GMP News - Analytical Quality Control

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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09.05.12

New GAMP Good Practice Guide for Risk-Based Approach to GxP Compliant Laboratory Computerised Systems: Due for Publication in June

GAMP is going to update the Laboratory Good Practice Guide. The main objective of the second edition is to align it with the principles in GAMP 5.  One outcome of the new edition is that the seven categories have been discontinued and replaced by the GAMP 5 software categories. The new Laboratory GPG "Risk-Based Approach to GxP Compliant Laboratory Computerised Systems" has gone to press and is scheduled for publication in June. Read more in the news.

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25.04.12

Maintaining Laboratory Computer Validation - How to Conduct Periodic Reviews?

According to the new version of EU GMP Annex 11 it is now a regulatory requirement to conduct periodic computerised systems evaluations. This is currently best practice in the GAMP Good Practice Guide for Maintaining Validation which already contains an appendix for conducting a periodic review. Read more here.

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04.04.12

Significant Changes in HPLC System Suitability: New USP Provisions Planned

So far, chromatographic adjustments haven't been recommended by the USP for the use of gradients in the mobile phase for system suitability tests. In a revised draft for General Chapter <621>, major changes have been proposed in the Pharmacopeial Forum. Read more here.

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21.03.12

Data Integrity Problems as key Issue for Ranbaxy's Consent Decree

On behalf of the US FDA the Department of Justice has filed a Consent Decree of permanent injunction against the generic drug manufacturer Ranbaxy. The manufacturer agreed to remedy GMP deviations and to correct data integrity issues at several plants in India and in the US. Get more information here.

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07.03.12

How to Integrate Analytical Instrument Qualification and Computerised System Validation?

In the January - February issue of USP'S Pharmacopeial (PF) a stimulus to the revision process was published for USP <1058> on Analytical Instrument Qualification. The proposal is based around a more detailed risk assessment for all apparatus, instruments and systems used in a regulated analytical laboratory. This USP General Chapter <1058> is currently under revision. The GAMP GPG for Laboratory Computerised Systems is also under revision and is due to be published in Q2 this year. You will find more information here.

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29.02.12

HPLC in FDA Warning Letters

Which FDA inspections between 2009 and 2011 focused on the use of high performance liquid chromatography (HPLC)? You will find this information in a new compilation with the most important FDA findings on the topic of HPLC. More information can be found here.

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29.02.12

Bio Assays - Commentary – First Supplement to USP 35-NF 30

The USP published comments and responses to General Chapter/Section: <1032> Design and Development of Biological Assays. Read more here.

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15.02.12

EMA Guideline on Quality of Herbal Medicinal Products Updated

The EMA guideline on quality of herbal medicinal products has been updated. Version 2 was published at the end of September. The document addresses the differences between medicinal products containing chemically defined APIs and herbal medicinal products and the resulting requirements and problems. Read more here.

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