Recently, a friend of mine, who owns a pharmaceutical company in the United Kingdom (UK), and I planned to meet for coffee. However, as usual, he got caught up with work and arrived late. When I asked him why his work seemed so chaotic, he explained that managing all the departments and the entire production scale in the pharmaceutical business is inherently challenging. I introduced him to the concept of ERP software as a potential solution to his supply chain management woes.
He was surprised to learn that an ERP solution could digitalize all supply chain operations and assist in simplifying processes, boosting efficiency, and improving productivity in his pharmaceutical company. Upon this, he asked what features should be looked for or what features an ideal pharma ERP software should have. Below is the list of six most important features that can’t be compromised while selecting a Pharma ERP:
1. Formulation/Recipe Management
Formulation management is crucial in the pharma industry, as a manufacturer's success depends on effective formula control, security, and tracking. ERP for pharma allows manufacturers to document every detail of each ingredient and its use in the production process. It tracks ingredient specifics, stores formulations securely, and incorporates an approval workflow for added security. It also ensures that only authorized personnel can access the formulas.
2. Batch Processing
Pharma manufacturing is performed in batches according to cGMP guidelines. Manufacturers need an ERP that handles the entire product line, including tablets, powders, capsules, and syrups. It should seamlessly manage the entire production process from batch creation to closure, including ticketing and cost calculation for materials, labor, and other expenses. Additionally, the ERP should be capable of printing BMR and MBR reports, monitoring batches, dynamically sizing them, and executing SOPs.
3. Quality & Regulatory Compliance
A good pharmaceutical ERP software ensures compliance with FDA 21 CFR, EU GMP, WHO GMP, and other standards. It includes workflows, approval controls, and audit trails to simplify compliance. It features quality assurance (QA) and quality control (QC) capabilities, along with stability testing, to ensure the safety of drugs reaching consumers.
ERP for the pharmaceutical industry should support QA testing, document the entire process and the outcome of each test, eliminate even the slightest slip-ups, and ensure conformance with expected standards. Well-defined QA and QC roles and compliance with cGMP mean that only the appropriate materials are sent for production or shipment while the inappropriate ones are rejected and quarantined, returned, or disposed of. NC, CAPA, Inspection plans, Adverse Event Reporting, etc., are other features that cannot be missed in a ERP solution.
4. Lot Traceability
A ERP system with lot traceability features enables manufacturers to track ingredients throughout the entire supply chain, from procurement to final sale and vice versa. This capability facilitates efficient management of recall situations and enables swift product recalls when necessary. It also allows the execution of mock recalls. By providing a 360-degree view of each product lot's activity, the ERP system ensures that each lot remains distinct and traceable in all subsequent operations.
5. Inventory & Material Management
A reliable ERP for the pharma industry enables manufacturers to minimize material wastage and monitor inventory levels effectively, ensuring greater profit margins. It facilitates identifying required materials, setting procurement triggers, and scientifically monitoring material usage. Additionally, it reconciles inventory balances and generates inventory status reports promptly. By calculating production and procurement needs, the system optimizes inventory levels to prevent overstocking or understocking. Furthermore, it supports the first expiring, first out (FEFO) approach to inventory management, ensuring consistent quality and minimizing the risk of selling expired products.
6. Procurement and Sales
The ERP software must support the entire Procurement and Sales cycle. Starting with opportunity maintenance, tracking, and analysis, to quote creation, order generation, picking, packing, shipping, and invoicing. It should allow applying different types of discounts, promotional offers, sales kits, etc., while also calculating country/state-specific taxes.
In the case of Procurement, manufacturing ERP software should maintain vendor details and certifications, suggest the best vendor based on quality, cost, lead times, etc., and should alert when a vendor certification is expiring. It should also digitize the quote-to-receiving process followed by the generation of Vouchers.
Conclusion
These are six major features that are MUST-HAVE for pharma manufacturing ERP Software. One such ERP software that encapsulates all these capabilities under its umbrella is BatchMaster ERP for Pharmaceutical. Tailored specifically for pharmaceutical industries, BatchMaster ERP offers a comprehensive solution designed to meet the unique needs of the sector.
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