Industry News
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...
World Health Organization: Guidance on COVID-19 Vaccine Allocation
The Strategic Advisory Group of Experts on Immunization (SAGE) of the World Health Organization (WHO) has released two key documents to help guide the allocation and prioritization of populations to receive COVID-19 vaccines. As safe and effective vaccines for...
FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
On October 15, 2020, U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s...
Draft Guidance from FDA: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry
New guidance from FDA reflects current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. Cannabis and cannabis-derived compounds that may be used in drug manufacturing...