GMP Auditing
This article was originally published in SRA
Executive Summary
TGA guidance published
TGA guidance published
The manufacture assessment section (MAS) within the Therapeutic Goods Administration (TGA), [formerly the GMP auditing and licensing section (GMPALS)] has recently posted on the TGA website, detailed information on all aspects of GMP audits on medicine manufacturers1. These audits are performed regularly by the manufacturer assessment section to ensure that Australian and overseas manufacturers wishing to supply therapeutic goods in Australia are in compliance with the appropriate manufacturing principles, including codes of good manufacturing practice, necessary to obtain a licence. The information provided covers audit frequency and scheduling, audit duration, the audit team, typical pre-audit, audit and post-audit activities and the appeals and complaints procedure.
Recent actions as a result of audits
Recently two high-profile cases have arisen highlighting the need for and value of TGA inspections.
In what is the largest recall in Australian history, involving over 1700 products, the TGA has suspended the licence held by Pan Pharmaceuticals Ltd of Sydney to manufacture medicines. This extends for a period of six months with effect from 28 April 2003, because of serious concerns about the quality and safety of products manufactured by the company3. The suspension followed audits of the company's manufacturing premises, which revealed widespread and serious deficiencies and failures in the manufacturing and quality control procedures, including the systematic and deliberate manipulation of quality control test data. The TGA has also taken the decision to recall all batches of medicines manufactured by Pan Pharmaceuticals Ltd since 1 May 2002 and that are being supplied on the Australian market. Detailed information, including question and answer documents, has been published on the TGA website for the benefit of consumers, industry and overseas regulators.
Previously in April 2003, Curacel International Pty Ltd became the first Australian drug company to be convicted of manufacturing counterfeit medicines, following criminal investigations by the TGA's surveillance unit2. The company's manufacturing licence was revoked in 2001 and in April 2003 the company was convicted of manufacturing counterfeit medicines, carrying out unlicensed steps in the manufacture of medicines and manufacturing and supplying unapproved medicines, which included use of a `schedule 4 poison' (prescription-only medicines) in OTC products and re-bottling and re-labelling of vitamin tablets to include a bogus batch number and extended expiry date.
CARMEN LANGLEY
References
1. Audit of medicine manufacturers, TGA website, www.health.gov.au/tga
2. Ministerial press release (Hon Trish Worth MP), 23 April 2003, www.health.gov.au/mediarel
3. Pan Pharmaceuticals Limited - Regulatory Action and Product Recall Information, www.health.gov.au/tga