GMP News - Analytical Quality Control

05.12.12

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.

more

14.11.12

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.

more

07.11.12

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.

more

01.10.12

FDA Dissolution Methods Database

FDA aids the pharmaceutical industry in developing generic drug products by providing a database on methods for active drug dissolution testing. The most important functions are described in the FDA document "Frequently Asked Questions". You can obtain more information in this news.

more

19.09.12

Dissolution Testing of new and special Dosage Forms - Updated FIP/AAPS Document

Due to the rapid evolution of new practices and techniques for dissolution/drug release testing, FIP decided to revise the previous position paper from 2003. Get further information.

more

12.09.12

USP Standard for Dissolution Testing withdrawn

USP has withdrawn a standard for the Apparatus 3 Performance Verification Test for dissolution testing as of February 2012. Get more information, also about the background - in this news.

more

22.08.12

Curved Calibration Functions - how to perform the Regression Calculation?

For curved calibration functions there exists some uncertainty how to establish a calibration which is in conformity with DIN/ISO standards. In this news you will be informed about new possibilities for performing the corresponding calculations.

more

22.08.12

FDA Expectations concerning Real Time Release Testing (RTRT)

The FDA has highlighted the importance of Real Time Release Testing (RTRT) in a publication. It explicitly supports the implementation of RTRT approaches in the pharmaceutical industry.  When RTRT is used, it is part of the control strategy and can include some or all of the final critical quality attributes (CQAs). Please click here to obtain more information in this news.

more

22.08.12

New EMA draft on NIRS

The EMA has published the draft for a Guideline on the use of Near Infrared Spectroscopy (NIRS) in January 2012. NIRS is one of the most important technologies in PAT applications. The guideline deals with qualitative and quantitative procedures. You can obtain more information in this news.

more

22.08.12

USP Article about new USP NIR System Suitability Reference Standard

In an article of the USP Pharmacopeial Forum, the authors give reasons why the continued use of the USP NIR System Suitability Reference Standard is recommended. More about the USP article and the verification of wavelengths of NIRS systems by calibration standards can be found here.

more

22.08.12

New EMA Guideline on Real Time Release Testing

The concept of parametric release has been primarily used for the sterility testing of products terminally sterilised. Now, the new EMA Guideline will extend this alternative release strategy - Real Time Release Testing - to all types of APIs and finished products testing. Read more here in the News.

more

25.07.12

How to set Specifications for Genotoxic, Metallic Impurities and Residual Solvents in APIs?

The EMA has recently extended its Questions and Answers collection with three statements regarding the setting of drug substance specifications for potentially genotoxic, metallic impurities, and solvent residues. More details here.

more

06.06.12

Important Notice from the EDQM to CEP Holders - Warning of Fraudulent Invoices

In a press release from 21 May 2012, the EDQM warned CEPs holders (Certificates of Suitability) of fraudulent invoices. Read more in this News.

more

30.05.12

Current State of Harmonisation (EP/USP/JP)

According to a notice from the EDQM with regard to a meeting of the Pharmacopoeial Discussion Group (PDG) 28 of the 35 General Chapters and 41 of the 61 monographs on excipients are currently harmonised. You will find more about the latest status relative to the PDG working group in this news. The strategies for an efficient management of the different pharmacopoeial requirements (EP, USP, JP) are also the topic at an international Pharmacopoeia conference in Prague.

more

30.05.12

Incorrect Handling of OOS Results found in 10 FDA Warning Letters in 2011

In reviewing FDA's Warning Letters from the calendar year 2011, it has been found that 10 Warning Letters contained complaints about GMP/FDA compliant handling of OOS results. As a matter of fact, the handling of OOS results remains one of the most critical aspects during an FDA inspection. The most important citations from the Warning Letters can be found in this News.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics