GMP News - Pharmaceutical Technology

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.

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.

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.

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.