GMP News - Pharmaceutical Technology


Water Systems in FDA Warning Letters

Among the FDA Warning Letters of the past two years there are every now and then letters citing deficiencies in water systems. On the bottom line the reason for objections is always the same. Read more.



Every fifth FDA Warning Letter includes deficiencies regarding Equipment

In 19 of the total of 92 warning letters of the last two years, shortcomings regarding equipment are part of the complaints. The most commonly cited issues are maintenance (including calibration), cleaning and the qualification of equipment. Read more.



Particles Filtration Not Acceptable

The EMA has recently added an interesting question to its Questions & Answers section. How acceptable is filtration of particles prior to the administration of a medicinal product for parenteral use? Read more.



Particles continue to cause major compliance problems and recalls

Recently, the FDA has published on its website a press release of the company Hospira about a voluntary recall due to particulate matter. Read more here.



EMA's Concept Paper on the Selection of suitable Sterilisation Processes

At the beginning of April 2014, the European Medicines Agency (EMA) published a concept paper which describes the need for a revision of the existing documents about complying with the current state of art with regard to terminal sterilisation and aseptic procedures. Read more here



ECA Working Group on Visual Inspection Founded

The European Compliance Academy now counts a new working group. In addition to the already existing working groups on validation, GDP, QC, rapid microbiology methods and the QP Association, a new group was created at the beginning of the year to address GMP Compliance in the visual inspection of parenterals. Read more here.



New FDA Guidance to Avoid Overfill of Vials

In March, the FDA published a new Guidance as draft which is supposed to limit overfill of vials with drug products intended for injection. Read more.



WHO publishes revised draft on the Guideline on "Hold Time" studies

The first version of the draft was published for comment already one year ago. Now, revision 2 of the paper has been published one year later for new comments. The new paper is much longer but also less clear in some parts. Read more.



Qualification and the new Annex 15 Draft

The revision of Annex 15 of the EU GMP Guideline has also consequences with regard to qualification. Some elements have been added, some are now more detailed. Read more here.



Deviations in Packaging are increasing

Packaging defects are a key problem of the pharmaceutical industry. According to assessments by the FDA and the Irish Authority, as reported by International Pharmaceutical Quality (IPQ), the number of deviations and observations made on packaging & labeling has been steadily growing - partly in a drastic way. Read more here.



News from the US on particles in injectables

Particles in medicinal products for parenteral use as well as the 100% inspection on particles stay in the focus of the US American authorities. There are some upcoming changes in the USP with respect to particle inspection, which you can find here.



Qualification, Requalification - frequent Obscurities

The terms qualification, requalification and monitoring are often mixed up, especially if the somewhat different language from ISO standards is used in the GMP environment. This can lead to misunderstandings that may result in problems. Read more.



Overview of the Requirements on WFI in the EU, USA and Japan

What are the different requirements on WFI in the EU, USA and Japan? The answer to this frequently asked question can be found here.



USP visual inspection expert answers question regarding AQL testing

Questions about the implementation or the need for AQL testing in the visual inspection of parenteral drugs are becoming more frequent. To get concrete answers to a specific question read on.



WHO revises Guideline for Maximum Hold Times

In July the WHO has released a revised draft of its new guideline for determining the maximum hold time. Read more.


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