GMP News - Pharmaceutical Technology

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

Fluoropolymers have an extremely high chemical stability. However, this stability also means that once they enter the environment, they can remain there for a very long time and cause environmental damage. The EU plans to restrict or ban perfluorinated and polyfluorinated alkyl substances (PFAS), which include PTFE, for example, in the future. This would have serious consequences for plants in the pharmaceutical industry, for example, where PTFE is used as a material for seals.

In October, the US FDA issued a Warning Letter to a US sterile manufacturer due to numerous GMP violations. The inspection, which had already taken place from March to April 2022, had revealed numerous deficiencies. The main reasons for the Warning Letter were cross contamination and microbiological contamination of products.

In April, the US FDA inspected a manufacturer of OTC products in Mexico. Due to the deficiencies found, in particular the unacceptable risk of contamination, the production was stopped.

Both in the production of purified water and in the production of WFI with membrane technology, reverse osmosis plays an essential role as the main barrier to impurities of all kinds. For pharmaceutical use the systems including the RO modules should be hot sanitisable. Chemical sanitisation of RO modules is no longer considered state of the art. But how often should hot sanitisation be carried out?

Typically, the room humidity is also regulated and controlled in cleanrooms. For this purpose, the outside air is dehumidified in summer and humidified in winter, especially in dry cold weather, to ensure a minimum humidity in the cleanroom. So, how exactly is the room humidification for GMP-regulated areas carried out? What quality should the evaporated water or its condensate have? These questions are frequently asked and controversially discussed.

The continuous manufacture of medicinal products is a young, spreading type of modern pharmaceutical production. In contrast to classical batch manufacturing, these processes run continuously, i. e. dosing and product withdrawal run uninterrupted and are continuously monitored. A recent USP article discusses what release testing might look like.