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.
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.
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.
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.
Cross Contamination: Helpful Information for the Calculation of ADE/PDE Values
In practice, the conversion to PDE/ADE-based limits (e.g. in cleaning validation) leads to many issues. The new scientifically-based approach requires toxicological/ pharmacological data i.e. to precisely determine the necessary correction factors. The following documents and databases may be helpful.
Many manufacturing plants face problems during tableting. The most common problems are sticking, lamination or weight variations. But what are the reasons for this? Read more.
Scott Aldrich, member of the USP Dosage Forms Expert Committee, answered several very interesting questions regarding the USP chapters for testing of particulate matter during the ECA conference "Particles in Parenterals", 7-8 May 2013, Vienna. Please find the questions and answers here.
An FDA representative talked about the US-American authority’s perspective as concerns particulate matter in sterile drug products at the ECA conference "Particles in Parenterals" in May this year. Read more here.
New FDA Guidance for the Prevention of Cross Contamination of Beta-Lactam Antibiotics
In April the US authority FDA issued the finalised Guidance paper with recommendations on the separation of the manufacture of not-penicillin Beta-Lactam antibiotics. Read more.
An FDA Warning Letter dated February 2013 describes deviations identified during the inspection of an US-American company. Apart from the failure to adequately investigate and document OOS test results, failures in the stability program and deviations in the water purification are the main content. Read more.