Joint auditing under two ISO standards: problems to avoid
This article was originally published in Clinica
Streamlining production systems and cutting auditing times and costs are two of the advantages that should result from the international acceptance of the international medical device quality system standard ISO 13485:2003. An additional advantage is derived from the fact that this standard is so closely based on the generic quality system standard, ISO 9001:2000.
You may also be interested in...
Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
Deal snapshot: For $425m up front, the pharma obtains a Phase III recombination fusion protein that shows ability to improve hospitalized patients’ clinical status and reduce risk of death.
Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.