Lead GMP and Validation Consultant PharmOut is delighted to welcome Marc Fini to the role of Lead Consultant. Marc has has over 15 years of experience in the pharmaceutical industry, principally in the roles of validation and compliance. He has experience in API, solid dose, liquids and blood products facilities and provided validation services to…
PharmOut is delighted to welcome Kathy Walsh to the role of Lead Consultant. Kathy has worked in the pharmaceutical industry for more than 14 years, accumulating broad knowledge in the practical application of GMP and quality systems in TGA and FDA – regulated environments. Her strong technical experience, underpinned by several scientific roles, allows her…
In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration. On January 1, 2015, the MDSAP pilot program was opened to manufacturers around the…
What are they and where did they come from? Air detectors were first developed in the textiles industry where autoclaves are used in a process called ‘heat setting’ for yarns and synthetic fibres such as nylon. In the textiles industry, autoclaves are used to improve and/or add certain properties to fibres, such as dimensional stability,…
At the beginning of last year (2014), I posed the above question “Should Requirements Traceability Matrices (RTMs) be formally controlled documents?” on LinkedIn because I wanted to get thoughts from people working in the pharmaceutical industry regarding how they went about it. I thank all those that have taken the time to respond. In essence,…
GSK has announced a AUD$31 million expansion to its manufacturing site in Boronia Victoria. The expansion will focus on high speed ‘Blow-Fill-Seal’ machinery specifically developed for aseptic packing of sterile pharmaceutical liquids. The new expansion will meet increased demands from emerging markets for Ventolin (salbutamol sulfate) nebules in particular China, Turkey and Brazil where patients…
Is your organisation having to start, or repeat, temperature mapping efforts due to increasing regulations on warehouse storage and distribution practices? Are you facing difficulties in maintaining control of the temperature distribution within your storage areas? Are you looking to implement a simple framework of validation testing that aims to establish a sound strategy and…
Dedicated Facilities Last week, I published a blog titled “Dedicated facilities or not?” and I surmised that trying to guess where regulations on cross-contamination were going, it was like gazing into a crystal ball. Well, the crystal ball was in Paris two weeks ago where 156 participants from 56 countries met on the topic of…
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