EU Commission publishes long-awaited EU GMP Guide Chapters 3 and 5
The EU Commission has published the long-awaited, revised chapters 3 and 5 of the EU GMP Guide. The change focuses on the prevention of cross-contamination as well as on the statement concerning the need for dedicated facilities. Continue reading.
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.
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.
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
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.
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.
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.
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.
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.