Project Management

Project Management:

  • Sai Pharma Consultants provide Complete Engineering Consultancy for industries from sectors like Formulations, Bulk Drugs, Biological Products (Vaccines) & IV. It covers HVAC, Electrical, Water Systems, Steam and Piping & Insulation.
  • Provide services for audit of Utility Services, check performance v/s URS, IQ, OQ, PQ documents and report on variance.
  • Provide services for Energy Audit.
  • Provide Training of engineering personnel for PLM of Formulations & vaccines & Utilities on Systems, Operations & maintenance.
  • Provide services for preparation of validation documents.

we provide the client a brief idea about the cost effective Concept Engineering Services and the feasibility of the proposal in view of the market, production volumes, provisions for expansion, design options etc. as mentioned below:

  • Plot & Contour Planning
  • Plant Layout
  • Man & Material Movement Details
  • Preliminary Architechtural Drawings
  • HVAC Concepts
  • Preliminary Utility Specifications
  • Power Requirement Estimation
  • Preliminary Project Cost Estimation & Scheduling
  • Environmental & Safety Engineering
  • Future Expansion Possibilities
Sr No Description of deliverables
1 Basis of Design, Global assumptions for dosage forms, products, production volumes, market specific requirements, expansion schematics, automation levels, statutory requirements limiting design etc. 
2 Process Sizing
3 Process equipment sizing – Major Equipment
4 Ware-House sizing
5 Manpower sizing
Above documents will be sent to client for further discussion, internal reviews, external evaluations etc. Sai Pharma Consultants incorporates all suggested changes after due deliberations and risk analysis and then submit the final versions.
6 Process area conceptual layout 
7 Man & Material Movement marked in above layout
8 HVAC zoning marked on above layout
9 Executive summary providing all details of processes, regulatory compliance provisions, design philosophy, finishes , assumptions etc.
Above documents will be  sent to client and discussed. If required, Sai Pharma Consultants incorporates changes & submits the final version.
10 Suggestions, comments made in deliverables 6 to 9 are covered & converted in AutoCAD drawings namely Plans for each floor, sections, Man and material movement, HVAC & Pressure zoning. 
Also suggested plot plan is incorporated at this stage.
11 Submission of final concept report inclusive of Gross Utility Sizing, Plot Areas Required, Total Manpower necessary for operations, Gross Project Costing with an accuracy of +/- 20% etc. 
Qualification and Validation are integral steps in building quality into any facility. Sai Pharma Consultants have an experienced team members with an experience of over three decades, provides an efficient and effective documentation system that meets the requirements of International Regulatory authorities.

Sr No Project Planning And Management
1 Preparation of Validation documents, Validation Master Plan (VMP), Equipment Validation Plan (EVP), Risk Assessment (RA), and Impact Assessment (IA)
2 Master Validation / Qualification Schedule
Sr No Development Of Qualification Protocols – Equipments & Computer System Validation
1 Design Qualification
2 Review of User Requirement Specification (URS) considering the GMP Risk Analysis
3 Review of Functional Design Specification (FDS) of equipment for establishing traceability with URS and GMP Risk Analysis
4 Co-ordinate with vendors/Prepare Factory and Site Acceptance Testing (FAT and SAT) protocols for equipment
5 Co-ordinate with vendors/Prepare Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Protocols of the said equipment and systems
6 Preparation/ Review of Area/ Facility Qualification Protocols
7 Preparation of Product Microbial Limit Test (MLT), BET, Bio-Burden, & Sterility Method Validation Protocols
8 Preparation of Analytical Method Validation/ Verification Protocols
9 Preparation of Vendor Qualification Protocols for Raw & Packing Materials
10 Preparation of Process Validation Protocols by considering Critical Process parameters, Critical Quality Attributes as per Process Development requirements
Sr No Execution Of Qualification Process And Final Documentation At Client’s Site
1 Execute the approved IQ, OQ & PQ protocols at client’s site as per approved validation plan and guidelines
2 Compile all reports and complete the documentation in compliance with applicable International regulatory requirements
Sr No Inspection / Fat At Vendors Site
1 Conduct FAT of the systems and equipment at the vendor’s works as required
Standard Operating Procedures for Production Process, Quality Control, WAREHOUSE Engineering, Procurement Human Resource Development. Some are enlisted below:

Sr No Process
Preparation of Procedures for
1 Operation, Cleaning and Preventive Maintenance,
2 Environment Monitoring
3 Calibration of Master Instruments and Process Instruments
4 Calibration Schedules – Equipment wise
5 Operation, Cleaning, Sterilization, Disinfection, Sanitization & Monitoring
6 Gowning & De-Gowning
7 Personnel Hygiene Monitoring and control
8 Area Monitoring and control
Sr No Quality Control
Preparation & review of Procedures for
1 Instrument Qualification Protocols & Monitoring of Commissioning Activities
2 Instrument Calibration Schedule and Monitoring of Calibration Activities
3 Testing Activities of Water, Nitrogen, Raw Materials, In Process Material, Packing Material and Finished Products
4 Testing Activities of MLT/ Bio burden in Purified Water, WFI, Pure steam, Raw Materials & Product
5 Testing Activities of BET in Purified Water, WFI, Pure Steam, Raw Materials and Product Testing Activities of Product Sterility Testing
6 Media Preparation, Sterilization, Plate Preparation, Exposure Activities
7 Culture Suspension Activities & Organism Identification
8 Standard Test Procedures, General Procedures, Stability Specifications and Other Miscellaneous Test Procedures
9 Biological Indicator Qualification & Handling
10 Incubation & Inspection Activities
11 Training to Concerned Persons, Monitoring of Execution and Review of Reports
12 Disinfectants Validation Protocols, Monitoring the Execution and Review the Reports
  • Master Project Quality Plan
  • Project Quality Risk Assessment documents
  • Equipment Quality Risk Assessment documents
  • Process Quality Risk Assessment documents
  • Quality Impact Assessment documents for assessing equipment as Direct, Indirect and No Impact on Quality
  • Quality Manual & Training Manuals
  • Site Master File
  • Change Control System
  • Deviation Control System
  • Incident Control System
  • Out of Specification System
  • Market Complaints and Product Recall Handling System
  • Internal Audit / Self Inspection
  • Manufacturing Activities Monitoring System
  • Analytical Assurance & Monitoring System
  • Microbiology Assurance monitoring system
  • Engineering Assurance Monitoring System
  • Documentation System
  • CAPA System
  • Annual Product Review System
  • Management Review System
  • GLP System
  • Calibration Policy and Master Calibration Schedule
  • Development of Training Schedule for all Plant Personnel