It is not unusual for Pharmaceutical Quality Systems (PQS) to be perceived, as ‘expensive’ and ‘non-value adding,’ by some areas of a GMP organisation. Often managers with Lean or Six Sigma backgrounds struggle to …
On December 12 and 13, 2012, the MHRA held its annual GMP Symposium. I was able to attend this event and have captured some of the major themes within this blog.
December 12 – Good …
The TGA has released its long-awaited response to the consultation on proposals for reform of pre-market assessment requirements for medical devices. The initial proposals were released for consultation in late 2010.
A number of reforms …
In June 2011, the Australian and New Zealand Governments announced their agreement to proceed with a joint scheme for regulation of therapeutic products (that is, medicines, medical devices, biological and others) to be administered …
The PIC/S meeting in Kiev discussed and agreed changes to PE009-9 to support the harmonisation of GMP guidance documents. PIC/S code of GMP PE-009-10 was issued by PIC/S on the 11th December, and whilst …
This concept paper addresses the need to update Annex 17 (Parametric release) of the EU GMP Guide. At the time the original guideline was adopted (January 2002), the main foreseen application area was sterility …
Pharmaceutical Cleanrooms | Cleanroom Design Flaws: 12 things that should no longer be seen in cleanrooms | Over the past few years, I have walked through many different clean rooms, both old and new, …
The advertising of therapeutic goods to consumers and health professionals is administered via a co-regulatory system which is representative of all key stakeholder groups, namely consumers, health professionals, the regulated industry sectors, the media, …
What makes a cleanroom a clean room?
Like anything technical, how a cleanroom works is essentially basic, but wrapped up in a whole lot of jargon, standards, rules and regulations. The basic principles are actually …
I have always said that Cleanroom Technology is not rocket science. Although it seems the modern cleanroom was developed to assist with the progression of rocket technology.
Working out of Sandia National Laboratories, Willis Whitfield, …
