GMP News - Analytical Quality Control


Handling of APIs and Excipients - New Guidelines in Chapter 5 of EU GMP Guide

The new Chapter 5 - Production - of EU GMP Guide deals with many aspects which are relevant for quality assurance and quality control, too - like for example the handling of APIs and excipients, concrete requirements on the acceptance of the certificate of analysis of the supplier as well as the opportunities the new chapter offers regarding reduced sampling and reduced testing. Read more here in the News.



New USP Chapter on Inhalation Drug Products

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.



Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control

The transfer of analytical methods is one of the new requirements in the revised Chapter 6 - "Quality Control" of the EU GMP Guide. The transfer of the test methodology from one laboratory to another has to be described in an written protcol. Please see this news for further information.



Quality Standards on Recovered Solvents in the Manufacture of Herbal Medicinal Products

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.



Laboratory Data Integrity in FDA Warning Letters 2012

Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful inspection for any GMP regulated quality control laboratory. Please find in our News selected key citations regarding Laboratory Data Integrity in FDA Warning Letters from 2012.



New: ICH Q4B - Annex 13 on the Density of Powders

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. 



ECA Analytical Quality Control Working Group - Final OOS SOP

ECA's working group Analytical Quality Control has developed a new general SOP on the handling of OOS results. This SOP was presented at the OOS Forum in Prague, the official launch conference for this SOP, in June 2012. At the Forum alternative approaches were discussed by representatives of industry and authority. The final ECA SOP came into force in August 2012. Get more information.



New GAMP Guide for Laboratory Computerized Systems

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.



New EMA Guideline for Products with modified Active Substance Release

In many pharmaceutical dosage forms the release of the active substance changes in comparison with the conventional release. For the quality of these products the EMA issued a draft guideline. To find out more about the EMA requirements with regard to the quality of products with modified API release please read this news.



Analytical Balances: New USP Proposals on Qualification

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.



Significant Guidelines regarding Veterinary Medicinal Products

Five new documents have been published by the EMA for manufacturers of veterinary medicinal products, including the VICH Guideline Draft on Statistical Evaluation of Stability Data. Read more here about these documents published for veterinary use.



New USP Publication: Monitoring Humidity during Transportation?

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.



USP Postpones the Publication of General Chapters <232> and <233> on Metallic Impurities

The introduction of the USP chapters in metallic impurities originally planned for 1st December 2012 has been postponed. Read more here about USP's reasons for that decision.



New EMA Q&As on Genotoxic Impurities

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.



New EMA Guideline on Specifications for Impurities in Antibiotics

A new EMA Guideline on impurities of APIs manufactured by fermentation with eventual further synthetic steps defines precise requirements with regard to the information that has to be provided on these impurities. Read more here in the News.


GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics