GMP News - Analytical Quality Control

15.02.12

ECA Analytical Quality Control Working Group - Final OOS SOP

ECA's SOP Laboratory Data Management; Out of Expectation (OOE), Out of Trend (OOT) and Out of Specification (OOS) Results will be presented at the OOS Forum in Prague on 19-20 June 2012. Experts from industry and regulatory authorities will discuss this SOP and will also present alternative approaches for the handling of OOS-Results. Further details can be found here.

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08.02.12

New EMA Guideline on Specifications for Herbal Medicinal Products

The EMA guideline on specifications for herbal substances, preparations and medicinal products has been updated. Version 02 was published at the end of September 2011 by the EMA. Further information and the link to the document can be found here in the News.

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25.01.12

Short-term Revision of USP Chapter on Dissolution Testing

A short-term revision of the USP Chapter on Dissolution Testing has been necessary as the reference standard tablets mentioned in it are no longer available. Read more here.

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07.12.11

Archiving of Chromatograms: FDA provides important Clarification

For the FDA, printed chromatograms alone do not satisfy GMP-compliant documentation of raw data. This statement has been issued in an FDA Question und Answer document. Read the complete News here.

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30.11.11

USP publishes First Ten Quality Standards in New Medicines Compendium

On November 28, 2011 the United States Pharmacopeial Convention (USP) published the first ten standards for the USP Medicines Compendium (MC). Click here to read more

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21.09.11

ICH Q4B - Annex 7(R2) on "Dissolution Testing" becomes binding in the USA too

The second revision of the ICH document on Dissolution Testing for the comparability of pharmacopoeial texts in Europe, USA and Japan was published in June 2011 by the FDA. One of the aims of this guideline is to avoid redundant investigations by the pharmaceutical industry. Read more here.

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14.09.11

New: Revised USP Monographs of Spectroscopic Methods

Six updated chapters about AAS, IR and UV-Vis were published in the Pharmacopeial Forum from September 2011. The USP will replace the existing Chapter <851> with this group of topics. You will find more details here.

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07.09.11

Revision of USP 231 "Test for metal Catalysts" - what will change?

Because of recent toxicological data, the detection and quantification of metal impurities in medicinal products and food supplements is of considerable importance. The methods described in the USP don't meet the current state of technology and are being revised. What changes can be expected in the new USP chapters <232> and <233> and what will be the consequences for the QC laboratories can be read here.

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07.09.11

USP and FDA strengthen Collaboration

To strengthen their collaboration, USP and FDA signed a 3-year agreement. In concrete terms, 40 chemical reference standards should be jointly controlled by them. Read more here.

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10.08.11

ECA Analytical Quality Control Working Group - OOS SOP Development

The generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results is the first project of a new ECA Analytical QC Working Group. In a first step the OOS Flow Chart had to be established, the second step comprised the development of an OOS SOP. Please read here for more details.

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10.08.11

New WHO Document on Transfer of Processes with detailed Guidelines for Analytical Method Transfer

The new WHO document on technology transfer also provides interesting and detailed indication for analytical method transfer. Click here to read the full news and to access the WHO document.

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08.08.11

WHO in charge of Qualifying QC Laboratories for the UN

Private and governmental quality control laboratories may undergo a standardised quality assessment by the WHO to prove their compliance with the WHO requirements and therefore to be in a position to take over contracts for the UN. Read more here.

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27.07.11

New FDA Guidance on Dosage Delivery Devices (measuring Spoons, Droppers, etc.)

According to the FDA, wrong or insufficient labeling on dosage delivery devices for liquid drugs endangers the drug safety because this can lead to accidental overdoses. Read more in this News.

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08.06.11

Modernisation of USP Monographs

The list of monographs in need of revision was updated on 26 April 2011. Read here which monographs the USP plans to modernise.

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25.05.11

The Challenges of Ensuring Laboratory Data Integrity

The integrity of laboratory data generated in analytical labs needs to be ensured for paper systems, for paper and  electronic systems (hybrid), as well as for electronic systems. The problem is that "raw data" has not been defined in the new EU GMP Chapter 4. Please find in Dr. Bob McDowall's article how the definition of "raw data" in the GLP regulations can help.  

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