Recent Projects by Frisby Quality Services (FQS)


 Quality Reviewer in R&D Department (Manufactures Pharmaceutical Inhalers)

  • Review of protocols, reports, validation documentation, specification, methods and batch related documentation for all stages of product development (formulation development trials, scale up trials, IND batches, optimisation trials, pilot batches, validation/process qualification batches, commercial/production batches) and  the four phases of clinical trials (Phase I – IV).

Transport ValidationConsultation for Transport Validation

  • Compilation of Quality Risk assessment for route matrix.
  • Compilation of validation master plan.
  • Compilation of protocols – reefer qualification & route qualification.
  • Auditing Transport companies and reviewing technical agreements with same.
  • Complete mapping where required.

 

Consultation on Out of specification procedure

  • Review of OOS in-line with new procedure and corporate guidelines.

 

FQS Client LogosCurrent/Previous Contracts:

 

  • Contract Qualified Person: Registered with the Irish Medicines Board to release medicinal product from pharmaceutical companies for numerous markets e.g. European, Australian and American.  Review documentation and system to ensure compliance with requirements.
  • Temperature and relative humidity mapping of warehouses and storage areas, assessing for compliance with required standards and regulations.
  • Contract Responsible Person: Registered with the Irish Medicines Board to maintain wholesale licence to store and distribute medicinal product.  Review documentation and system to ensure compliance with EU requirements.
  • Improvement projects and investigational work.
  • Implement ISO9001:2008, HACCP requirements, wholesale requirements for storage and transport industries.
  • Food Safety and HACCP Trainer: Approved trainer with the EHOA and RIPH carried out training for Enterprise Boards, FAS approved bodies and private sector.
  • Auditor for EQA Ireland Ltd.  EQA Ireland Ltd. is a certification body for many international and Irish standards.  Audit against ISO9001:2008 to ensure compliance compile report and recommend certification where compliance is met.
  • Approved mentor for Kilkenny County Enterprise Board (KCEB), mentoring for micro-enterprises in establishing food safety systems, maintaining and auditing food safety systems, establishing ISO9001:2008.

 

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