Good Manufacturing Practice
Regulatory authorities like the Therapeutic Goods Administration (TGA), Medsafe, the various European authorities and the US FDA require manufacturers of medicines and medical devices to comply with strict standards on Good Manufacturing Practice (GMP).
Our team includes a recognised expert in GMP with a lifetime of career experience auditing local and overseas manufacturers for the TGA. So we know what it takes to get the GMP tick.
If You’re a Manufacturer
We can help you ensure your people, manufacturing facilities and processes are safely within the relevant Codes of GMP.
We can inspect your facility (either local or overseas) before an audit, to give you a ’dress rehearsal’ of what is to come and to identify any major issues. We can also be on-site during the the regulatory authority’s inspection to help you to respond to the auditors’ questions ‘on the spot’.
We will also help you respond quickly and effectively to any deficiencies identified in the official auditor’s report.
If You’re a Sponsor
We can help ensure that your technical contracts include all of the provisions that are required under the ‘PIC/S Guide to Good Manufacturing Practice for Medicinal Products’.
For Australian sponsors, you will need to get a TGA clearance for any of your manufacturers that are located overseas. We can tell you whether a TGA inspection will be needed, if you will need to provide data for desk audit, or if a simple clearance is all that will be needed. We can prepare the necessary applications for you, or help you to do it yourself.