The U.S. Food and Drug Administration (FDA) issued a discussion paper on "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." In particular, the FDA wants to receive feedback on the key areas in the context of AI/ML, including Good Machine Learning Practice (GMLP).
The U.S. Food and Drug Administration (FDA) has published a Form 483. During an inspection at an Indian drug manufacturing side, several CGMP violations were documented. These concerns, among others, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, where results were invalidated by retesting the batches without a scientifically justified root cause.
In March 2023, the ECA offered the Live Online Training "How to register APIs in Brazil". With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by the speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, are listed in the following.
Good Manufacturing Practice is referred to as GMP in the EU, in almost all PIC/S countries and at WHO. The FDA, however, refers to it as CGMP. But what exactly is behind it? The FDA has published a paper on this.
If you are a non-EU based company exporting drug products into the EU, it is essential to understand the role of a QP. It's also helpful to understand all other EU-GMP requirements to be better prepared for inspections.
The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website.
In October 2022 you could already find out in a news that the FDA does not accept the manufacture of medicinal products on equipment that is also used to manufacture non-pharmaceutical products. But what are the consequences if the FDA does discover such manufacturing?
Since the beginning of May 2023, the chapter <2> Oral "Drug Products - Product Quality Tests", which is part of the heading "General Tests & Assays", has been published for comments on the website of the Pharmacopeial Forum of the USP. Comments and remarks on this draft, which is based on the previous version from August 2020, can be submitted until 31 July 2023.
The EMA has published a Guidance for Industry on "Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact". It provides ten recommendations for various stakeholders.
The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.
The European Medicines Agency (EMA) has published the annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022. An updated work plan 2021-2023 has also been issued.
Just recently, you could read about the Good Manufacturing and Distribution Practice Symposia 2023, organized by the Medicines and Healthcare products Regulatory Agency (MHRA) on 21 and 22 February 2023. A summary of the GDP part was now published on the MHRA Inspectorate blog.
After the competent authority of Czechia (State Institute for Drug Control) had just recently added four GDP Non-Compliance Reports to the EudraGMDP database, another one was added at the end of April 2023.
More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 2 here.
According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG). What changes may result?
In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The new draft represents the Pharmacopeial Discussion Group (PDG) harmonized document.
In the Pharmacopeial Forum, PF 49(3), proposals of revised USP General Chapters <782> Vibrational Circular Dichroism Spectroscopy and <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice were published for comments.
Due to deficiencies found in an FDA inspection, a US pharmaceutical manufacturer has now received a Warning Letter. Among other things, a dead leg in the pharmaceutical water system is listed as a deficiency.
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 12: Will it be sufficient to send a check list for the assessment of the CSP - for instance Amazon and Microsoft?
The USP previously announced to elaborate a chapter on quality considerations for Cannabis. Now the draft chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research has been published in PF 49.3. Comments can be sent to the USP until end of July.