GMP News - Pharmaceutical Technology


Glass Particles due to Delamination

The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk, especially when it comes to parenterals.



How often do HEPA Filters have to be changed?

In the pharmaceutical industry, HEPA filters are used as terminal filters for the processing or filtration of air in production spaces. They are mandatory in sterile production, although they are somtimes also used in the manufacture of solid or semisolid dosage forms. Amongst the HEPA or high-efficiency particulate filters are Filter Classes H13 to H14 (DIN 1822), the latter with a retention rate of 99.995%. But how often do HEPA filters need to be changed?



Maintenance Cycles of pharmaceutical Water Systems

To maintain the qualified state of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?



Indian Sterile Manufacturer receives a second Warning Letter

In March 2017, the FDA published another Warning Letter to an Indian pharmaceutical manufacturer due to GMP violations. The letter describes findings with regard to complaint handling, leaking of sterile products and the corresponding CAPA processing as well as on the non-compliance with quality agreements.



Visual Control by Doctor and Patient?

To avoid a supply shortage, batches of a lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer.



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.


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