BatchMaster ERP for Active Pharmaceutical Ingredient (API)

Challenges to Overcome

Adhering to strict safety and quality standards, set by both the country of production as well as end-consumption, controlling costs, addressing increasing pressure to reduce waste and manage the by-products efficiently, facing intense competition in the highly-fragmented market along with patent expiry of branded products, etc. are some of the major issues API manufacturers deal with.

Solution

BatchMaster ERP for API is designed to streamline all stages of API manufacturing be it chemical or bio-synthesis right from starting material, intermediates, their isolation & purification, to physical processing and packaging along with ensuring physical processing & packaging, purification and safe disposal of impurities to ensure efficient by-product management. Supporting all business models be it- own manufacturing contract manufacturing, loan-licensing or mixed, BatchMaster ERP ensures compliance with industry-specific regulations of labeling, bi-directional lot traceability, FDA 21 CFR part 11, and adverse event reporting.

Key Features

Ideal for all business models- contract manufacturing, own manufacturing, loan licensing, etc.
Segregation and traceability of inventory based on different customer
Raw material planning and procurement
Supplier / vendor management and qualification
Production support right from starting material, intermediates, their isolation & purification, to physical processing and packaging
FDA 21 CFR part 11 compliance
Quality Control (QC) with sampling plan, stability testing
Define QC tests per cGMP norms like quarantine, release and reject
Inventory management: Classification of inventory as starting materials, by-products, intermediates, reagents, ligands, catalyst, impurities, etc
Formulation: Complete formula security with audit trail and approval workflow
Batch monitoring activities by inspection plan
Electronic execution of SOP’s by inspection checklist
Dedicated module to handle all complaints, returns and recalls

Safe handling of materials with SDS for safety of employees and transportation
Electronic Batch Ticket, Electronic Weigh Sheet and Manufacturing Batch Record (MBR)
Corrective and Preventive Action (CAPA) & Non-conformance (NC)
Easy material substitutions
Multiple packaging of same formulation
Shelf life / expiration support
Bi-directional lot traceability and lot recall
Separate granular costing of formula and packaging material
'What-if' analysis and various costing methods for increased margins
API contract manufacturing support
Adverse event / complaint reporting
Allergen management
Mobile warehousing: Employment of handheld RF devices to execute material movement and adjustments within one or more facilities
Dedicated module to handle all complaints, returns and recalls
Master Production Scheduling (MPS)
Material Requirement Planning (MRP)

Benefits

Enhance the quality, consistency, and speed to deliver drugs to market
Control costs through reduced wastage
Helps to take accurate business decisions

Ensure absolute compliance to the stringent regulations
Maintains your formula secrecy

Respond quickly to customer demands
Smoothens operational process flow and enhance profits

Cloud Deployment Available

Give your small, mid-size, or large-scale businesses the power of our ‘Cloud ERP’ solutions, and enjoy the benefits of leveraging the cloud.

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Resources

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BatchMaster ERP for API

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About Us

BatchMaster Software is one of the market leaders in offering enterprise software solutions for the process manufacturing industries. With an in-depth industry analysis, gained through a vast industry experience with over 2000 implementations worldwide, we clearly understand the unique industry challenges. BatchMaster offers ERP solutions that are apt to support industry specific operations and handles critical processes of the micro-verticals. Process manufacturing companies around the globe have come to rely upon BatchMaster® to manage nearly every aspect of their manufacturing distribution, finance & accounting, Quality Control, Compliance and HR- related operations. With headquarter in Laguna Hills, BatchMaster has its offices in New Jersey, India and New Zealand.
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