Timoney Quality Consultants are trained  GMP lead auditors ( FDA ,IMB,ISO ) and have extensive experiences in both Pharmaceutical (including  API ,solid dosage ,steriles and Biopharmaceuticals ) and Medical Devices including Combination products.

As part of the Audit service provided we can :

  • Introduce your internal audit program – SOP and audit schedule in compliance with GMP,FDA , ISO 13465 etc
  • Introduce your Supplier audit program – SOP and Vendor audit schedule in compliance with GMP,FDA and ISO 13465.
  • Provide certified  Internal auditing training ( tailored to suit your facility) to your team to enable them execute audits in compliance with GMP,FDA and ISO 13465

We can provide the following auditing services:

  • Initial qualification audits to approve new supplier and subsequent routine audits to satisfy your Vendor management requirements.
  • API Suppliers as per ICH Q7A and EU GMP Vol 4
  • Third party manufactures ( tablets /capsules /liquids including sterile products ) in compliance with GMP,cGMP- Medical device Manufacturers including combination products in compliance with ISO 13465 and CFR 820
  • OEM Suppliers in accordance with ISO 13465 and CRF 820
  • Sterilization subcontractors :  ( Ethlyene Oxide, Gamma and  E Beam )
  • Contract Laboratories – Microbiology and Analytical Chemistry
  • Warehouses in compliance with GDP
  • Computer software validation in compliance with GAMP and CFR Part 11
  • Due Diligence audits
  • Mock audits in preparation for Regulatory inspections –IMB ,FDA and various Notified Bodies – NSAI,TUV,BSI,TGA etc
  • Responding directly to non conformances arising during Regulatory Inspections or client audits .

We work closely with the  auditee team to ensure all non conformances are appropriately addressed