These are exciting times for the Pharmaceutical industry, which is witnessing tremendous growth. Talking specifically about India, with over 10,000 manufacturing units of around 3,000 pharma companies working in full swing, the industry’s growth will only be on an upward trajectory in the near future. However, it is not going to be a smooth ride for the industry, which continues to be gripped by conventional challenges. Industry operators continue to face roadblocks such as strict regulatory requirements, sweeping healthcare reforms, cut-throat competition, unforeseeable market trends, an increasingly aware consumer et al.
These challenges have made it inevitable for the pharma companies to look for solutions to seamlessly link all departments, resulting in streamlined operations, maximized productivity, reduced costs and increased profitability, thus creating a need for ERP Solutions or pharmaceutical manufacturing software. An ERP system gives more transparency to their business, by integrating all the processes, such as planning, purchasing, sales, inventory, marketing, distribution, regulatory compliance etc., and allowing it to operate more efficiently and profitably.
While more and more companies opt for ERP implementations, we elaborate on seven benefits about the ERP implementation in pharmaceutical companies, based on the ERP modules for the pharmaceutical industry:
1) Formula Security: Falling in the process manufacturing type of industry, it is of paramount importance for pharma manufacturers to get their drug formulation accurate. Formula Security is thus a critical feature, as even the slightest of modification in the formulation can be hazardous. An ERP keeps a record of all the modifications saved, and immediately updates all the stakeholders about the changes, seeking their approval. The feature also comes with revision controls. At any given stage, only one version of the formula remains active, which is passed on to production reducing chances of errors or manipulations.
2) Regulatory Compliance: Meeting the regulatory requirements again is a non-negotiable requisite for the industry operators. Besides, it is also important to facilitate the business growth. An efficient ERP system ensures that the business meets the regulatory compliances such as FDA CFR Part 11. The ERP also aligns the formulation management with regulatory requirements to create a business model which adheres to all the industry norms as well as government regulations.
3) Material movement: An ERP system allows tight control over the movement of materials within the supply chain. It allows tracking of every raw material from receipt through finished product delivery. It has well defined QA and QC roles, such that the appropriate materials are sent for production and the inappropriate ones are rejected or sent for quarantine, with the concerned stakeholders being kept in the loop. The respective pharmaceutical ERP module also identifies the material to be used for production and manages waste.
4) Supplier management: It is of utmost importance in the pharma industry to procure raw materials from recognized suppliers who have the ‘Supplier Verification’ and provide safe materials. An ERP system checks for vendor recognition, and only accepts raw materials procured from the authorized vendors whose information is stored in the system. Alerts are automatically raised whenever there is a discrepancy, thus ensuring that only quality material is received from the verified supplier. 4) Supplier management: It is of utmost importance in the pharma industry to procure raw materials from recognized suppliers who have the ‘Supplier Verification’ and provide safe materials. An ERP system checks for vendor recognition, and only accepts raw materials procured from the authorized vendors whose information is stored in the system. Alerts are automatically raised whenever there is a discrepancy, thus ensuring that only quality material is received from the verified supplier.
5) Production: A pharma ERP for a big/small company ensures production is done as per the cGMP (Good Manufacturing Practice) norms. It maintains the pre-production records in the Master Batch Record (MBR), which are essentially written instructions for a specific manufacturing process for each unique formulation and batch size. These are maintained to check if the production is done as per the set industry standards and whether the quality assurances have been met. Once the production is done, the entire data related to the production process is stored in the Batch Master Record (BMR). The MBR and BMR can be compared for audit purpose and also to see if there is any deviation. Such deviations, if any, can be fixed through NC/CAPA.
6) Sales, Marketing & Distribution: A strong ERP aligns company’s sales, distribution and marketing activities and allows them to work in sync to achieve the desired results. It allows maintenance of customer records and history, creation of accurate sales quotations, sales orders and creation of marketing workflows. It also allows batch tracking and lot tracking while optimizing and improving other business processes simultaneously. The ERP also allows companies to monitor a batch or lot work-in-progress and deliver status remotely.
7) Reporting: An ERP system also allows Document management, which is a critical part of the entire process. As mentioned above, it is essential for pharma manufacturers to meet the stringent regulatory compliances. The regulatory bodies, at any time, may ask them to produce entire data related to every single process involved in production for audit purpose. ERP allows storage of information related to every module and gives real-time access to that information.
An ERP, hence, has become an integral part of every pharma manufacturer’s business going forward. BatchMaster ERP for Pharmaceutical Industry has all the aforementioned features and it caters to all the needs of your pharma manufacturing business.