- Annex 1
- Sterile Filtration
- PUPSIT
- Filter Technology and Test Methods
- Product-specific Filter Validation

Content

Aseptic manufacturing including sterilization via filtration has become increasingly important with modern biological medicinal products and is now an integral part of daily production…

– Annex 1
– Contamination Control Strategy
– Quality Risk Management
– Aseptic
– Sterile

The kickoff event for the online seminar series on the topic of Annex 1 recently took place. With around 100 participants, it was met with great interest. The goal of the first online seminar was to provide an insight int…

We offer the ISPE D/A/CH Online Workshop 'Pharma´s Journey to Digital Manufacturing (OWN it - DRIVE it - WIN it)', which is still in great demand, as a virtual online Workshop.

Speakers have already confirmed their participation and the agenda is in progress to be only slightly amended for the virtual…

About this Workshop

The pharma industry is undergoing a significant transformation due to digital technologies. Techniques such as visualization, modeling, automation, machine learning and artificial intelligence are dematerializing traditional processes and facilities, and drive productivity through…

The appearance of the new European monograph on the production of Water for Injections (Water for Injection, WFI) is the result of discussions, analyses, and conversations.

In this monograph, in the Production section, membrane processes for the production of WFI are now listed as an equivalent alter…

Under this title, we address topics that move the pharmaceutical industry and drive us, with our shared focus on pharmaceutical production. Looking ahead and working on new technical and GMP-compliant solutions today is clearly evident in the area of sterile and aseptic manufacturing.

By 2025, every…

Everywhere, media and lectures convey to us that the pharmaceutical industry is lagging behind in transforming new technologies into the production environment. Meanwhile, other industries are already further along digitally.

The pharmaceutical industry has also been undergoing upheaval since the adv…

In 1980, technically oriented employees of the pharmaceutical industry in the USA founded ISPE. It is a globally active organization focused on GMP-oriented training and efficiency enhancement in pharmaceutical manufacturing processes.
In 1993, 13 years after the founding of ISPE in the USA, engineer…

The topic of containment (ranging from light to high levels) is moving the pharmaceutical industry. Many newly introduced drugs are effective even in low doses – their active ingredients are highly potent. For patients, this development is an opportunity; for manufacturers, it is also a challenge…

Sharing Knowledge

The regulatory requirements in the manufacturing pharmaceutical industry apply across the entire value chain, for the benefit and protection of the patient. Knowing these requirements and implementing them in practice in compliance with regulations demands a lot from employees; this…