BatchMaster ERP for API
What are the Major Challenges in Active Pharmaceutical Ingredient Industry?
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.
Why API Manufacturing Businesses Require ERP Software?
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 of BatchMaster ERP for API Industry
- 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 of BatchMaster ERP in API Manufacturing
- 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.
Brochure
Happy Customers
Mr. Minsung Kim,
Head, ERP System, Dong-A Pharmaceutical
Dhawal Rajda,
IT Head, ICPA Health Products Ltd.
Mr. Ajay Tambve,
IT Head, SciTech Speciality Pvt. Ltd.
Mrs. Pallavi Kahilkar,
EDP Manager, Unijules Life Sciences Ltd.
Binoy B. Shah
Managing DirectorSee BatchMaster ERP in Action
Integrate. Extend. Excel.
Allow our expert team of solution consultants to review your business operations so that they can offer you the best-possible solution, either on premise or in the cloud, to meet all your industry-specific needs
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.Read More