Fritz Röder

Defect evaluation lists and defect pattern libraries are popular GMP documents that have been used for more than 45 years. They serve as a rationale for the quality assessment of individual batches and set quality standards for the manufacture and testing of pharmaceutical products.

Pharmaceutical water systems are used for a number of different applications by pharmaceutical manufacturers. These include, for example, the cleaning of various pieces of equipment, the generation of pure steam and the use of water as an ingredient for solid, semi-solid and liquid medicinal products.

The monitoring of critical parameters is largely automated and is part of the plant control system. In the event of a critical system alarm (e.g. TOC outside of tolerance limits), the control system also performs the system shutdown or the transition to a safe operation mode.

Pharmaceutical water is used in the manufacture of medicines, vaccines and other pharmaceutical products. High water quality is essential to ensure the safety and efficacy of the final products. In order to ensure that the quality is maintained at all times, there are many parameters that need to be monitored. In today's article, we look at the importance of physicochemical monitoring of pharmaceutical water.

Pharmaceutical water has a unique position in pharmaceutical industry. As raw materials and excipients are only used after quality control and subsequent release, pharmaceutical water is used immediately after production. For this reason, pharmaceutical water is considered extremely critical. Three types of water are of particular interest: Drinking water as source water, purified water (PW) and water for injections (WFI). In today’s feature we report on drinking water as source water. In future LOGFILES, we will report on PW and WFI.

Pharmaceutical water occupies a unique position within the pharmaceutical industry. Whereas raw materials and excipients are used only after quality control and approval, pharmaceutical water is used immediately after production. For this reason, it is considered extremely critical. Three types of water are of particular importance: potable source water, purified water (PW) and water for injection (WFI). In this issue we will focus on PW, while a future issue of LOGFILE will cover WFI.

Pharmaceutical water plays a distinctive and vital role in the pharmaceutical industry. Unlike raw materials and excipients, which undergo quality control and approval before use, pharmaceutical water is used immediately after production. For this reason, it is considered extremely critical. Three types of water are particularly important: potable source water, purified water (PW) and water for injection (WFI). In this feature we focus on WFI. Two previous LOGFILES have already reported on drinking water as source water and on PW.

What are the key considerations for gas distribution systems for pharmaceutical gases?