GMP News - Pharmaceutical Technology

The topic 100 percent visual control of parenterals constantly raises new questions, especially as concerns the use of automatic inspection machines or if statistical issues emerge concerning AQL inspections. To find some of these questions and answers by Dr. Tobias Posset (Head of Production Support at Roche Diagnostics) please read here.

In August, the WHO published the third revision of the draft guidance document on the design of hold-time studies. In many parts, the new version has become much clearer than the previous version. Read more.

There are new chapters in the USP regarding testing of subvisible particles. Chapter Subvisible Particulate Matter in Therapeutic Protein Injections <787>  became official August 1, 2014. The informational chapter <1787> was developed to support chapter <787> and will be published in USP 38 in November and become official on May 1, 2015. Read more.

In the following News, you will find questions on pharmaceutical water preparation and distribution frequently asked during our courses, as well as their respective answers. Read more here.

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.

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.