Japan and Korea join PIC/S PharmOut congratulates the MHLW and the PMDA of Japan’s Prefectures and Korea’s MFDS on being invited to join PIC/S as of the 1st of July. This will mean we have 46 participating authorities, not sure how these fits with the recent Dr Margaret Hamburg talk in London to the MHRA…
This White Paper explores the methods of preventing contamination and cross-contamination in manufacturing facilities. Purpose To identify potential contributors of contamination and cross contamination. To offer ideas on how to minimise and prevent contamination and cross contamination occurring within a manufacturing facility. Audience Project Managers Validation professionals QA professionals Prerequisites Familiarity with Annex 15 Qualification…
The National Commission of Audit Recommendation 19 could significantly improve the cost and time to market for new drugs. The Commission cites the example of Atorvastatin, currently the most highly prescribed and highest cost to government medicine in Australia, New Zealand only pays $2.01 in comparison to the price paid in Australia of $38.69. The Commission recommends many changes are be…
Validating an autoclave Purpose Validating an autoclave is a daunting and time-consuming task. This white paper details the tricks, tips and traps to such a validation project from how to choose your control to which load configuration to use for your validation runs. The white paper presents very practical steps to validate an autoclave by…
PharmOut is pleased to congratulate Anlit for achieving GMP Certification from the Therapeutic Goods Administration in Australia. Anlit is an innovative developer and producer of quality consumer vitamins, minerals and dietary supplements for children. Since 1990, Anlit have been dedicated to developing, manufacturing and marketing high quality products to ensure the health and nutrition of…
PharmOut is delighted to welcome Ashley Isbel to the role of Lead Consultant. Ashley has been with PharmOut for more than 5 years and has consistently delivered above and beyond what is required. As an expert in Validation and Process Engineering Ashley has directly or indirectly through training delivery contributed to the development of many…
A New Year a New GMP quiz! You’ve probably already done the old quiz, so test your updated GMP knowledge with the latest PharmOut 2016 GMP quiz. All new questions have been developed as well and a handy little hint is available for those who keep a copy of the PIC/S guide handy. Feeling like a…
The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
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