Validation

In relation to validation ,Timoney Quality Consultants  can :

  • Prepare the relevant documents in compliance with the required Regulatory requirements
  • Execute the required validations in compliance with the preapproved protocol or provide training /mentoring to the client to support their internal execution
  • Prepare a supporting report including discussions relating to out of specification results/deviations and /orapprove subsequent validation reports on behalf of the client.
  • Propose appropriate specifications for routine process control
  • Identify areas for Continuous improvement /cost reduction projects using various lean /6 sigma tools
  • Review your current validation data and files versus current Regulatory requirements and provide a gap analysis report detailing action items to be completed and guidance on how to complete these action items.

Timoney Quality Consultants offer the following validation services :

  • Preparation of Validation  documents   ( URS/ MVP/FMEA/OQ/PQ) in relation to  the range of manufacturing processes applicable to API and Solid dosage manufacture (tablets/capsules / creams/ ointments ), liquids ( sterile and nonsterile), Biopharmaceuticals  and Medical Devices including  combination products.
  • Cleaning validation including detergent effectiveness and residual levels.
  • Product sterilizations including Filter ,Steam, Ethylene oxide, Gamma and E beam
  • Preparation of annual product reviews as  per GMP

Regarding  Facility validation, we can assist with :

  • Cleanroom validation and subsequent environmental monitoring  in conjunction with appropriate action and alert limits.
  • Water  systems validations ( purified ,water for injection and steam) and subsequent routine monitoringprograms.
  • Qualification of  gas lines – compressed air ,nitrogen etc
  • Equipment qualifications  including URS /IQ/OQ  and Software qualification ( GAMP and CFR 11 compliant), Calibration and subsequent procedures for Operation ,calibration ,cleaning and Preventative maintenance
  • Test method validation including both  Analytical chemistry and Microbiology in compliance with the relevant Regulatory  and Compendial requirements.