For Australian and New Zealand Manufacturers PIC/S Version 13 is due this year, aside from significant changes in Part 1, there are also significant changes in Annex 11, Computers Systems and Annex 15, Qualification and Validation. We plan to help you get ready now for the pending change. Following on from the highly successful PIC/S…
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…
In December, I attended my absolute favourite GMP event of the year, the Medicines & Healthcare products Regulatory Agency (United Kingdom) (MHRA) GDP / GMP symposium in London, aside from having the opportunity to drop into our London office and meet local team of GMP experts. I was once again had an opportunity to attend a…
I want an innovative cleanroom design, the use of the word “innovation” is perhaps the most overused ‘buzz’ word in the design and documentation of health sciences facilities, the intent is certainly not over-used, in the sense of the recognition of the increasingly evident acceptance and embrace of concepts driven as simple solutions to complex…
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…
On October 31, the ODC released an online smart form and “flat” paper forms to apply for a cultivation, production or research medicinal cannabis licence. This online form can also be used if you seek a manufacturing licence but ONLY if you are also applying for a cultivation and/or production licence or a research licence….
Last week, Bob Tribe, who is an Executive Consultant with PharmOut spent the week in Riyadh, Saudi Arabia assisting the GMP Inspections Section of the Saudi FDA get ready to lodge an application for PIC/S membership. This involved a review of the systems and procedures of the GMP Inspections Section, including its Quality System, against…
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