Our commissioning and qualification team has the technical skills and experience of Pharmaceutical Machines and Equipment to make our clients' projects successful. We apply industry knowledge to understand the risk, identify and solve the bottlenecks and ensure that execution of the project is seamless and in accordance with GMP guidelines. We, as expert GMP consultants, ensure that we follow international and local regulations in projects we execute.
The audit and quality management system in place shall rectify problems before they become big and thus create an environment where fast correction leads to right methodology of execution, commissioning and validating the Pharmaceutical facility thus completing a crucial link in Turnkey Pharmaceutical Engineering.
Our team is equipped with various international guidelines for installation and commissioning of Pharmaceutical facilities. The various stages of installation and commissioning are:
- Installation Plan with defined sequence of activities of installation
- Preparation of the specification measurement document
- Mobilization of expert staff
- Daily installation progress, feedback mechanism and course correction techniques
- Field Report generation
- Phased wise commissioning line-up
- Data recording and commissioning set-up
- Monitoring and testing
- Validation
We will provide the following Qualifications based on the client requirement .
· Qualification Protocols Writing and Execution
· Installation, Operational and Performance Qualification
· Validation Master Plan
· Commissioning Plan
· Cleaning Validation
· Process Validation
· Media Fill Protocols
· Calibration services
· Witnessing of Supplier Testing Activities (FAT/SAT support)
· Inventory and Qualification of Process Equipments and Utilities
· Quality Risk Management
· User Requirement Specifications
· Clean Room Qualification
· Temperature Mapping Services
· Transport Validation
We will provide the following facility Qualification support based on client request.
· Concept Development for Manufacturing Facilities and Laboratories
· Support for Basic & Detail Design Support
· Technology Transfer Support
· Commissioning Support
· GMP Review
· Design Qualification
· Construction Supervision
· Project Management
· Visual Factory Programs
· Risk-Based Process Equipment & Utilities Maintenance Plans
· Value Stream Mapping
· Overall Equipment Efficiency (OEE)
· Cost-Effectiveness optimization with Operational Excellence Programs
· Lean-Production programs
· Procurement Support
· Complete Facility Qualification And Validation
COMPLIANCE AND COMPUTER SYSTEM VALIDATION
- Compliance and Computer system validation We partner our clients, working with them to define the road to compliance within their environment. We have the knowledge and experience to help the customer assess and define their compliance and validation requirements. We have the team of talented and committed people to provide excellent services.
- Comprehensive GAP & Risk Analysis.
- Most appropriate & latest GAMP, 21CFR Part 11, EU Annex 11 guideline based compliance services for your new/ legacy system
- Validate Laboratory Equipment software, IT system, Network validation as per GAMP
- Validate Building Management & Environment control system
- Validate Database systems including ERP such as SAP & LIMS
- Validation health checkup & existing customers
The activity begins with providing Validation Master Plan and thereby supporting our customers to the very end of total validation of the facilities.
