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Copyright ® 2005 NCS Pharmaceuticals. All Rights Reserved.

NCS Pharmaceuticals' contract analytical testing laboratory is
offering cGMP, and GLP services to the pharmaceuticals,
medical devices, food, dietary supplement, cosmetics, chemical,
environmental, and allied industries. Our clients in the
pharmaceuticals industry range from suppliers of Bulk Drug
Substances to manufacturers of brand name and/or generic
Finished Drug Products. Our test procedures are based either on
the FDA, ICH ISO guidelines, USP/NF, BP, EP, JP monographs, or
on the clients' SOPs. We specialize in the chemical analysis,
dissolusion testing, and stability testing of both non-controlled
and controlled drug substances in schedules II thru V. Our
testing capabilities include: HPLC, GC/LC, Atomic Absorption
Spectroscopy, and Mass spectrometry.   

Analytical/Bio-analytical Capabilities
  •        Chromatography (TLC, GC, HPLC, GC/MS/MS,      
    LC/MS/MS, IC, GPC, DSC, Headspace Analyzer, ICP-MS,
    MALDI-ESI-QTOF)
  •        Spectroscopy (FTIR, UV/visible, Atomic Absorption,
    Inductively Coupled Plasma-Atomic Emission (ICP-AE,
    spectrofluorimetry)
  •        Analytical support for preformulation active
    pharmaceuticals drug substances and drug products
    (prescription / OTC  products)
  •        Analytical and bio-analytical method development,
    validation and method transfer in accordance with FDA
    cGMP/ICH compliances.
  •        Pre-clinical IND support for PK/TOX studies using HPLC
    and or HPlC/MS/MS methodology.
  •        Raw materials qualifications for excipients for
    pharmaceuticals.
  •        Quality rating of USP grade 0.9% NaCl injectable water
    in disposable plastic syringes.
  •        Method development, validation and transfer of
    Combination products (biological drugs/ vaccine and
    different types of medical devices).
  •        Container aqueous and volatiles
    Leachables/Extractables organic and inorganic chemical
    species.  
  •        Characterization of different types of  resin and
    industrial polymer (PEGs)
  •        Disintegration/Dissolution (including extended release)
  •      2D-Dimensional In-gel Electrophoresis
    Analysis                      
  •      Stability studies on drug substances/drug products.

ON-going R&D activities:
  •        Proteomics/biomarker discovery
  •        ELISA-based assays for anticoagulant biological drugs
    for diagnostic purposes only.
  •        Screening of small molecule library for pre-clinical
    drug discovery and development

Engineering Design, Commissioning and Validation:
NCS Pharmaceuticals has experience in engineering design,
commissioning and   validation in a wide variety of different
facilities, systems, processes and  equipment. This experience
includes, but is not limited to the following:

Facilities
  • Compounding/Formulation                                 Environmental Rooms
  • Aseptic Suites                                                        Containment Areas
  • Laboratories Controlled Substances                Medical Devices
  • Barrier Technology

Utilities/Services
  • Purified Water                                                        Process Chillers
  • Water for Injection                                                 HVAC              
  • Sterile Air                                                                Vacuum
  • Compressed Air                                                   Clean Steam
  • Plant Air                                                                   Plant Steam
  • Nitrogen                                                                  Emergency Power
  • Dust Collection                                                      Sterilize in Place
  • Waste Neutralization                                            Clean in Place

Systems/Computer Validation
  • Computer Hardware                                            Label Control
  • Computer Software                                              Automatic Inspection
  • Automated Warehouse                                       LIMS
  • Programmable Logic Controllers                    SAP                                    
  • Distributed Control Systems                              Decontamination System

Parenterals
  • Steam Sterilization                                             Environmental Monitoring
  • Depyrogenation Ovens/Tunnels                      Terminal Sterilization      
  • Aseptic Filling/Processing                                Stoppering/Crimping    
  • Stopper Washing/Sterilizing                             Lyophilizers
  • Radiation Sterilization                                        Sterile Filtration    
  • Ethylene Oxide Sterilization                              Laminar Flow Hoods
  • Form/Fill/Seal Machines                                   Inspection Stations
  • Glassware Washers/Dryers

Oral Solid Dosage Forms
  • Blenders                                                              Tablet Coaters
  • High Shear Mixers                                              Tablet Printers
  • Fluid Bed Granulators                                       Capsule Printers
  • Milling Equipment                                               Dryers
  • Check Weighers                                                 Centrifuges
  • Tablet Presses                                                   Microwave Drying

Biotechnology
  • Master Cell Banks                                            Ultrafiltration
  • Media Preparation                                            Chromatography
  • Buffer Preparation                                            Biosafety Cabinets
  • Fermentation                                                     Deactivation
  • Harvesting                                                          Neutralization
  • Separation                                                         Sterilization

Bulk Pharmaceuticals
  • Reactors                                                            Tank Farms
  • Centrifuges                                                        Solvent Recovery
  • Distillation  Columns                                       Vessels/Agitators
  • Crystallizers                                                       Filtration
  • Extruders                                                            Drying

Packaging
  • Unscramblers                                                   Neck Banders
  • Fillers                                                                  Accumulation Tables
  • Pluggers                                                            Cartoners     
  • Cappers                                                             Shrink Wrappers
  • Tamper Evident Features                               Overwrappers    
  • Labelers                                                             Case Sealers
  • Batch/Date/Bar Coders                                   Palletizers
  • Blister Packers                                                  Cottoners

