GMP News - Analytical Quality Control

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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13.04.11

New Limit regarding unspecified Impurities for certain Substances - EDQM Updates respective CEPs

34 monographs of Ph. Eur 7.0 to 7.2 have been revised regarding the limit for unspecified impurities. Read more about the consequences for applicants of new CEPs.

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01.03.11

Specific WHO Requirements for Dissolution Studies to Support Biowaivers

The requirements on dissolution testing and the main focuses of an inspection are at the core of the WHO document "Points to Consider for Inspections of Biowaiver Data". You can read more about this new WHO-Dokument here. 

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24.02.11

"Q3D: Impurities: Guideline for Metal Impurities" - a new ICH Concept Paper

The control of residual solvents and organic impurities in drugs and APIs is "globally" regulated in respective ICH guidelines (resp. for the economic areas Europe, USA and Japan). For metal impurities there is no comparable harmonised document available, though. The ICH initiated the development of a new guideline in order to close this gap. Read more here.

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22.02.11

EMA/HMPC Reflection Paper on Extracts Purification

An EMA/HMPC Reflection Paper on the Level of Purification of Herbal Preparations to be considered as such has been published. Go here for more information. 

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17.02.11

Quality of Herbal Medicinal Products - Current EMA/HMPC Q&A Document

A new EMA/HMPC document presents 26 different Questions and Answers on Quality of herbal medicinal products/traditional herbal medicinal products. Focus is on Testing Stability: 12 Questions and Answers are dedicated to that subject. You will find more information here.

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27.01.11

Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe. Please read more about this development in a very detailed article provided by the IPQ - one of the most important Journals in the GMP and regulatory environment. Click here

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17.02.10

FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed

The final FDA Guidance for Industry on mechanical calibration of dissolution apparatus 1 and 2 was published in January 2010. Compared to the 2007 draft version, the guideline was completely revised; however, the conclusions and the recommended method for mechanical calibration remained unchanged. Read more here.

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