GMP News - Analytical Quality Control


USP proposes revision of general chapter <1225> Validation of compendial procedures: Adding a section on Life Cycle Management

The USP proposed a revision of chapter <1225> in PF 42(2) (March-April 2016). The proposal includes addition of a section on "Life Cycle Management of Analytical Procedures". Read more about the proposed revision of general chapter <1225> "Validation of compendial procedures".



FDA Guideline on Dissolution Testing

The FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised. Read on to get more information about FDA's Guideline on Dissolution Testing.



ICH publishes Training Modules on "ICH Q3D - Elemental Impurities"

The ICH has recently published 7 training modules on the ICH Q3D Guideline "Elemental Impurities". Read more about which essential topics related to metallic impurities limits, risk assessment, control strategies are detailed in those modules.



FDA Warning Letter addressed to a Manufacturer of Medicinal Products in Hong Kong

The compliance situation at a manufacturer of medicinal products in Hong Kong was so bad that the FDA issued an import alert for this company. Find out more about the Chan Yat Hing Medicine Factory Warning Letter issued by the FDA.



Revised Ph. Eur. Chapter on Raman Spectroscopy introducing PAT

The revised General Ph. Eur. Chapter on Raman Spectroscopy (2.2.48) comes into operation on April 1, 2016. The Chapter now includes hand-held devices and adaption to PAT purposes. Find out more about the revised  Ph. Eur. Raman Spectroscopy chapter.



Current FDA Warning Letter for Manufacturer Cadila in India

As part of its inspections, the FDA nowadays always examines the integrity of data. This can clearly be seen in the recent Warning Letter from December 2015. Besides, the letter focuses on the inappropriate handling of OOS results. Read more about the current FDA Warning Letter on Data Integrity. 



Texts adopted by the Ph. Eur. Commission

The Ph. Eur. Commission adopts 28 new monographs during its 153rd session held on 17-18 November 2015 in Strasbourg. The Texts will be published in the 9th Edition of the Ph. Eur. and shall become effective on 1st January 2017. Find out more about the new and revised texts adopted by the Ph. Eur. Commission.



Draft Annex 17: Real Time Release Testing, Revision 1

A revised version of Annex 17 is in preparation. On 15 September 2015, a consultation was launched on a draft revised Annex 17: Real Time release Testing. The document is for consultation until 11 December 2015. Read more about the consultation on the EU GMP Guidelines, draft revised Annex 17 on the Real Time Release Testing.




Consequences of the new MHRA Guideline for Excel

In March 2015, the British authority MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). These requirements apply to all electronically stored data - regardless of the technology used for data saved in MS Excel. Learn more about the relevance of the MHRA Guideline for MS Excel.



In-process revision to USP <1058> - Analytical Instrument Qualification (AIQ)

An in-process revision to USP <1058> on Analytical Instrument Qualification (AIQ) was issued for public comment in the May-June 2015 issue of Pharmacopoeial Forum. Find out more about the changed version of USP General Chapter <1058> - Analytical Instrument Qualification. 



Another FDA Warning Letter with Focus on "Data Integrity"

The US FDA has a new focus of their inspections: the review to the integrity of data. A recent Warning Letter from July 2015 shows again a clear focus on the issue of data integrity. Please find more information in the Current FDA Warning Letter regarding Data Integrity.



New USP proposal for updating identity checks in U.S. Pharmacopeia

New proposals for checking identities have been introduced in a USP article and published in the Pharmacopeial Forum, together with the planned chapter revision <191>. In future, the checks will be much more flexible. Find out more about the planned Update of the Identity Check in the U.S. Pharmacopoeia.



FDA Guidance on analytical procedures and methods validation published

The FDA Draft Guidance on Methods Validation has recently been revised and finalised. Please read about some important points required by this Guidance regarding validation of analytical test procedures.



HMPC Q&A Document on Herbal Medicines revised

The actual questions and answers on the quality of herbal medicines and traditional herbal medicines were revised in January 2015 within the fifth revision. The question on the testing with respect to benzene impurities was newly added. Find out more about the HMPC Q&A Document.



New ICH Q3D Training Materials available

The International Conference on Harmonisation (ICH) wants to facilitate the implementation of their Guidelines and other documents through issuing new training materials. Just recently the ICH has updated their website with new materials on Q3D.


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