Hi Marcello,
Hope you are doing good!
I just read this article about Brazil GMP Inspections:
Brazil Drops International GMP Inspection Proposal
Latest News Regulatory Update | Posted: 24 January 2013
By Louise Zornoza, RegLink
The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites.
Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution.
Moreover, elements of the earlier proposal are now covered by the recently launched Public Consultation 02/2013 on the conditions for granting Certificates of GMP and Good Distribution Practice (GDP) and Storage.
So does it mean there won't be international inspections to issue BGMP cert to Foreign mfgs?
Appreciate your clarification!
Thanks,
Sreenu
Hope you are doing good!
I just read this article about Brazil GMP Inspections:
Brazil Drops International GMP Inspection Proposal
Latest News Regulatory Update | Posted: 24 January 2013
By Louise Zornoza, RegLink
The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites.
Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution.
Moreover, elements of the earlier proposal are now covered by the recently launched Public Consultation 02/2013 on the conditions for granting Certificates of GMP and Good Distribution Practice (GDP) and Storage.
So does it mean there won't be international inspections to issue BGMP cert to Foreign mfgs?
Appreciate your clarification!
Thanks,
Sreenu