Plant Designing, Commissioning & Validation
We provide services for designing & commissioning of old and new manufacturing facilities complying national and international cGMP guidelines for followings:
- Pharmaceutical Formulations/Drug Products Manufacturing Facility (Tablets, Dry Powder Sachets, Capsules, Liquid Orals, Injections & Ointment) manufacturing facilities.
- Cosmetic, Herbal &Ayurvedic Product manufacturing
- Food Products manufacturing facilities
- API manufacturing facilities (Sterile & Non-Sterile)
- Key Starting Material and Intermediate Manufacturing facilities
- Medical Devices Manufacturing facilities
- Diagnostic kit manufacturing facilities
Designing Stages Of Manufacturing Facilities
1. Conceptual Design (Feasibility Stage)
- Define project objectives, requirements, and feasibilities
- Assess market demand and production capacity
- Conduct site visit (evaluate site location, utilities & logistics)
- Identify regulatory requirements (FDA, EU-GMP, ROW/WHO & Revised Schedule M)
- Develop conceptual layouts/block flow diagrams (BFD)
- Perform cost estimation and economic feasibility analysis
- Prepare feasibility study report, concept design and preliminary cost estimate
2. Basic Design (Preliminary Design)
- Translate the concept into a more detailed and functional design.
- Develop process flow diagrams (PFDs)
- Identify process equipment & utilities requirement
- Prepare layout plans (building, manufacturing area, packing area, warehouse-RM,PM & FG area, quality control laboratory, microbiology laboratory, R&D/F&D laboratory, Analytical research laboratory pilot scale laboratory, Effluent Treatment Plant, Sewage Treatment Plant, Water treatment plant, AHU area & Utilities- Chiller placement area, Compressed air/Nitrogen system area & Boiler area etc)
- Define HVAC, water systems & cleanroom classifications
- Perform Preliminary environmental and safety assessments
- Prepare basic layouts/drawings (civil, ahu zoning, cleanrooms, personnel/material flow)
3. Detailed Design (Engineering Design)
- Finalize all technical details & drawings required for construction –
- Develop Piping and Instrumentation Diagrams (P&IDs)
- Prepare detailed equipment & utility URS & specifications
- Finalize architectural, structural, electrical, and HVAC drawings
- Design utilities systems (WFI, purified water, steam, air, etc.)
- Validate all design and data as per GMP guidelines and safety standards requirement
- Review and approve all layouts, engineering drawings and specifications
- Preparation of BOQ and tender documents
4. Construction & Installation
- Conduct site visit to monitor Civil construction of buildings and structures as per approved plan
- Conduct site visit to monitor Installation of utilities and process equipment as per P&ID and approved plan
- Conduct site visit to monitor HVAC, electrical, and control systems
- Supervision and site quality control Coordination with vendors and contractors
- Guidance for facility Installation records and documentation
5. Commissioning & Qualification
- Testing of utilities, systems, and equipment
- To coordinate and guide for DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification) &PQ (Performance Qualification) of equipment, instrument, AHU, water system and all critical utilities.
- Guidance to prepare qualification and validation reports of equipment/instrument and utilities
6. Validation
- Process validation (three consecutive successful batches)
- Cleaning and method validation
- Environmental monitoring
- Computer system validation
- Heat mapping studies
- Employee training and SOP implementation