Having several years of Analytical Management experience with FDA and EU GMP Laboratories, Timoney Quality Consultants are the preferred partner to take care of all your Analytical issues ( Microbiological and Analytical Chemistry testing) .  The range of services available include;

  • Set up of a GMP Compliant Laboratory system to satisfy FDA /IMB and ISO 17025 requirements including trending of OOS /OOT results and Laboratory deviations
  • Equipment  selection  and subsequent qualifications  including DQ,URS,IQ,OQ,PQ , Calibration and Preventative Maintenance
  • Process qualifications including cleaning validation, steam sterilization and dehydrogenation validations
  • Test method validations as per Regulatory requirements
  • Method transfer  and Compendial method verification as per GMP
  • Introduction of a range of analytical techniques associated with HPLC,GC , Dissolution, TOC, Particle size, FTIR  technologies etc
  • Introduction of a range of Microbiological tests including endotoxin ( gel clot and kinetic), Preservative Efficacy testing ,Media growth promotion testing ,Microbial limit testing  and absence of specific Pathogens  etc
  • Trouble shooting a range of  Analytical methods
  • Validation of Laboratory software systems as per GAMP and CFR 211 Part 11 e.g. Empower, LIMS etc


  • Preparation of stability protocol in compliance with ICH Guidelines Q1A(R2) and Q1B including matrix approach ,sample plans ,climates Zones ,thermal/thermo cycling
    • Selection of appropriate testing and specifications in accordance with ICH Q6A,Q6B and Q3A
    • Validation /verification of  stability indicating test methods using forced degradation /photostability pathways
    • Investigation of out of specification stability test results and out of trend .atypical results .

Completion of corresponding stability report with particular focus on out of specification test results reported during program and recommendations for expiry dating within the market