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
Stability 
- 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
