design & consulting

    Qualification and Validation are integral steps in building quality into any facility. Spectrum with an experience of over two decades provides an efficient and effective documentation system that meets the requirements of International Regulatory authorities.

    Spectrum with its team of experts can manage development and implementation of entire Validation program for its Customers.

    1. Project Planning and Management

      • Preparation of Validation documents, Validation Master Plan (VMP), Equipment Validation Plan (EVP), Risk Assessment (RA), and Impact Assessment (IA)
      • Master Validation / Qualification Schedule
    2. Development of Qualification Protocols – Equipments & Computer System Validation

      • Design Qualification
        • Review of User Requirement Specification (URS) considering the GMP Risk Analysis
        • Review of Functional Design Specification (FDS) of equipment for establishing traceability with URS and GMP Risk Analysis
        • Prepare Design Qualification protocol and establish qualification for each equipment
      • Co-ordinate with vendors/Prepare Factory and Site Acceptance Testing (FAT and SAT) protocols for equipment
      • Co-ordinate with vendors/Prepare Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Protocols of the said equipment and systems
      • Preparation/ Review of Area/ Facility Qualification Protocols
      • Preparation of Qualification Protocols (SRS, RA, PVP, ERES, HLRA, IQ, OQ, PQ) for PLC, HMI, SCADA, Camera System in Compliances with GAMP 5 and 21 CFR Part 11
      • Preparation of Product Microbial Limit Test (MLT), BET, Bio-Burden, & Sterility Method Validation Protocols
      • Preparation of Analytical Method Validation/ Verification Protocols
      • Preparation of Vendor Qualification Protocols for Raw & Packing Materials
      • Preparation of Process Validation Protocols by considering Critical Process parameters, Critical Quality Attributes as per Process Development requirements
    3. Execution of qualification Process and Final Documentation at client’s site

      • Execute the approved IQ, OQ & PQ protocols at client’s site as per approved validation plan and guidelines
      • Compile all reports and complete the documentation in compliance with applicable International regulatory requirements
    4. Inspection / FAT at Vendors site

      • Conduct FAT of the systems and equipment at the vendor’s works as required
  2. Standard Operating procedures

    • Process

      • Preparation of Procedures for Operation, Cleaning and Preventive Maintenance
      • Preparation of Procedures for Environment Monitoring
      • Preparation of Procedures for Calibration of Master Instruments and Process Instruments
      • Preparation of Calibration Schedules – Equipment wise
      • Preparation of procedures for Operation, Cleaning, Sterilization, Disinfection, Sanitization & Monitoring
      • Preparation of procedures for Gowning & De-Gowning
      • Preparation of procedures for Personnel Hygiene Monitoring and control
      • Preparation of procedures for Area Monitoring and control
    • Quality Control

      • Review of Instrument Qualification Protocols & Monitoring of Commissioning Activities
      • Preparation of Instrument Calibration Schedule and Monitoring of Calibration Activities
      • Preparation of Procedures for Testing Activities of Water, Nitrogen, Raw Materials, In Process Material, Packing Material and Finished Products
      • Preparation of Procedures for Testing Activities of MLT/ Bio burden in Purified Water, WFI, Pure steam, Raw Materials & Product
      • Preparation of Procedures for Testing Activities of BET in Purified Water, WFI, Pure Steam, Raw Materials and Product
      • Preparation of Procedures for Testing Activities of Product Sterility Testing
      • Preparation of Procedures of Media Preparation, Sterilization, Plate Preparation, Exposure Activities
      • Preparation of Procedures of Culture Suspension Activities & Organism Identification
      • Preparation of Standard Test Procedures, General Procedures, Stability Specifications and Other Miscellaneous Test Procedures
      • Preparation of Procedures of Biological Indicator Qualification & Handling
      • Preparation of Procedures of Incubation & Inspection Activities
      • Training to Concerned Persons, Monitoring of Execution and Review of Reports
      • Preparation and Develop the Disinfectants Validation Protocols, Monitoring the Execution and Review the Reports
    • Warehouse

      • Preparation of Procedures for Goods Receiving, Storage, Segregation, Sampling, Dispensing and Issuance
      • Preparation of Procedures for Monitoring /recording of Storage condition
      • Preparation of Procedures for storage of Finished Goods

    • 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


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