GMP Trends and Analyses!

02.08.2021

Quality culture

Recognising and influencing three of the key features of quality culture. Please read more here

Validation of disinfection procedures in aseptic manufacturing

The tricky issue of exposure times. Please read more here

16.03.2021

Preparing for a data integrity inspection

Data integrity is one of the more recent, though still important, areas of interest in pharmaceutical company inspections. Please read more here

16.03.2021

Cleaning Validation Q&A

A selection of Q&As answered during the Live Online Training Cleaning Validation in September 2020. Please read more here

The long and winding Road of the Annex 1 Revision

The first draft of the current revision was already published for comment on December 20, 2017. What has happened since then? Please read more here

16.03.2021

How to save Time and Money in International Equipment Qualification Projects?

The regulations with regard to Qualification and Validation are different in the US, in Europe in China and other countries. Please read more here

16.03.2021

European GMP & GDP Forum – the largest Conference of its Kind in Europe

The first European GMP & GDP Forum will be held from 22-24 June 2021, both as an on-site meeting in Heidelberg, Germany, or Live Online. Please read more here

10.03.2021

Is Real Time Release Testing and Certification by the QP the next Generation Process?

RTRT is the ability to evaluate and ensure the quality of the product at the time of processing. Please read more here

10.03.2021

E-records Vulnerabilities

In the life science industry, surfaces pose different risks for the process depending on whether and how long they are in contact with the medicinal product. Please read more here

GMP Update 2020/2021 - NEW

The work environment and focus of regulatory agencies have changed, in some cases significantly, in 2020, particularly as a result of Covid-19. Please read more here

Read more … GMP Update 2020/2021 - NEW