What is a clean room?
A cleanroom (GMP cleanroom), in my mind, is a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. This blog will …
Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others …
To start understanding mRNA vaccines we need to begin with talking about viruses. Although viruses fall under the field of microbiology, they are not considered as true living organisms in the conventional sense, as they cannot exist without a …
On 1 January 2021, ANVISA, Brazil became the 54th member of PIC/S. Like all other PIC/S members, both ANVISA and Brazil’s pharmaceutical industry will realize a wide range of benefits of PIC/S membership, particularly at this time of the …
The first references to the term “dedicated facility” appeared in GMP literature in the early 2010s in response to potential cross contamination risks of manufacturing toxicologically sensitive products in shared facilities. The WHO Technical Report Series, No. 957, 2010 …
New PIC/S GMP version 13
The TGA finally formally announced adoption of the new PIC/S GMP version 13 (PE009-13, 1 January 2017) which is scheduled to commence on 31 December 2017!
In this public statement the TGA announced: from 1st January 2018, the …
Data integrity might appear to be a “buzz” word for regulators and management, but as the Volkswagen scandal involving 90,000 cars and the Qantas “tailstrike” incident indicate, it is of paramount importance in all industries.
In the pharmaceutical and medical …
