GMP News - Pharmaceutical Technology


Sterile Manufacturer receives Warning Letter from US FDA

Following an FDA inspection, a manufacturer of sterile medicinal products in the UK has received a Warning Letter due to serious violations of GMP. As often in such cases, the inspection was preceded by another one where GMP deviations had been observed but to which the company had responded insufficiently. Read more about this Warning Letter here.



WFI obtained by non-distillation methods - What are the Next Steps?

The European Pharmacopoeia's revised monograph 169 on water for injection (WFI) will become effective by the 1st of April 2017. For the first time in Europe, a monograph will allow the production of WFI with other methods than distillation. But there are still unanswered questions, e.g. how to deal with HPW systems which have been already producing water with WFI quality. Read more about the revision of the Monograph on WFI.



The Risk of Biofilm

Even in well-maintained water systems, repeated sudden and brief OOS/OOT results can occur in the microbiological monitoring. If we talk about typical water bacteria, biofilms in the systems are almost always responsible for these results. Read more about the risk of biofilms.



FDA presentation at the ECA Conference Particles in Parenterals

At the Particles in Parenterals Conference Dr Stephen Langille from the US FDA gave a talk on the FDA's current thinking with regard to the visual inspection of medicinal products for parenteral use.



Critical Impurities in Pharmaceutical Water

Water is an essential raw material in pharmaceutical production. It is with great effort that the required qualities (such as WFI or AP) are produced and maintained in storage and distribution systems. However, it is often neglected which impurities in the raw water are relevant for the production of pharmaceutical water. Yet this knowledge is crucial for the design of a water purification plant and for the validation of the complete system.



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.


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