The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. It is the equivalent of the TGA (Therapeutic Goods Administration) here in Australia. Both administer compliance matters in Good…
On 1st of January 2017, revision 13 of the PIC/S Code of GMP for medicinal products (PIC/S PE 009-13) entered into force. Four Chapters of PIC/S PE 009-13 were revised to align with the current EU GMP code and ICH Q10. This was conducted “with some minor differences in terms of language“. The PIC/S website…
Quality Management System Documents A well-written document with a comprehensive and well-designed Quality Management System (QMS) can be a manager’s best friend. They are our daily guidance and instructions for our staff, the ‘go-to’ during an audit or inspection, and the first reference point when inducting new staff. But getting to a ‘good’ document like…
In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry. As the name suggests, it is a glossary of DI terms where the definitions are further explained with some context to aid in applying the existing regulations available. This is an update to their…
PIC/S have just released a new, responsive website that allows for easy viewing on both desktop and mobile devices. The website reflects the change from the black and white PIC/S logo to the red, blue and white tones. The layout of the site is more intuitive and new sections include members only access to the…
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