In the present times, there are a number of challenges that threaten to bog down the pharmaceutical industry, which has achieved colossal proportions with its operations spreading to the manufacturing of drugs, vaccinations, and medical devices, among others. The industry faces numerous business challenges such as heavy regulatory requirements, radical healthcare reforms, an informed & demanding consumer base, volatile market trends, traceability and quality control challenges, and tight global competition.
In such times, it has become imperative for the pharma manufacturers as well as the private labelers or so-called contract manufacturers, to maintain the highest quality standards across all processes, and create products of supreme quality at compelling prices. To achieve this objective, the manufacturers need to have a system in place that throws accurate, actionable information in time, centralizes management, quickens decision making, and helps reduce costs, streamline operations and maximize efficiency. Such a system must also help improve the manufacturing processes in general in addition to patient safety, quality, and hygiene standards, etc.
Pharma ERP software perfectly fits the bill
An enterprise resource planning (ERP) system emerges as the system that helps the pharmaceutical manufacturers meet the aforementioned needs. It impeccably links all the departments, integrates all the internal processes, and automates all the key functions. Not just this, the ERP also helps manufacturers keep a track of sensitive operations across the organization, such as compliance, expiry management, quality, formulation, costing, yield and more. Consequently, the pharma manufacturing businesses operate at greater levels of efficiency and profitably.
Acting as the central nervous system of the pharma manufacturing unit, an ERP system interconnects the autonomous processes such as planning, procurement, inventory, sales, marketing and production among others; gathers real-time data from all departments, provides one centralized & secure repository, and through it makes the data accessible to other departments so that it can be used productively. This seamlessly syncs all the departments enhances transparency in operations and facilitates the smooth functioning of the entire pharma manufacturing unit.
While an ERP system can serve each industry’s requirements, it can help the pharmaceutical manufacturing industry meet its unique requirements. There are many ways how it can serve the pharma industry, but here are five predominant ways through which an ERP system can help pharmaceutical industries. Take a look:
Through effectively managing formulation: In any process manufacturing industry, and more so in the pharma manufacturing industry, formulation management holds great significance. A formula is developed after intense research and hard work, and thus it is imperative that it is managed efficiently. And that, actually decides whether the business is successful or not.
An ERP system for pharmaceutical manufacturing helps manufacturers manage all the essential aspects of formulation, including storing, retrieving, and securing every formula used in the business, and maintaining countless manufacturing instructions. Through its functionalities such as, formula security, patenting, formula approval, formula sizing, multiple packaging of the same formulation, etc., a pharma ERP software can help pharmaceutical industries immensely.
By helping meet regulatory compliance: For pharmaceutical manufacturers, it is absolutely mandatory to meet the industry, environmental, and regulatory requirements. And a pharma ERP software helps in this regard; as it ensures that the business follows cGMP and meets all the local & global regulatory compliances such as the FDA CFR 21 Part 11, Bio-terrorism, etc. With its features such as workflows, execution of SOPs, customer-centric COA, approval controls, generating BMR plus MBR and audit trails, it makes meeting compliance easier for the pharma manufacturers by helping create a business model which adheres to all the industry rules and the government regulations.
Helping with Quality Control & Traceability: It is important for the pharma manufacturers to ensure that the products they manufacture are completely safe and fit for consumption, and are of top quality. To ensure this, they also need the capability to quickly identify where, when, and what goes wrong at their manufacturing plant, and fix it. What they need is a pharma ERP software with strong Quality Control (QC) that allows defining tests, drawing samples as per industry defined norms, double testing, storing test results in numeric, alphanumeric as well as pass/fail format, among others. The QC module ensures full conformance with cGMP by allowing only the appropriate materials to be sent for production, while rejecting & sending the inappropriate ones for destruction, scrapping, return, etc. that too in the best of way along with their proper documentation. NC, CAPA, adverse event reporting, etc are other important aspects handled by an ERP perfectly.
Also, the ERP system allows the manufacturers to trace and track ingredients all the way through the supply chain from procurement to final sale and enables swift product recalls through its bi-directional traceability functionality.
Through material & supplier management: A good pharma ERP software helps manufacturers identify the quantity of material required for production, and set targets, and create triggers for purchase and replenishment. Through its state-of-the-art features, it allows monitoring material usage scientifically, reconcile inventory balances, and cut down the instances of material wastage.
Additionally, an ERP system for pharmaceutical manufacturing allows the manufacturers to procure raw materials from only the recognized suppliers who have the ‘Supplier Verification’ and restricts buying material from vendors whose certifications are nearing expiry or have expired. This way, not only the high quality, and safe materials enter the system, but a lot of documentation work is reduced in each deal.
By providing support to sample management, clinical trials, and commercialization: It’s a known fact that extensive clinical trials, rigorous sample testing, and long product life cycles, etc. are an integral part of the pharma manufacturing process. Keeping a record of these samples manually is simply not possible, as it could lead to costly errors. An ERP system for pharmaceutical manufacturing allows maintaining such records and trial histories in a centralized database that can be accessed anytime, especially for reference use and audit purpose. Moreover, ERP also provides complete sample management of samples sent to the customers. Right from getting specifications for samples, communication with the customer, it’s costing, tracking, approval/rejection, an ERP handles all.
Similarly, we are aware that a lot goes into researching and developing a drug, and the manufacturers often find it difficult to get approval for the same. Post-approval, the preparation for its market launch begins. Thus the pharma manufacturers rely upon a system that can manage these complex, multi-layered processes involved in launching a product. And that system is a pharma manufacturing software, which provides support to commercialization, and to all the processes such as manufacturing, sales and marketing, production planning and quality management, among others.
As the markets continue to shrink, pharma ERP software have become an indispensable part of pharmaceutical manufacturing businesses. Though they help pharmaceutical industries in more ways than one, we discussed in this blog the five most important of those ways. If you own a pharma manufacturing business or do contract manufacturing, and are looking to re-engineer your processes to maintain quality in the wake of existing challenges, getting an ERP system for pharmaceutical manufacturing onboard is the key to scale and grow your business. Experts at BatchMaster Software can help with one such software.