GMP News - Pharmaceutical Technology


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.



Become an active part of the Conference "Particles in Parenterals"

The ECA Foundation's Visual Inspection Interest Group has been conducting the annual conference "Particles in Parenterals" for several years now. For the planning of the 2018 event you can become involved as an active part.



FDA Form 483 due to Particle Findings in a Product

The company Celltrion in South Korea received a so-called Form 483 report as a result of an inspection of the facility in May and June 2017. Amongst other things, it criticised particle findings in released products, insufficient environmental monitoring and deficiencies in aseptic activities. Read more about the deficiencies found during the inspection.



FDA Finalises Guidance on Emerging Technology Applications

The "Emerging Technology Applications for Pharmaceutical Innovation and Modernization" Guidance was already published as a draft in December 2015. Now the final Guidance is available.



Warning Letter due to Deficiencies in Filling System Design/Testing Particulate Matter

Due to deficiencies in the design of the filling system as well as the testing for particulate matter, the FDA has issued a warning letter to an Italian manufacturer of sterile products in Rome. Read more about the deficiencies resulting in a Warning Letter. 



The Role of Visual Inspection in the Release of Parenterals

According to the requirements of pharmacopoeias (e.g. EU or US), batches of sterile injectables must be 100% visually checked for defects. This test must be validated; because of its probabilistic nature, however, it is not 100% free from errors. How is this to be handled in the course of releasing batches?


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