Quality Management Systems (QMS), be it ISO or PIC/S, mandate that system reviews must occur. Product Quality Reviews (PQR) can provide the ideal platform not solely to fulfill a compliance requirement but to give real insight into the performance of critical QMS aspects. The premise of any QMS procss and PQQR leverage this where: Regulatory…
The debate on the number of batches used to determine if a process is validated or not has come under some scrutiny since the update of the US FDA’s Guide to Process Validation in 2011. As a result of the update, industry has tried to come up with a number of ways to help to…
Kirkpatrick 4 Levels of Learning Evaluation Model – an introduction for companies seeking to further develop their personnel. In a world where a company’s success is determined by the knowledge, attitude and work ethic of the staff within it, how do we ensure that the company can adapt, grow and succeed in this ever-changing environment?…
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…
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