The Pharmaceutical and Medical Device industries rely on a fragmented and complex supply chain to get product in to market. Your organisation or your suppliers could be conducting a single step or multiple steps of manufacture, and as such must adhere to the principles of GMP that apply to your operation and the market in which your product is being sold.
SeerPharma routinely conducts GxP inspections of organisations throughout the Asia-Pacific region, conducting nearly 100 inspections a year. In the last 12 months, we have seen our team conduct both on-site and virtual/remote inspections of organisations in countries such as China, India, Singapore, Australia, Japan, New Zealand and Indonesia.
The requests for our auditing services typically fall in to five (5) categories:
- Due Diligence Inspection – where SeerPharma is asked to assess the suitability of a supplier or suppliers to conduct a step(s) of manufacture as part of a merger/acquisition OR expansion of a company’s supplier network.
- Initial Inspection – where SeerPharma is asked to conduct the initial audit of a supplier that has been selected to conduct a step(s) of manufacture.
- Routine Inspection – where SeerPharma is asked to conduct routine inspections as part of a Supplier QA program.
- Regulatory Mock Inspection – where SeerPharma is asked to assess operations as an inspector, typically in preparation for an impending notified body inspection, or regulatory audit from bodies such as the US FDA, TGA, MHRA or HSA.
- Internal Audit – where SeerPharma is asked to assist with internal audits to help alleviate the pressure of maintaining an internal audit program.
Inspections in categories 1 to 4 can range from 1 day to 5 days with typically one or two consultants on site. A detailed report with findings observed leaning on our extensive experience will be provided within 10 working days.
For Internal Audits, SeerPharma will work within a company’s Quality Management framework to conduct audits within the expected timeframe and reporting requirements.
Click here for more information on our Auditing services.
Or Contact us if you have an immediate or impending need for GxP audit in the Asia-Pacific region.