Tailor-made solution for streamlining the nutraceutical operations

Regulatory agencies are tightening control over nutraceutical manufacturers to adhere to cGMP guidelines and other regulatory requirements while performing their manufacturing operations, so as to safeguard the consumer’s interest. Sweeping healthcare reforms, cut-throat competition, unforeseeable market trends, stringent manufacturing standards, and an increasingly aware consumer, who expects nothing but quality, are some of the other challenges they need to deal with. 

Under this scenario, to remain profitable, the nutraceutical manufacturers need to make cost-effective yet high-quality products to outlast the competition. This has prompted them to use advanced software technologies like ERP to streamline their business needs, optimize the production as processes, and comply with the regulatory norms.

BatchMaster ERP for Nutraceuticals understands the needs of this industry and supports its core business processes in R&D, product development, production, quality, costing, traceability and regulatory compliance. It also helps the manufacturers get rid of paperwork errors and sort their documentation, streamline the manufacturing process, reduce operating costs, speed up information distribution, and enhance product quality and process efficiency.

Key Features

• Preconfigured to manufacture soft gelatine capsules/ tablets/powders, etc.
• Raw material planning and procurement
• Supplier/vendor management and qualification
• Quality document management
• Complete support in the development of new products for contract manufacturing with enhanced features like specialized costing and quotation
• FDA 21 CFR part 11 compliance, which includes secured master data management
• Quality Control (QC) with sampling plan, stability testing
• Quality Assurance (QA) as per cGMP norms
• Formulation management: Complete formula security with audit trail, approval workflow and revision control
• Inventory management, including material characteristics such as potency, catch weight, classifications, expiration dates, lot control, and varying units of measure
• Co-product and by-product management
• Batch monitoring activities by inspection plan
• Electronic execution of SOPs by inspection checklist
• Electronic Batch Ticket and Electronic Weigh Sheet
• Manufacturing Batch Record (MBR)
• Non-conformance (NC)
• Corrective and Preventive Action (CAPA)
• Easy material substitutions
• Multiple packaging of same formulation
• Shelf life/expiration support
• Bi-directional lot traceability and lot recall
• ‘What-if’ analysis and various costing methods for increased margins
• Adverse event/complaint reporting
• Allergen management
• Mobile warehousing: Employment of handheld RF devices to execute material movement and adjustments within one or more facilities
• Integrated supply chain management
• Real-time reporting and analytics
• Dedicated module to handle all complaints, and returns
• Master Production Scheduling (MPS)
• Material Requirement Planning (MRP)

Benefits

• Enhanced quality, consistency, and speed to deliver drugs to market
• Cost control through reduced wastage
• Complete formula secrecy
• Absolute compliance to the stringent regulations
• Facilitates accurate business decisions
• Ability to respond quickly to customer demands
• Enhanced operational process flow as well as profits