PROJECTS:
  • API: We provided engineering design (estimates, vendor selections,
    specs, drawings-PFDs/P&IDs, bid evaluation, etc.), commissioning
    and validation services for active pharmaceutical ingredients (API)
    manufacturers. We managed the process validation, cleaning
    validation, and equipment/utility qualification for API manufacturers.
    Supported the clients with cleaning validation acceptance criteria and
    company-wide master plans and policies. Prepared and executed
    cleaning validation protocols and final reports. Responsible for the
    cleaning validation activities of reaction trains, centrifuges, tray
    dryers, rotary dryers, mills and blende.rs. Led a multi-discipline team
    to evaluate and improve all aspects of the cleaning validation program
    including residue limits, cleaning processes, documentation, and
    analytical methods validation. Prepared and executed equipment
    qualification (IQ/OQ) protocols and final reports for rotary vacuum
    dryers, vacuum tray dryers, stills, reactors, condensers, distillation
    columns, mills, blenders, hydrogenators, HVAC systems, BMS,
    softwall enclosures, crystallizers, and centrifuges. Prepared and
    executed process validation protocols and reports for crystallization,
    drying, milling and blending operations for API’s and their
    intermediates. Developed, Computerized Systems Master Validation
    Policy. Assessed FDA compliance status of computerized systems,
    ranging from analytical systems in the QC laboratory and SCADA,
    DCS, and HVAC systems, to databases, maintenance management,
    and QA information systems. Developed validation plans, assessment
    scripts, specifications, procedures, manuals, schedules, and
    budgetary estimates. Assembled life cycle documentation, reverse-
    engineered, and enhanced SCADA system for product dryers to
    provide compliance with 21 CFR Part 11 by implementing a SQL
    Server based audit trail, electronic signatures, and a custom batch
    reporting system. Installed dryer system upgrade, wrote test scripts,
    and cataloged changes in a report for change control closeout.
    Developed prototype for a Part 11 compliant client-server solution to
    manage training records, coordinate with legacy personnel record
    management system, and eventually automate employee and HR
    notification of training requirements via e-mail. Prepared SOPs for
    cleaning validation, process validation, equipment qualification,
    master planning, and computer validation.

  • Solid Dosage: Provided engineering design, commissioning and
    validation services for solid dosage facilities. Generated/executed
    protocols and final reports for Quadro Comil, Stokes Granulator, AMF
    Mixer, PK Blenders, Ribbon Blender, Stokes Vacuum Dryer, Williams
    Tablet Conveyer, H&K Encapsulator, Mocon Vericaps, Pro-Quip
    Inspection Belt, Key Capsule Polisher, Metal Detector, Stokes Sugar
    Coating Pan, Coating Solution Tank, and PIAB Pneumatic Tablet
    Transfer System.

  • Mammalian Production: Provided detailed design for cell culture pilot
    plant. Involved with start-up and commissioning, and validation of
    automated centrifuge with CIP/SIP, clean gas systems, plant control
    system, plant/clean steam, USP Purified Water, WFI, cooling tower
    water, and plant/process chillers. Prepared validation turnover
    packages, generated/executed validation protocols and reports for
    cooling tower water, reverse osmosis water, WFI, USP Purified Water,
    HVAC clean gases, plant control systems, ultrafiltration skids, depth
    filter housings, CIP skids, B. Braun bioreactors, buffer tanks, media
    tanks, chromatography skids, column packing, autoclave, glass
    washer, centrifuges, pumps, filters, cold rooms, freezers,
    refrigerators, and incubators.

  • Clinical Production: Provided services to the clinical manufacturing
    facilities. Directly involved with start-up and commissioning of
    process control system, HVAC, UPS, clean compressed air,
    plant/clean steam, USP Purified Water, plant/process chillers, process
    tanks, incubators, shakers, fume hoods, biosafety hoods, laminar flow
    hoods, and bio-waste system. Prepared validation turnover packages,
    generated/executed validation protocols and reports for process
    control system, HVAC, clean compressed air, clean steam, USP
    Purified Water, incubators, and process tanks.

  • Cell Culture: Provided services in design, commissioning and
    validation for the bioreactors projects. Prepared validation master
    plan for project. Prepared and executed equipment qualification
    (IQ/OQ) protocols.

  • Contract Packaging and  Contract Manufacturer: Developed cleaning
    validation and packaging validation programs including preparation of
    the validation master plans, preparation of SOPs, and development of
    the validation protocols. Did audit including the areas of cleaning
    validation, process and packaging validation, process equipment,
    HVAC, filling machines, control systems, and utility systems, and
    laboratory systems qualification. Provided design, start-up,
    commissioning and validation for contract research organization and
    contract manufacturers. Supported the installation of packaging
    equipment for the manufacture of an insulin metering system.
    Performed start-up, commissioning, and validation (IQ/OQ) activities
    for EAM Fillter/Capper, Chromatography Systems, EAM Cartridge
    Assembly Machine, Comas Plunger/Insert Assembly Machine, Cazzoli
    Gross Washer with Siliconization, Cazzoli Stopper Washer, Receiving
    Vessels, and Formulation Vessels, Lab Equipments, etc. Developed
    and executed depyrogenation protocols. Prepared SOPs.       
Copyright ® 2007 NCS Pharmaceuticals. All Rights Reserved.