GMP News - Analytical Quality Control

The USP plans the publication of a new general chapter on quality requirements for inhalation and nasal drug products. At the same time, another chapter should deal with the performance characteristics of these products. More information can be found here.

Recovered / recycled solvents may be used in the manufacture of herbal preparations. But which quality requirements apply to such solvents? According to the "EMA/HMPC Concept Paper", a new guideline on the standards to be used should be elaborated. Read more in this News.

The procedures described in the pharmacopoeial texts for the determination of the density of powders now were judged to be equivalent in the three ICH regions Europe, USA and Japan and were published in the ICH Guideline Q4B Annex 13. You can obtain more information in this news. 

The second edition of the ISPE GAMP® Good Practice Guide for Laboratory Computerized Systems was published in October 2012. Thus, a connection is also established between laboratory equipment and the GAMP® 5 Guide. More information is available in this News.

The US American Pharmacopoeia USP has informed about its plan to replace the title of General Chapter <41> "Weights and Balances" by "Balances" and also to revise General Chapter <1251> "Weighing on an Analytical Balance". More details about the current proposals regarding the qualification of analytical balances can be found here in the News.

What are the risks of humidity excursions during transportation of products (medicinal products, APIs, intermediates)? A current publication in the USP Pharmacopeial Forum has examined the question. Read more here about the USP article.

In June 2012 the EMA posted a new question in the Q&A part on quality of medicines regarding how to set specifications for genotoxic and potentially genotoxic impurities. Read more.