GMP News - Analytical Quality Control

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.

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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USP Standard for Dissolution Testing withdrawn

USP has withdrawn a standard for the Apparatus 3 Performance Verification Test for dissolution testing as of February 2012.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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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23.05.12

OOS Results - Very helpful Q&As published on the MHRA Website

The MHRA has published a presentation on its website about the expectations of the authority regarding the handling of OOS results in pharmaceutical laboratories. Among other things, the website provides 20 questions and answers on the OOS topic. At ECA's OOS Forum in Prague in June, Di Morris from the MHRA will present the correct handling of OOS results in the microbiological laboratory. Find out more.

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23.05.12

New Developments at EP, USP an JP - Divergent Compendial Methods and Harmonisation

Pharmacopoeias are defining normative standards to be followed by the pharmaceutical industry. Actually some of the most important general chapters are being revised or updated and some texts will be established as completely new chapters. In addition harmonisation is another important issue. Please read more here.

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16.05.12

New USP Chapter on Method Transfer effective

The method transfer is a documented process which establishes the evidence that a laboratory is qualified to use an analytical method which has been elaborated in another laboratory. Hereby the evidence must be brought that the laboratory has the knowledge and the ability to perform the analytical method as intended. The USP 35 now includes a new General Chapter <1224>. Read more here in the News.

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16.05.12

Interesting USP Validation Documents - Available Online free of Charge!

The USP has put new standards online and for free in the Medicines Compendium. In doing so, the USP wants to contribute to improve the quality of starting materials and medicinal products worldwide. This includes monographs for APIs and medicinal products, General Chapters and even data on the validation of the analytical methods used. Read more in this News.

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