An Australian pharmaceutical company engaged SeerPharma to prepare them for a TGA and FDA GMP inspection. Their Engineers were relatively inexperienced in dealing with regulatory inspections and the company required them to gain experience quickly in preparation for the FDA’s arrival. SeerPharma were requested to perform a mock audit to help meet this objective and focused on 5 key areas that involved different groups of Engineers.
SeerPharma audited the following facilities and services:
- Water System
- HVAC
- Filling Lines
- Autoclave
- Warehouse/Sampling Room
The mock audit was conducted against FDA CFR 211 and various Guidelines on Aseptic processing; Quality Systems Approach to Pharmaceutical cGMP Regulations; Process Validation; CPGM – Pre-Approval Inspections; Container Closure Integrity; ISO14644 and USP.
With over 35 years in industry, SeerPharma specialise in TGA and FDA compliance. SeerPharma has conducted many GMP upgrade programs across Asia Pacific, project managing validation and licensing of GMP facilities.
Contact us should you require assistance with preparing for an impending inspection from a local or international regulator.
This post comes from our July 2015 Journal.
