GMP News - Pharmaceutical Technology

After the WHO had released the second draft of the guideline for the design of hold time studies in March already, it now released the final version as part of the Technical Report Series 992. Find out more about the Guideline for Hold Time Studies.

The VDI published the standard 2083, part 2 final in April. In principle, this standard summarises the requirements on clean rooms according to VDI 2083 part 1and 3 as well as DIN EN ISO 14644-1 and -3 together and indicates the time intervals at which compliance with the requirements should be checked. Read more about VDI 2083 part 2.

In an EDQM paper published in March 2015 the topic production of WFI by means of membrane-based technologies is discussed again and not excluded any more. Read more about WFI from membrane-based technologies.

With the new biocidal products regulation from 2013 in-situ generated ozone now also falls into the scope of this directive. Ozone generation systems with a biocide application (such as disinfection of pharma water) thus require an approval after the transitional period expires in the September 2017. The ozone registration group is active for this purpose. Read more about the Ozonization of Pharmaceutical Water and the Biocidal Products Regulation.

In the operating routine the expressions pure steam as well as clean steam are used repeatedly. But it is seldom clear whether the same is meant with these two expressions. Is there a difference at all between them? Find out more about the Difference between pure steam and clean steam.

At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes the requirements on the manufacture of sterile dosage forms. Read more.

The long-awaited USP Chapter <1790> regarding the 100% visual control of injections has been issued in the Pharmacopeial Forum 41(1) for commenting. Read on.