Also in September 2022, the EDQM has prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) and has now published it in the EDQM website newsroom.
The ECA regularly analyses the deficiencies identified in FDA Warning Letters relating to medical devices. Since medical devices can also be part of a combination product of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What do the medical device Warning Letter statistics show for the 2022 fiscal year?
The EDQM has announced the availability of a new document in the Knowledge database concerning the revised general chapter 2.2.46. Chromatographic separation techniques. It provides a comparison of the requirements included in the 10th Edition vs. the 11th Edition of the European Pharmacopoeia.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.
In August 2022, the National Agency for Medicines and Medical Devices of Romania added a new GDP Non-Compliance Report to the EudraGMDP database. The company in question "failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities)".
The EMA has published a list of the main therapeutic groups in order to avoid shortages of medicinal products in the case of a public health emergency and thus to ensure the supply of critical medicinal products. Another EMA document defines the methodology for establishing and maintaining this list and further lists of critical medicinal products.
Deficiencies in the quality system repeatedly lead to so-called GPD Non-Compliance Reports. But what are the requirements for the quality system in the GDP environment, and which processes must be in place within the company?
Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?
Since the beginning of September 2022, the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" has been published for comments on the USP Pharmacopeial Forum website. Comments and observations on this draft can be submitted until 30 November 2022.
To keep a pharmaceutical water system in the qualified state, a suitable maintenance strategy with appropriate maintenance intervals is required. This is demanded by GMP and also makes sense from an operational point of view. Maintenance intervals are already determined in the design phase based on the criticality of the individual components and are specified and controlled in the subsequent commissioning and qualification steps. But which procedures and specifications make sense for the maintenance of a pharmaceutical water system?
The FDA released a technical specifications document to assist interested parties in electronically submitting ICSRs to the agency. Read more about FDA´s regional ICH E2B (R3) Implementation Guideline.
The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.
The final version of Ph. Eur. 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders has been published in the European Pharmacopoeia (Ph. Eur.) 11.1. The supplement is now available and will become applicable as of 1 April 2023.