Supplement 11.2 to the European Pharmacopoeia (Ph.Eur.) came into force on 01 July 2023 and contains several updated monographs. These include five updated excipient monographs, which now include the so-called "functionality-related characteristics (FRCs)" section. In total, there are now more than 100 Ph.Eur. Monographs that include this section.
FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The company in question manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers. The list of GMP violations is quite extensive and concerns, among others, QU oversight, handling of out-of-specification (OOS) results, identity testing, and laboratory controls in general.
New in the ECA Members Area: "QA Responsibilities" in the Mirror of Warning Letters
The FDA's Warning Letters contain detailed descriptions of GMP deficiencies and thus provide a useful perspective in the context of preparing for an FDA inspection. In the members' area of the ECA Academy website, topic-focused descriptions of these GMP deficiencies are available, e.g. a compilation on GMP violations in the area of quality assurance.
As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.
EDQM: Policy for CEP Applications published for Comments
In June, the draft Certification Policy Document PA/PH/CEP(04) 1, 6R "Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use" was published on the EDQM website for comments. Comments and remarks on this draft can be submitted until 15 September 2023.
COVID-19 Flexibilities also to be terminated in the GMP/GDP Environment
The EU is phasing out the extraordinary regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This includes regulatory procedures, manufacturing and importation of APIs and finished products and other requirements.
EU-GMP: Is remote QP Batch Certification/Confirmation allowed?
The EMA has published new questions and answers on remote batch certification/ confirmation by the Qualified Person (QP). When allowed by the competent authority, clear expectations are defined.
In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.
FDA now also assesses Countries and Regions as a Risk Factor
The FDA has updated one of its internal manuals to add a risk factor for facilities in countries where there has been an increase in violations. This is nothing more than a risk factor for a region or an entire country.
Quality Culture in the Pharmaceutical Industry: Benefits and Challenges
The pharmaceutical industry's adoption of Quality Culture is transforming the way organisations approach quality management. Although challenges exist in fostering a culture of quality, the benefits outweigh the obstacles.
Packaging of Solid Dosage Forms: Warning Letter in the USA
Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.
Northern Ireland: EU Regulation with specific Rules published
An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.
The European Medicines Agency (EMA) has published on its website the detailed minutes of the Herbal Medicinal Products Committee (HMPC) meeting from 13-15 March 2023. In the meeting, the HMPC discussed some issues known to cause difficulties in procedures and ideally to be addressed during the current GACP revision.
News on the Windsor Framework for Medicines Supply in Northern Ireland
The MHRA has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. One key issue concerns the packaging and labelling of medicinal products.
Appearance as a Release Test? This is not the Way to get through an Inspection
The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.