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FusionXpert Solutions

“Quality is the Best Business Plan”

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Services

Our Services

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Pharmaceutical Quality Management Systems

  • Quality Assurance Procedures
  • Standard Operating Procedures
  • Quality Risk Management
  • Validations & Qualifications
  • Specifications & Standard Testing Procedures
  • Site Master File
  • Validation Master Plan
  • Quality Manuals
  • Safety Manuals etc.

Licensing with Regulators

  • Drug & Cosmetics Approvals
  • Ayush Manufacturing Licenses
  • Factory and Labour License
  • Pollution Control Board / EPR
  • Fire NOC
  • NABL/ NABH/ EPA/ CE
  • Legal Metrology
  • FSSAI
  • Brand /Trade Mark Registration
  • BIS Certifications
  • ESI/ PF Registrations
  • Wholesale & Retail Drug License
  • ISO Certifications
  • SEDEX Certifications
  • Company Registrations
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Technical Support for Turnkey Projects

  • Plant Layout as per Revised Schedule M of Drugs and Cosmetic Act & COS Regulations.
  • Quality Control Lab Set up as per GLP.
  • Microbiology Lab set up as per GLP.
  • Utilities Installation and Qualifications which includes Air Handling Units, Purified Water Systems, Air Compressor, Boilers, etc.
  • Equipment & Instruments Installation and qualification.
  • Complete set of documents which includes, manufacturing license, Qualifications, Standard Operating Procedures, Validations etc.

Operational Excellence Program

  • Implementation of Kaizen, POKA YOKE, 5S
  • Cost of Poor Quality.
  • Overall Equipment Effectiveness
  • Internal & External Failures
  • Cost per Unit
  • Yield Improvements
  • Planned v/s Actual
  • Failure Mode Effect Analysis & Control Charts
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Audit Management & Quality Inspections

  • Vendor GMP & QMS Audits
  • Plant audits as per Revised Schedule M of Drugs and Cosmetics Act and Cos Regulations.
  • Quality Management System audits.
  • Onsite Product Quality Inspections.
  • Clients / customer audits as per the customer requirements.