Extraordinary Newsletter n°18/2017
Informativos . 25/07/17
The Resolution of the Collegiate Board of Directors No. 166, which provides for the validation of analytical methods, was published on July 25, 2017 in the Official Gazette.
The resolution is more detailed than the previous one dealing with the subject, but there have been no changes with regard to the work ranges, need to use pharmacopoeia reference standard, although there is some flexibility to justify exceptions.
The resolution clarifies that pharmacopoeia methods need to be checked for adequacy through partial validation and also how the inter-laboratory methodology transfers should be.
The resolution repeals RE No. 899/2003; Item XXXI of Article 1, the sole paragraph of art. 11 and Annex I of Resolution RDC No. 31 of 11 August 2010 and enters into force 180 days after publication, i.e. January 2018.
Validations of analytical methods in accordance with RE 899/2003 will be accepted provided they have been finalized prior to the effective date of the resolution (01/21/2018) and petitions containing them have been filed within 550 calendar days after the validity of the resolution (07/25/2019).