Manufacturing Medicines and GMP

All medicines manufacturers must hold either a TGA licence (Australian manufacturers) or, for overseas manufacturers, an equivalent overseas certification that is acceptable to the TGA and covers the scope of the products to be entered in the ARTG.  This includes all manufacturers involved in making, packaging, testing and releasing the finished product and it applies to all categories of medicine supplied in Australia and New Zealand. 

If an overseas manufacturer does not hold acceptable overseas certification, a TGA certificate will be needed.

In addition, sponsors and manufacturers often conduct audits of manufacturing and related facilities to satisfy themselves that the facilities are compliant with the relevant requirements, or to determine whether they are capable of passing a regulatory inspection by the TGA.

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’.

At Archer Emery & Associates, we can help you by:

• Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed GMP medicines manufacturing licences/certifications
• Reviewing systems and documentation to determine whether the relevant requirements are met
• Conducting mock audits either in person or virtually (online) and providing reports of outcomes
• Preparing GMP licence/certification applications and associated supporting documentation as needed and submit to the TGA
• Liaising with the TGA throughout the assessment process including being on-site during a TGA insepction if needed
• Assisting with ‘close out’ activities and documentation as required.