Cultural Change Methodology as a Competency – an article about change management challenges, skills, and strategies for success. Why do we resist change? What does this mean in our regulated environment? I am not referring to process changes driven through your QA Change Control procedures; rather, business, process, or cultural change initiatives that need to…
The FDA have released a preliminary report on the New England Compounding Centre in response to the recent fungal meningitis outbreak. The 483 includes details that staff often turned off the cleanroom air conditioning overnight and that dust from a nearby recycling plant was getting into the facilities air conditioning system. For those microbiologists among us,…
Guidelines for Complementary Medicines (ARGCM) The Australian Regulatory Guidelines for listed medicines and registered Complementary Medicines was published in May 2020. It replaced ARGCM V8.0. History of the ARGCM The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) was first published in 2001 to provide information on the supply and use of complementary medicines. The TGA is…
As you may have heard in recent reports from the US, the deaths of 7 people and the illness of a further 91 from fungal meningitis have been traced to a batch of steroidal spinal injections prepared by a New England compounding company. This article from The New York Times, discusses the incident, the background…
Chapter 7 “Contract Manufacture and Analysis” will be re-titled as “Outsourced Activities” from the 31st of January 2013. The revision will provide further clarification and guidance on “any activity covered by the GMP guide that is outsourced”, rather than just “contract manufacture and analysis”, as per the previous version. This update also aligns the context…
As of the 31st of January 2013, Chapter 1 will come into operation titled as “Pharmaceutical Quality System” in order to align with the concepts and terminologies described in the ICH Q10. The current version of Chapter 1 describes “Quality Management” and how it incorporates Good Manufacturing Practice (GMP). The new revision further clarifies that…
History of TGA & Medsafe ‘Early Warning System’ project discussions One of the projects identified by the TGA and Medsafe when they formed ANZTPA in 2011, was to develop an early warning system to assist in the communication of potential safety issues with therapeutic products. This article provides a historical overview of the efforts of…
On August 10th, the US Food and Drug Administration (FDA) issued a statement that signalled the completion of their evaluation of CSL’s corrective actions in response to the Warning Letter received in June 2011. CSL’s site at Parkville received the FDA warning letter due to “a number of significant objectionable conditions relating to the facility’s…
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