Many manufacturers want to know how often they will be inspected – which can be a complex question to answer. The TGA employs a risk-based approach to the frequency of manufacturer inspections, in addition to numerous other factors. How does the TGA determine inspection frequency? The TGA uses inspection frequency matrices to guide the frequency…
If I had a dollar for every time I was asked this question, I could retire! Thankfully, the TGA issued their commitment to timeframes on the 1st of May 2013. These are the TGA’s performance targets and are subject to cooperation of the TGA GMP inspector, manufacturer, sponsor and in some cases, international regulatory authorities….
There can often be some confusion between the terms ‘Critical’ and ‘Major’ deficiency. On the 1st May 2013, the TGA helped to answer this question by issuing a list of typical inspection deficiencies and their risk categorisation! This is of immense help to the industry. Critical deficiency A critical deficiency is a deficiency which has…
The impact of recent changes to the “Internationally harmonised requirements for Batch Certification”? The European Union (EU) has reformed the rules for importing active pharmaceutical ingredients into the EU for medicinal products for human use. As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing…
Site Master Files and Quality Manuals: Differences I am often asked by new Australian-based manufacturers seeking a TGA manufacturing license and implementing a Quality Management System (QMS) what the difference is between a Site Master File (SMF) and a Quality Manual. The confusion is understandable given that both documents appear to contain similar information. So…
Filter Specifications and Standards Following a review by the CEN (European Committee for Standardisation), there have been changes to the following European Standards providing changes to the classifications of filters, allowing clear definition and clarity to the specification and efficiency calculations for filter classes; EN779: 2012 ‘Particulate Air Filters For General Ventilation – Determination of…
On 29 July 2009, Australia’s Therapeutic Goods Administration (TGA) adopted the PIC/S Guide to Good Manufacturing Practice PE009-8. One of the single biggest changes from the previous Australian Code of Good Manufacturing Practice was, and remains, the codification of Quality Risk Management (QRM). The industry was unprepared for the impact of QRM and, although the…
It is not unusual for Pharmaceutical Quality Systems (PQS) to be perceived, as ‘expensive’ and ‘non-value adding,’ by some areas of a GMP organisation. Often managers with Lean or Six Sigma backgrounds struggle to make the correlation between GMP and process efficiencies. ICH Q10, PQS, is a guidance document first released for industry comment in…
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