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   HWI group - innovative technologies and services for API and
medicinal products

rubric : service provider
 

HWI group provides at 3 sites in Germany a wide range of inividual and specialised pharmceutical services for pharma & biotech,
especially for active ingrdients and medicinal products.

Benefit from our long-​standing experience in laboratory services, pharmacovigilance and QP services, API assessment as well as drug development.
In regulat0ry affairs services we work together with an external partner.


Content
Technologies
Laboratory and Consultancy Services
Group Profile

Technologies  


 

  • Service provider
  • Laboratory Services

    • • Method development and validation
      • Purity testing of particular impurities – trace analysis
      • Structure elucidation
      • Trouble shooting (root cause analysis)
      • Extractables & Leachables testing
      • Batch release and stability testing
      • Reference standards for quality control
  • Pharmacovigilance & QP Services

      • Pharmacovigilance

      • GMP & GDP, GVP services / advice

      • Establishment of quality management and                         pharmacovigilance systems

      • Batch release(6 QPs), GMP audits

 

  • Life Cycle Management


  • API characterization


  • Drug Development / innovative formulation (parenteral, nasal, solid, semi-solid)
  • small batches und clinical trial batches
    (incl. serialisation, labeling, packaging)


Laboratory Services - Pharmacovigilance & QP services - Drug Development Services / innovative formulation

 
Laboratory Services Pharmacovigilance & QP services Drug Development Services / innovative formulation

Laboratory Services   
Quality control for drug substances, intermediates, excipients & drug products as well as medical devices and drug-device combination products

development & validation routine Testing purity Testing – trace Analysis consulting covering all topics in the CMC field Reference Standards assay standards Ident- and purity standards
• chromatographic   methods

• titration testing   procedures

• for assay, purity   and drug release
• batch release         testing /      quality control

• stability   studies   and stability   storage   facilities   (25⁰C/60%,     30⁰C/65%,     30⁰C/75%,   40⁰C/75%,    2-8⁰C)

• photostability    studies

• extractables /
  leachables studies

• potentially   genotoxic impurities    (PGI)

• cleaning             validation studies

• cleaning validation   studies

• elemental impurities    (EI)

• residual solvents          (RS)

• troubleshooting &    root cause
   analysis :              impurities
   from production    processes

• structure               elucidation using       mass spectroscopy    and NMR

• modern analytical        physica methods,   SEM-EDX,   Raman, XMT

• comprehensive risk   based evaluation of   product quality   regarding analytical    questions

• review of   specifications,   analytical                  procedures,   validation reports   according to   
  up-to- date scientific   knowledge                  and regulatory   requirements

• gap analysis of    module 2.3/3   together with our   regulatory, drug   development and   production experts

isolatopn and              qualification of              pharmaceutical             reference standards    in accordance with    all legal and                  regularity
   requirements
   in the GMP         environment

 

 

qualification of   pharmaceutical   reference standards   including dossier   preparation for   submission in              3.2.P.5.6
  



rimary        reference   standards   (complete        documentation)

working             standards
  (batch-related     CoA)
 

Pharmacovigilance & QP services

pharmakovigilance quality management batch release for medicinal products

Adoption of responsibility as
  EU-QPPV and graduated plan officer   (“Stufenplanbeauftragter”)
  by our own staff

Case processing, periodic reports and   risk management plans

Signal management

Review and gap-analysis of your   pharmacovigilance system

compilation and maintenance of the   pharmacovigilance system master file   (PSMF)

comprehensive advice and support
  in meeting requirements of quality   management according to the German   Drug Law (AMG),  Ordinance on the   Manufacture of Medicinal Products and    Active  Substances (AMWHV) and
  EU- GMP guidelines

• implementation, management and   maintenance of a quality assurance   system (incl. pharmacovigilance system)

application for manufacturing,
  import and wholesale authorisations

planning and performance of GMP, GDP-      and GVP-audits and self-inspections

batch release by a Qualified Person from   HWI or as external Qualified   Person

Drug Development Services / Innovative formulation


API characterization

GMP and non-GMP development and manufacturing of :

            solid dosage forms: tablets, coated tablets, mini tablets, dragees, hard capsules, granules, pellets, powder

            semi-​solid dosage forms: creams, gels, emulsions

            • liquid dosage forms: solutions, nano- and micro suspensions, lyophilisat

            • parenteral dosage forms

            • dosage forms with modified active-​ingredient release

handling of toxic and high potent APIs up to OEB 5

manufacturing of small and clinical trial batches

trouble shooting (drug substance and drug product)

Primary- and secondary packaging inclusive labelling and serialisation

 




Group Profile

 

HWI pharma services, headquarters Ruelzheim
offers services for the pharma & biotech industries. Our Ruelzheim site has more than 30 years of experience in the development and validation of analytical methods, trace analysis, troubleshooting, quality control and stability testing of active substances, excipients and medicinal products, as well as drug-related products and medical devices. We are GMP- and FDA-certified and hold a manufacturing licence for the release of clinical and market batches. Our reference standard concept extends from a wide range of qualified primary and working standards to complete just-in-time supplies for quality control laboratories

GVP copmpliance
We have our own GVP-compliant pharmacovigilance system and offer extensive support regarding the safety of medicinal products. Our competent team advices on how to fulfil quality-management requirements in accordance with legislation.

Frankfurt site
Our Frankfurt site specialises in the development of highly innovative medicinal products with potent active substances up to OEB class 5 for oral and parenteral administration to patients in a wide range of indications.

Appenweier site
Our Appenweier site is specialised in the development of solid and semi-solid formulations and to manufacture clinical trial samples and small scale batches including the whole logistic.





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