability to look beyond the regulatory requirements, and carry out incisive testing to gain more knowledge of the risks that possible contaminants could have on any drug being manufactured.
Conclusion: It is clear from the blog that for pharma manufacturers to deal with the challenges, and to improve batch processing, a tool as competent as the pharmaceutical software is a must. A flexible pharma ERP software not just helps them seamlessly link all departments and processes from sourcing, manufacturing to shipping, but also manage quality and compliance, streamline the operations, maximize productivity, reduce costs, increase profitability, and improve supplier relationships, among other things. BatchMaster ERP for pharmaceuticals helps the manufacturers integrate all the processes such as planning, purchasing, sales, inventory, marketing, distribution, regulatory compliance etc., and allows their pharma manufacturing business to operate more efficiently and profitably. Contact us today for more information.