GMP News - Pharmaceutical Technology


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.



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.



Capping, Sticking & Weight Variations - tableting problems

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.



USP expert answers questions regarding particulate matter testing

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.



Particles in Parenteralia - FDA’s perspective

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.


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