The UK MHRA has published an "Explainer for Industry" on the Windsor Framework. It explains the main changes and what companies need to do to prepare.
The U.S. Food and Drug Administration (FDA) continues to conduct inspections within the European Union (EU), as highlighted by a recent Warning Letter issued to an Italian pharmaceutical manufacturer. Following the regulatory findings, the company announced a suspension of OTC production for the remainder of 2024.
For human medicinal products, the so-called 'electronic Common Technical Document (eCTD)' is used as the standard for dossier submissions. Updates for Module 1 have now been published on the EMA's eSubmission website.
The European Medicines Agency (EMA) has published a question and answer on the subject of documentation of the traceability of the supply chain of active substances and the medicinal product.
Supplement 11.7 of the European Pharmacopoeia (Ph. Eur.) is now available. All holders of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) are advised to update their specifications and CEPs to comply with the new monograph by 01. April 2025.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 21: Are (GMP) supervisory authorities allowed to inspect CSP? If not, is this planned for the future?
On the GMP Journal website you can find both all single articles issued in the GMP Journals so far as well as the complete issues - freely available to everybody interested. The new issue includes several articles, including one about the ECA Analytical Quality Control Group's new guide on Analytical Instrument Qualification and System Validation.
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Chinese company registered as a manufacturer of over-the-counter (OTC) drug products. This action was based on a review of records that identified deficiencies in the companys quality control unit, laboratory testing for the drug product, and the identity testing of incoming components.
Pharmaceutical Technologys recent publication, authored by Chris Burgess, Chairman of the ECA Analytical Quality Control Group, takes a closer look at the relationships between data governance, integrity, and quality in the context of pharmaceutical analysis. The article aims to provide a structured model for these terms, including their definitions and interrelationships.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 20: What should be the content of a SLA / contract with a XaaS provider?