Laboratory Services

Laboratory Services
Product Description

Laboratory Services
We are your partner for pharmaceutical analysis and quality control. With 25 years’ experience and continuously striving for improvement, we deliver our analytical services for drug substances, drug products, medical devices and drug-device combination products at a high quality level. Alongside the development and validation of analytical methods, batch release testing, stability testing and structure elucidation, the risk-based and solution-oriented consultation of our clients according to current regulatory requirements is one of our core competencies.

With our long-term experience in trace analysis we offer the complete management and laboratory services for extractables & leachables studies, cleaning validation studies and the investigation of genotoxic as well as elemental impurities. We support you with troubleshooting in production issues and offer you express services in root cause analysis using modern screening methods for objectionable organic and inorganic impurities as well as particles.
More than 40 employees in our analytical laboratories implement our clients’ requirements, target-oriented and efficiently, supported by lean management tools. With interdisciplinary teams and professional project management, we ensure your complex projects are successful. Our laboratories are GMP-certified and we have a manufacturing license for the release of clinical batches  and market batches.

Quality Control of Drug Substancesand Drug Products

  • Method development and validation
  • Batch release
  • Stability studies
  • Impurities from API synthesis and degradation products
Trace Analysis
  • Extractables & leachables:investigation of packaging materials
  • Potentially genotoxic impurities 
  • Troubleshooting in production issues 
  • Residual solvents

Quality Control of Medical Devices
Consulting on CMC-related Topics

HWI pharma services GmbH

  • DE
  • 2015
    On CPhI since
  • 2
    Certificates
  • 100 - 249
    Employees
Consultancy
Contract Service
Manufacturer/Innovator

HWI pharma services GmbH

  • DE
  • 2015
    On CPhI since
  • 2
    Certificates
  • 100 - 249
    Employees
Consultancy
Contract Service
Manufacturer/Innovator

More Products from HWI pharma services GmbH

  • Method Development/ Validation

    Product Method Development/ Validation

    Laboratory Services & Quality Control
    Our services in summary:
    • Analytical method development and validation
    • Quality control services for drug substances, drug products and medical devices
    • Structure elucidation
    • Trace analysis: extractables & leachables studies, genotoxic impurities, cleaning validation studies, elemental impurities
    • Consulting on CMC-related topics 
    • Root cause analysis of contaminations in production issues 
    Laboratory Services
    Quality Control of Drug Substances and Drug Products

    Method development and validation
    We develop and validate analytical methods for identity testing, assay, related substances and in vitro dissolution testing for drug substances, excipients, intermediates and finished drug products, according to international guidelines and GMP requirements. For that purpose, we implement state-of-the-art analytical methods and chromatographic separation techniques (HPLC, GC) using various  detectors such as UV/DAD detection, fluorescence detection, refractive index detection, evaporative light scattering detection, conductivity detection, flame ionisation detection and mass selective detection. Validation protocols and reports can be issued in German, English or French and can be directly incorporated into marketing authorisation dossiers.

    Batch release
    We have a manufacturing authorisation according to the German Drug Law (AMG) § 13 (1), for the batch release of drug substances and drug products as well as clinical batches. We conduct analytical testing for the EU release of drug products.

    Stability studies

    Impurities from API synthesis and degradation products

    • Development and validation of chromatographic testing procedures for purity testing of drug substances and drug products as well as medical devices and drug-device combination products
    • Development of stability indicating methods including stress testing according to ICH Q3A & Q3B
    • Identification of impurities and related substances using mass spectrometry (GC-MS/LC-HRMS) and NMR
    • Isolation of impurities using (semi-)preparative LC
    • Qualification and distribution of purity reference standards
    • Consulting for setting up specifications & toxicological evaluation of impurities

    Trace Analysis
    • Extractables & leachables:
    • investigation of packaging materials
    • Potentially genotoxic impurities
    • Troubleshooting in production issues
    • Residual solvents
    • Quality Control of Medical Devices

    Consulting on CMC-related Topics


  • Impurities

    Product Impurities

    Impurities from API synthesis and degradation products
    • Development and validation of chromatographic testing procedures for purity testing of drug substances and drug products as well as medical devices and drug-device combination products
    • Development of stability indicating methods including stress testing according to ICH Q3A & Q3B
    • Identification of impurities and related substances using mass spectrometry (GC-MS/LC-HRMS) and NMR
    • Isolation of impurities using (semi-)preparative LC
    • Qualification and distribution of purity reference standards
    • Consulting for setting up specifications & toxicological evaluation of impurities
    Trace AnalysisExtractables & leachables:
    investigation of packaging materials
    • Individual set-up of extractable studies based on packaging material and product composition
    • Identification of extractables using in-house LC-HRMS and GC-MS methods
    • Toxicological evaluation of extractables and potential leachables
    • Development and validation of leachables method based on results of extractable studies
    • Migration studies within stability testing for investigation of leachables
    Potentially genotoxic impurities
    • Development of control strategies according to ICH M7
    • Review of synthesis pathways
    • Trace analysis and ultra-trace analysis including analytical method development and validation forpotentially genotoxic impurities (PGIs)
    • Setting up specifications according to TTC approach
    Troubleshooting in production issuesExpress services for investigation of production issues including root cause analysis
    • Structure elucidation of organic impurities using in-house screening methods with LC-HRMS, GC-MS and LC-SPE / NMR
    • Investigation of inorganic impurities using SEM-EDX and ICP-OES/MS techniques
    • Determination of particles using X-ray micro/nanotomography, SEM-EDX and RAMAN microscopy /chemical imaging   
    • Particle size distribution using Malvern Mastersizer ® & Helos ®   
    Residual solvents    

    • Product-specific validation for residual solvents according to Ph. Eur. 2.4.24 and ICH Q3C
    • In-house method for high-price samples using very low sample amounts   
    • Identification of unknown residual solvents using GC-MS and NIST database

HWI pharma services GmbH resources

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