GMP News - Pharmaceutical Technology


EMA publishes final Q&A Document on the use of PDE (HBEL) Values

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.



Insufficient water system design: warning letter in Mexico

Due to severe GMP violations, the US FDA has issued a warning letter after inspecting a Mexican pharmaceutical manufacturer. Major deficiencies have been found in the pharmaceutical water system as well as in microbial laboratory testing.



Warning Letter due to cross contamination 2018

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.



New Ph. Eur. Developments in the Visual Inspection of Injectables

Ph. Eur. chapter 2.9.20 on the visual control of parenterals is currently being revised. There are no major changes expected. What is much more interesting is the announcement of a new advising chapter. Read more about the new chapter 5.17.2 on visual inspection.



The new Annex 1 and 5 µm Particles

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.



FDA opens Docket on Continuous Manufacturing

In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.



Impact of the Annex 1 Revision on Pharmaceutical Water

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.



How a 483 turned into a Warning Letter for Celltrion in South Korea

The South Korean company Celltrion had received a so-called 483 FDA report as a result of inspections performed in May and June 2017. Deficiencies were mainly observed in the aseptic area. Due to the - in their opinion - insufficient answer to the 483 report, the FDA has now issued a Warning Letter.



Background: Hygiene Requirements in Air-Conditioning and Ventilation Technology

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.



Non-Compliance by Indian Drug Manufacturer: Cross Contamination

In the EU database for Non-Compliance Reports of European inspections, there is a new entry for the inspection of a pharmaceutical manufacturer in India from November 2017. Main focus of the findings: cross contamination.



New Edition of VDI 6022 Part 1: Hygiene and Hygiene Inspections of HVAC Systems

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.



Impressive Non-Compliance Report for Romanian Drug Manufacturer

The European Health Agency EMA publishes Non-Compliance Reports by GMP inspectors in their EudraGMDP database. A report of impressive deficiencies at a pharmaceutical manufacturer's site in Romania based on an inspection in summer 2017 is available there, as well.



Swissmedic's statement on how to handle discrepancies between EU and PIC/S GMP

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



Alarms and Delay Times from a GMP Viewpoint

Up-to-date monitoring systems produce vast amounts of data, e.g. pressure, humidity and temperature in clean rooms. In pharmaceutical production practice, there are different approaches to handle this electronic data - alarms especially. Not all of them are ideal from a GMP viewpoint.



Effects of the Annex 1 draft on 100% inspection of Parenterals

After many postponements, the long awaited Annex 1 draft of the EU GMP Guideline has finally been published on 20 December, 2017. While the chapters on integrity testing and visual inspection of injectables used to be rather short, the draft now contains several updates.


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