GMP News - Pharmaceutical Technology

In April 2018, the EMA published the final version of the Q&A document on the use of Health-Based Exposure Limits (HBELs) without special notice. The draft version had become necessary in 2016 because the EMA had generated widespread uncertainty within the pharmaceutical industry with their guideline on setting these limits (PDE values as well). Find out more about the EMA HBEL Document.

In March 2018, the FDA has issued a Warning Letter to a manufacturer of medicinal products in the Dominican Republic due to various GMP violations. One of these violations was cross contamination.

In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.

The long-awaited draft of the new Annex 1 was published in December 2017. Besides mainly contents concerning sterile production, it also contains various updates on the manufacturing and distribution of water to be used in pharmaceutical production.

The guideline VDI 6022 Part 1 underwent substantial revisions and now contains many new obligations for manufacturers, planners, constructors, operators and supervisors of HVAC systems and air conditioners.

In January, the VDI published a completely revised edition of part 1 of the VDI 6022 series. The guideline deals with hygiene for HVAC systems with the objective of preventing negative effects on room air.

In December, the Swissmedic - the Swiss Agency for Therapeutic Products, has published a short statement on how to handle differences between different GMP guidelines.