877.717.7997

FlightBlog

Category Archives: GLP

Share on Google+ May 8, 2017

0 Comments

An Update From The APS In-Vitro Testing Laboratory

Category : APS Service Offerings, FDA, GLP, In-vitro testing, Our Laboratories

The In-vitro Testing Laboratory has had a busy start to 2017. Most recently, we presented at the Society of Toxicology (SOT) conference on the improvements of the multiple hemocompatibility tests, including the In-vitro Blood Loop Assay and Platelet/Leukocyte Count Assay. Collaboration with the FDA is ongoing for the In-vitro Blood Loop assay – we have submitted our methods and protocol

View Post

Tags : , , , ,

Share on Google+ October 18, 2016

0 Comments

FDA Issues Notice of Proposed Rulemaking Regarding 21 CFR Part 58, Good Laboratory Practice (GLP).

Category : FDA, GLP, In-vivo Testing

The proposed changes would affect all participants in GLP trials:  Sponsors, Testing Facilities and supporting laboratory services.  We encourage all affected parties to review and comment on the proposed changes.  The public comment period for the proposed changes closes November 22, 2016.  Details on the proposed changes and how to comment are available on the Federal Register website:  https://www.federalregister.gov/documents/2016/08/24/2016-19875/good-laboratory-practice-for-nonclinical-laboratory-studies APS

View Post

Share on Google+ October 16, 2015

0 Comments

New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

Category : FDA, GLP, In-vivo Testing, Medical Device testing, Study Management, Uncategorized

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.  The purpose of this document is, once final, to supercede FDA’s current Guidance entitled General Considerations for Animal Studies for Cardiovascular Devices, which was issued on July 29, 2010. The Big Picture

View Post

Share on Google+ May 8, 2014

0 Comments

APS’ Continued Commitment to quality

Category : FDA, GLP, Medical Device testing, Thrombogenicity, Uncategorized

APS Receives FDA Clean Bill of Health APS is committed to quality. In March 2014, APS was inspected by the FDA for compliance to 21 CFR Part 58, FDA Good Laboratory Practice. During this multi-day inspection, the FDA thoroughly reviewed APS’ quality systems. The outcome of this audit demonstrated that APS was in full compliance with no deficiencies being identified.

View Post