EDQM's Enquiry on the new Draft of a general Chapter on Uniformity of Dosage Units

On 7 March 2011, the European Directorate for the Quality of Medicines and HealthCare (EDQM) started an inquiry on the proposition of a new chapter for the European Pharmacopoeia, number 2.9.47 entitled "Demonstrating of Uniformity of Dosage Units using Large Sample Sizes".

Recent developments in analytical technology have made it possible to determine the content in a large number of dosage units from a batch using non-destructive methods. Process Analytical Technology (PAT) is often the keyword which refers to these measurement techniques.

So far, the Ph.Eur. general chapter 2.9.40 (Uniformity of Dosage Units) has given few details and has always considered small samples (n = 30).

The new draft of the proposed chapter 2.9.47. aims to basically enable work with larger samples and to determine other acceptance criteria.

The proposed draft distinguishes parametric and non-parametric aspects.

The annex to the draft contains a very interesting scientific publication which highlights the backgrounds for the proposed chapter.

The main concern about the present general chapter 2.9.40. is as follows: when measuring many samples, no result outer the current valid limits is allowed. In the new draft, a small number of unities with bigger deviations may be allowed when a large number of samples are measured.

Since the existing chapter 2.9.40. has already passed through the harmonisation process of the Pharmacopoeial Discussion Group (PDG), it is suggested that the future chapter 2.9.47 will be published as a separate chapter.

Please go

here to find the enquiry on the new chapter, the draft and the article of Holte and Horvat published on behalf of the PAT Working Group of the European Pharmacopeia.

Comments on the proposed chapter 2.9.47 should be submitted by 30 June 2011 to the EDQM.

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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