Over the years, the bulk drugs, or Active Pharmaceutical Ingredient (API) manufacturing has undergone tremendous changes, thanks to changing technologies, regulatory requirements, and approaches towards manufacturing. The industry has also witnessed steady growth in recent years, and enjoys a healthy balance between growing demand and supply. For the uninitiated, bulk drugs are the active raw materials used in medicines to give them their curative effect. In other words, APIs are that part of any drug which produces its effects. Only a tiny part of the active ingredient- which produces the effect- is contained in the medicine. Some drugs even have multiple active ingredients to treat different symptoms.
But since issues the APIs are manufactured through a very complex process utilizing different processing technologies – by both chemical synthesis as well as physical means – the API manufacturers have quite a few pertinent to address. For the efficient manufacturing of high-quality bulk drugs, or APIs, manufacturers require a high degree of concentration. The process ranges from involving a series of experiments, quality control (QC) analysis in the testing laboratory to examine whether the API manufactured is pure, and quality assurance (QA) from the staff, confirming that everything has been performed correctly in accordance with cGMP from manufacturing of API, to quality testing.
An ERP for bulk drugs has provided ample support to the API manufacturers all this while. But with time, the need to make this process modern and contemporary has been felt. The manufacturers, quite rightly, are looking to adopt emerging ERP technology to modernize bulk drugs manufacturing.
The quality of APIs has always been under scrutiny, predominantly because of its significant effect on the efficacy and safety of medications, as poorly manufactured APIs can potentially cause serious harm such as illness, or even death, to the end users. This applies to both- the APIs that are manufactured as well as the ones that are outsourced. That is why APIs are subject to stringent regulations, and the bulk drugs manufacturers need to adhere to strict safety and quality standards set by both the country of production as well as end-consumption.
Then there are other challenges too for the manufacturers, as they also need to address increasing pressure to reduce waste and manage the by-products efficiently, deal with the cut-throat competition in the highly-fragmented market where patent expiry of branded products further results in expansion of generic sector, and make the supply chain more complex, among others.
In order to tackle these challenges, the API manufacturers seek the help of an ERP for bulk drugs- specifically a customized ERP for the API manufacturers, whose robust features allow the manufacturers to produce high-quality and cost-effective products, purchase raw materials from certified vendors, inspect multi-level production and synthesis process etc. Besides, it also assures the bulk drugs manufacturers comply with the necessary industry-specific regulations of labeling, specifications, lot traceability, FDA 21 CFR part 11, adverse event reporting, etc. apart from managing different areas of the business efficiently.
Why the need to modernize bulk drugs manufacturing?
The pharmaceutical industry in general, and the bulk drugs manufacturing industry in particular, is rapidly changing. Right from the technology to the manufacturing processes, bulk drugs manufacturers are opening up to the changes. Majority of them no longer handle every step of the drug-making process, from creating the API to building the capsule. These changes have forced the manufacturers to cut down on expenses and increase profits, and meet the newly emerged regulatory and legal standards so as to avoid fines or very expensive recalls. While the current ERP technology has enough functionalities to meet the present-day needs of the bulk drugs manufacturers, the same can’t be said for future challenges, which are only multiplying with time.
Increase in volume of business, change in technology, supply chain hassles, issues on the inventory management and warehouse front, and security of proprietary information, among other things, means the bulk drugs manufacturers will need to modernize bulk drugs manufacturing with emerging ERP software technology, by incorporating the latest technological innovations to their ERP for bulk drugs. Or simply put, they will require a modern ERP that can revolutionize the way they work, apart from helping them deal with the future challenges effectively & efficiently.
Modern technologies in API, and how ERP integrates with them
Artificial Intelligence (AI), Internet of Things (IoT), continuous manufacturing, 3D printing, industry 4.0, and blockchain, are some of the modern technologies/approaches in manufacturing in API businesses. These technologies are pretty much going to shape the future of bulk drugs manufacturing businesses. In pharma manufacturing, exacting precision is often a critical requirement. AI technology can come in handy there, facilitating a repeat of the same task at the shop floor hours after hours with the same quality and accuracy through robotics.
IoT, on the other hand, helps the bulk drugs manufacturers create a supply network with comprehensive, end-to-end visibility. Using this technology, many pharma manufacturing companies are shifting their products from batch to continuous manufacturing, while some other companies are establishing an integrated manufacturing process across their manufacturing plants. This path-breaking technology is also helping the manufacturers identify congestions among several processes within a plant, and determine whether any equipment is being overused or underused, thereby increasing operational efficiency.
There’s also the 3D printing technology, which allows making three dimensional solid objects from a digital file. The technology has been touted to emerge as one of the biggest game changers in pharma manufacturing, with its scope covering drug dosage forms. Another possible technological change in the API manufacturing landscape is Industry 4.0, or the ‘fourth industrial revolution.’ While the first industrial revolution was marked by mechanical production, the second was about mass production, and third about IT and automation; ‘Industry 4.0’ will be about machine-to-machine communication via the industrial Internet of things (IIoT).
Then there’s the Blockchain technology, which has a widespread application in the bulk drugs manufacturing industry. The manufacturers can digitally document every single movement of the product in the supply chain, and enjoy benefits such as real-time tracking of the products, reduced time delays, costs, and human errors, decreased cases of fraudulence, and improved transparency and security of proprietary information.
To sum up
Sooner than later, these technologies are going to become mainstream, which means the world of bulk drugs manufacturing will never be the same again. However, these technologies alone won’t prove to be the Gamechanger for API manufacturers. In fact, it is their integration with the right ERP for bulk drugs that will help the API manufacturers evolve with the changing times, and deal with the mounting challenges as well as complexities. A modern, and flexible ERP for bulk drugs/API like BatchMaster is exactly that solution, which will help stay the API manufacturers ahead in the game with its robust features and industry-specific modules.