The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.
The U.S. FDA published a draft guidance on the dosage and administration labeling section for certain medicinal products. The guidance is one of several FDA guidance documents addressing labeling for human prescription drugs.
The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.
Fluoropolymers have an extremely high chemical stability. However, this stability also means that once they enter the environment, they can remain there for a very long time and cause environmental damage. The EU plans to restrict or ban perfluorinated and polyfluorinated alkyl substances (PFAS), which include PTFE, for example, in the future. This would have serious consequences for plants in the pharmaceutical industry, for example, where PTFE is used as a material for seals.
Financial and organizational advantages also 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 3: What are the reasons for choosing the particular cloud model (private cloud, community cloud, public cloud)?
There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.
The two pharmacopoeial monographs (2034) and (2619) have recently been revised. Read more about the requirements that manufacturers of APIs need to follow with regard to possible nitrosamine contamination in their products.
In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022. Significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs) are listed and a long list of Data Integrity remedation activies is required.
The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.
Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging? This is one of three new questions answered by the European Medicines Agency (EMA) on its website. The other two questions relate to the activities of brokers with parties outside the EEA.
The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.
The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter to a US company. The FDA states that the firm violated the Drug Supply Chain Security Act (DSCSA). Specifically, the letter concerns a former subsidiary of the company that was a licensed pharmacy and wholesale drug distributor.
If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. We have prepared an overview of the GDP Non-Compliance Reports published in 2022 and the respective reasons for issuing these reports.
In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?
Already in 2018, the ICH had started working on a Guideline entitled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS - Q13". A draft was published in mid-2021. Now ICH has approved the final version.
With ICH Q9 Quality Risk Management becoming effective, risk analyses have become the "magic word" in the GMP environment. But risk analyses do not always help. An example of this can be found in an FDA Warning Letter on the subject of cross-contamination.
In the Pharmacopeial Forum, PF 49(1), a proposal for a revised USP General Chapter <1236> Solubility Measurements was published. Based on comments received, some revisions were made in addition to those proposed in PF 48(2).
Australia´s Therapeutic Goods Administration (TGA), which regulates Medicinal Cannabis in Australia, has put out its latest Compilation regarding the production and import regulations (TGO 93). As of July 2023, all imported medicinal cannabis products released for supply in Australia will have to present evidence to be produced under GMP.