A European multinational pharmaceutical manufacturer in China (Beijing), recently engaged SeerPharma to conduct a mock TGA GMP inspection in preparation for an impending TGA audit. The operations had been inspected by the TGA in the past.
A leading sterile pharmaceutical manufacturer in India engaged SeerPharma to assist in responding to a recent TGA GMP audit. As part of its response to the TGA, the company requested SeerPharma to visit their site in Madhya Pradesh. SeerPharma was tasked to assess the clients’ sterile facilities, documentation, quality management system, risk...
SeerPharma has been assisting an Indian Pharmaceutical company based in Gujarat with GMP facility design considerations. The company has now requested SeerPharma inspect their Operations against the PIC/S Guide to GMP, to help them achieve PIC/S GMP compliance. With GMP Clearance from the TGA and other regulators, the company will be able to...
Following a successful pilot program conducted in 2015-16, the Therapeutic Goods Administration's (TGA's) Pharmacovigilance Inspection Program (PVIP) has been implemented as an initiative to help sponsors of medicines to meet their pharmacovigilance obligations.
SeerPharma is helping sponsors prepare for the inspections.
The TGA has published details of the 12 month graduated transition period to PIC/S Guide to GMP PE 009-13, commencing 01 January 2018. The key changes and a transition plan have been summarised in tables by chapter and appendix and are linked here for your convenience.
The TGA announced on 13 September 2017 that it will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens from 31 December 2017.
This post was first published in July 2017 and has been updated to reflect changes.
The Therapeutic Goods Administration (TGA) is part of the Australian Federal Government’s Department of Health and is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods, including medicines
Good Manufacturing...
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...
Health World Limited has grown to become a market leader and one of the most trusted suppliers of Complementary Medicines in Australia and New Zealand. Much of Health World Limited’s success is due to its strict adherence to its mission of helping people live happier, healthier lives and the company uses SeerPharma for its GMP training.
It is imperative that Pharmaceutical companies have a good handle on how to perform Product Quality Reviews (PQR). In fact, effective PQR’s are necessary in demonstrating GMP compliance to regulators such as the TGA and FDA (Annual Product Review).
