GMP News - Pharmaceutical Technology


Warning Letter to Pharmaceutical Manufacturer in Singapore due to Leaking Sterile Containers

A manufacturer of sterile ophthalmics in Singapore has recently received a Warning Letter of the US FDA. Container leaks and the associated risk of microbial contamination were the main points of criticism.



FDA Warning Letter: Visible Particles and Visual Inspection

During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.



Nitrogen Use in pharmaceutical Production

Nitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. Parameters and limits for nitrogen have to be defined by the pharmaceutical users themselves.



Requirements for compressed Air in the Pharmaceutical Industry

In many cases, gaseous media used such as compressed air contact the product and are thus, by definition, quality relevant, and in particular, of course, in the case of sterile products. However, compared to e.g. the liquid medium pharmaceutical water, they are much less explicitly specified. Pharmaceutical users have to define their requirements for compressed air themselves.



USP Q&A Paper on Pharmaceutical Water

The website of the US Pharmacopoeia (USP) comprises a document with frequently asked questions and answers on the subject of pharmaceutical water. The not very well known page contains some very interesting points.



Frequently Asked Question: How often does a Reverse Osmosis have to be sanitised?

Reverse osmosis as a main barrier to all types of impurities plays an essential role in both the production of Purified Water (PW) and cold WFI production. In the pharmaceutical industry, this module has to be heat sanitisable. Now the question is how often heat sanitisation has to be performed?



Use of Hoses in the Pharmaceutical Industry

Hoses are more often used than one thinks. On the one hand they are used in routine operations, on the other hand they can also be utilised as interim solution before a new pipe is drawn. They then fall into the first case situation. While one pays more consideration to pipes, their material quality and surfaces, hoses are often neglected. But what about requirements for hoses? Are there any?



EMA revises Guide on Pharmaceutical Water

According to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use".



MHRA's Interpretation of Cross Contamination & PDEs

The British inspectorate MHRA has recently published a comprehensive document that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept must be applied. One essential element of that concept is EMA's Q&A Paper describing when a product should be classified as highly active. This Question & Answer Paper can be commented on until the end of April 2017. Read more here.



How to perform Cleanroom Monitoring

The premises dedicated to the manufacture of medicinal products have to be monitored. Depending on the type of product to manufacture and whether it is a sterile or a non-sterile medicinal product, the requirements for cleanroom monitoring are more or less demanding.



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.


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