Industry News
Join the MWA Team at these upcoming industry events:
PDA West Coast Chapter- 4th Annual Cell and Gene Therapies Meeting; March 23, 2023
Attending: Cell and Gene Therapies
PDA Annual Meeting Conference; April 3-5, 2023 – New Orleans, LA
Attending: 2023 PDA Annual Meeting
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry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FDA Announces Availability of Portal and draft Guidance on Reporting Amount of Listed Drugs and Biological Products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FDA Issues New Draft Guidance on Sponsor Responsibilities for Safety Reporting Requirements and Safety Assessment in Certain Research Studies
The U.S. Food and Drug Administration has issued the draft guidance for industry, Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability (BA)/Bioequivalence Studies (BE).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...
Inspection of Biotechnological Manufacturers: PIC/S AiM Updated
In January 2021, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire. The aide memoires were drafted with the aim of facilitating the effective planning and conduct of GMP...
Updated Guidance on the Management of Clinical Trials during COVID-19
The European Medicines Agency (EMA), the Heads of Medicines Agency (HMA) and the European Commission (EC) have published a joint guidance on the management of clinical trials during the coronavirus pandemic. The guidance has been revised in February (Version 4) to...
Conduct of Clinical Trials During COVID-19: Guidance for Industry, Investigators, and Institutional Review Boards
FDA has provided general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. This...