GMP News - Pharmaceutical Technology


USP Draft Chapter <1062> "Tablet Compression Characterization"

The USP General Chapters—Physical Analysis Expert Committee proposes a new general chapter to describe the basic principles and practices used in the characterization of tablet compression. Read more about the proposed new USP chapter <1062> Tablet Compression Characterization.



USP announced Major Revision of General Chapter <1217> "Tablet Breaking Force"

The United States Pharmacopeia (USP) Expert Committee on General Chapters - Dosage Forms announced a major revision of general chapter Tablet Breaking Force <1217>. Comments can be submitted until October 15, 2016. Read more about the planned revision of USP general chapter <1217>.



Current Considerations on Pharmaceutical Water Systems and Ozone

In pharmaceutical water systems, ozone is an effective method to keep microbiological contamination under control. In the course of cold production (and storage) of WFI, which will be allowed as of April 2017, ozone will play an even bigger role.  When ozone is being used to sanitize a piping system, its effect has to be verified. Learn more about the classification of Ozone Measurement in Piping Systems.



Danish Manufacturer receives a so-called Untitled Letter from the FDA due to Deviations from GMP

A Danish pharmaceutical manufacturer has received a so-called "Untitled Letter" from the FDA after an inspection at his production site in Denmark. The letter was issued because of deviations from diverse GMP rules. Read more about the definition of an Untitled Letter and the GMP violations identified.



Warning Letter to a British Manufacturer: Cross Contamination, Pharmaceutical Water and Particles

The US Food and Drugs Administration (FDA) has issued a Warning Letter to a British API manufacturer. They criticized cross contamination by penicillin products, deviations regarding pharmaceutical water and foreign particles in the product. Read more about the major deviations in this Warning Letter.



New Q&A Document on the Visual Inspection of Parenterals available

The ECA's Visual Inspection Group has developed a new document with answers to frequently asked questions. This new Q&A document is now available for download on the Group's website. Read more about frequently asked questions in the visual inspection.



Is AQL Testing required within the 100% Visual Inspection?

One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspection of parenterals. The answer is: basically, "yes".



EMA publishes Q&A Document on Production of WFI not obtained by Distillation

The revision of chapter 0169 of the European Pharmacopoeia will introduce in Europe as of April 2017 the possibility to produce WFI using other techniques than distillation. However, many questions are still unanswered like for example how the robustness of the new procedure compared to distillation should be demonstrated. The now published paper has been therefore highly anticipated. Read more here.



WHO publishes Qualification Guideline for Comment

The WHO is currently revising its validation guidelines and has recently published a superordinate umbrella guideline. Now, an independent chapter on qualification was published for comment.



ECA Visual Inspection Groups works on new FAQ Document

The advisory board of ECA's Interest Group for Visual Inspection is working on a revision of a document with frequently asked questions with regard to visual inspection of parenterals.



Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia

The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes.



Case Study - Quality Metrics at Aenova: Report from the Pharma Congress 2016

Quality Metrics are a hotly-debated topic. At the end of July 2015, the U.S. FDA released a Draft Guide entitled "Request for Quality Metrics - Guidance for Industry". On the occasion of a keynote presentation at the Pharma Congress 2016, Dr Andreas König - Senior Vice President at Aenova - talked about the practical implementation and the challenges. Read more about Aenova's case study.



WHO defines Requirements on Zones E and F

In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It also contains for the first time a definition for microbial requirements with regard to the zones E and F. Read more about the ventilation sytems recommendations.



WHO issues revised Guideline on HVAC Systems

The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of non-sterile forms. As most guidelines on this topic address the requirements for sterile dosage forms, the previous version was gladly accepted by industry. Learn more about the revised guideline on HVAC systems.



EU GMP Annex 1 Revision 2016 - what does the pharmaceutical industry expect?

Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim talked in his keynote speech at the Pharma Congress 2016 about the revision of Annex 1 of the EU GMP Guide. Read here what the pharmaceutical industry expects form the new Annex 1.


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