Industry News
Join the MWA Team at these upcoming industry events:
PDA Annual Meeting Conference; April 3-5, 2023 – New Orleans, LA
Attending: 2023 PDA Annual Meeting
FDA Proposed Rule: Quality System Regulation Amendment
On February 23, 2022 the FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) to incorporate the international standard specific for...
Center for Devices and Radiological Health (CDRH) Issues 2022-2025 Strategic Priorities
FDA’s Center for Devices and Radiological Health (CDRH) announced its 2022-2025 Strategic Priorities. The center established clear goals and measures of success for the overarching device program and each strategic priority. CDRH’s measures of success will show the...
Remote Auditing: Three Keys to Success
This article was originally published in March 2021. Remote audits will continue to be the norm for 2022. While not always ideal, remote audits can be conducted effectively under the proper circumstances. This article can also be read on MasterControl’s GxP Lifeline....
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry
FROM THE INTRODUCTION: Visible particulates in injectable products can jeopardize patient safety. This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development,...
FDA Announces Availability of Portal and draft Guidance on Reporting Amount of Listed Drugs and Biological Products
FDA has announced the new use of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for...
FDA Issues New Draft Guidance on Sponsor Responsibilities for Safety Reporting Requirements and Safety Assessment in Certain Research Studies
The U.S. Food and Drug Administration has issued the draft guidance for industry, Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability (BA)/Bioequivalence Studies (BE). This guidance merges content from the final...
New Version of WHO Guidelines on Process Transfer Published as a Draft
(ECA Academy, 5/12/21): The World Health Organization (WHO) has recently published a new version of its guidelines on the transfer of technology as a draft. The draft originally dates back to 2020 and was presented at the 65th meeting of the Expert Committee on...
FDA Guidance: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency
On April 21, 2021, The US Food and Drug Administration (FDA) issued guidance detailing its approach to remote interactive evaluations of drug and biomedical research facilities during the public health emergency. Teleconferencing, livestreaming video and...
Conducting Remote GxP Audits: Three Keys to Success
This article can also be read on MasterControl’s GxP Lifeline. Introduction: The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on course toward product...
Guidance for industry on MHRA’s expectations for return to UK on-site inspections
Medicines and Healthcare products Regulatory Agency (MHRA) will resume an on-site UK risk-based GxP inspection program beginning March 29, 2021. The MHRA Inspectorate will continue to use a combination of remote and on-site inspection approaches. The MHRA is...