A new GDP guide has been published this month by PIC/S – the PIC/S Guide to Good Distribution Practice for Medicinal Products. The PIC/S GDP Guide is based on the 2013 EU Guidelines on Good Distribution Practice.
There are substantial differences between the current Australian requirements and those of the PIC/S Guide to GDP.
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 July.
This will means we have 46 participating authorities, …
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 …
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, …
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 …
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 …
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 …
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 …
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).
Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.
