ARDRA fingerprinting could not distinguish between genomic species of Acinetobacter, even at a low cut-off level (Koeleman et al. 2005) were identified using the ARDRA technique, though their identity was not confirmed by sequencing. Mycoplasma species isolated from cats (Criado-Fornelio et al.
It is thus suggested that the prediction power of ARDRA clusters in identifying clone phylogeny be regarded with caution.Īttempts to use ARDRA to identify species within particular genera have only been partially successful. Although ARDRA-based clusters separated clones into different genera, these phylogenetic clusters did not overlap with trees constructed according to sequence alignment, calling into question the intra-genus ARDRA-based phylogeny. ARDRA was performed in silico on 48,759 sequences from the Ribosomal Database Project, and it was found that the fragmentation profiles were not necessarily unique for each sequence in the database, resulting in different species sharing fragmentation profiles. Here we used ARDRA as a model to examine the capacity of restriction-based techniques for clone identification, and the possibility of deriving phylogenetic information from ARDRA-based dendrograms. Protected documents are for PIC/S Members-only and require a login.Amplified ribosomal DNA restriction analysis (ARDRA) and restriction fragment length polymorphism were originally used for strain typing and for screening clone libraries to identify phylogenetic clusters within a microbial community. As a matter of fact, PIC/S has been instrumental in elaborating a first draft for the ICH Q7A Guide on APIs, which was finalised by ICH in 2000 and then adopted by PIC/S.Īll PIC/S documents publically available are listed below and appear in alphabetical order. In addition to the GMP Guide, PIC/S has also been a pioneer in developing a number of guidelines and guidance documents such as the Site Master File, the Recommendation on Quality System Requirements for Pharmaceutical Inspectorates and the first Guideline for the Manufacture of Active Pharmaceutical Ingredients.
Since that time, the EU and the PIC/S GMP Guides have been developed in parallel (both Guides are practically identical).
In 1989, the EU adopted its own GMP Guide, which - in terms of GMP requirements - is equivalent to the PIC/S GMP Guide. biologicals) and to adapt to scientific and industrial technology (e.g. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringent manufacturing and health requirements, to cover new areas (e.g. The main instrument for harmonisation has been the PIC/S GMP Guide. Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents.
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