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API Testing is also relevant for the FDA - Warning letter to Indian Manufacturer

Access Letter Here The system was poorly designed, e.g. with ‘blind spots’ and lack of continuous circulation, increasing the risk of biofilm formation. Insufficient monitoring was carried out to ensure that the system was functioning properly and was suitable for production. FDA requirements: Validation of the system, including design, maintenance and continuous monitoring. Implementation of programmes to monitor and record microbiological and chemical parameters. Implementation of a risk assessment plan to evaluate the impact of system failures on the quality of drugs distributed in the US. This will include customer notifications and recalls as appropriate. General measures: The FDA requires the company to submit comprehensive corrective actions and timelines. These include Detailed process validation programmes (PPQ) for active ingredients and finished drug products. Systematic identification and control of process variability. Monitoring and qualification of production facilities ...
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European Shortages Monitoring Platform (ESMP) goes live

The European Medicines Agency EMA announced that the European Shortages Monitoring Platform (ESMP) started with the full scope of functionalities on 29 January 2025 (which is ahead of the pre-defined deadline on the 2nd of February). All Marketing Authorisation Holders MAHs are obliged now to only use the platform to report data on medicine shortages and availability issues. In addition to the routine shortage reporting by MAHs of centrally authorised products (CAPs), launched in November 2024, the full scope of functionalities of the ESMP is now available for crisis and MSSG-led preparedness reporting, for both MAHs and national competent authorities (NCAs). EMA collects data via the platform from national competent authorities (NCAs) and marketing authorisation holders (MAHs).MAHs and NCAs will be able to use these functionalities in the event of a public health emergency, major event, or MSSG-led preparedness activity. The platform enables EMA to monitor the supply, demand and avail...
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ANVISA recognises CEPs

At the beginning of December, a news in the EDQM website newsroom informed that the Brazilian health authority ANVISA (Agência Nacional de Vigilância Sanitária) has started to recognise evaluation reports and documents from other authorities as part of its assessments. This includes, for example, the CEP of the EDQM, which can now be used when applying for the 'Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA)' and can therefore provide support when applying for medicinal products in Brazil. Other authorities whose evaluations are now recognised are listed below: European Medicines Agency (EMA)  Health Canada  World Health Organisation (WHO)  Swissmedic  UK Medicines and Healthcare products Regulatory Agency (MHRA)  US Food and Drug Administration (FDA)  Australian Therapeutic Goods Administration (TGA)
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Elemental Impurities: Harmonized chapter finalized

In late November 2024, it was reported on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) that the new harmonized chapter "Elemental Impurities (G-07)" of the "Pharmacopoeial Discussion Group (PDG)" had been signed in June 2024. The PDG consists of representatives from the European Pharmacopoeia (Ph. Eur.), the Indian Pharmacopoeia Commission (IPC), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP). In particular, the harmonization focused on the implementation of the updated requirements of the ICH Q3D guideline and the harmonization of analytical procedures. Special focus was placed on the following three points: Sample preparation Examples of suitable methods and detection techniques Requirements for the validation of procedures The new harmonized chapter "Elemental Impurities (G-07)" will be published in the regional pharmacopoeias according to the following timelines: Ph. Eur: July 20...
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FDA 483s due to Deficiencies in the Stability Program: Evaluation of Fiscal Year 2024

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the FDA's homepage in the subsection on "Inspection Observations". These spreadsheets represent the area of regulation and the number of times it was cited as an observation on a Form FDA 483. Stability studies of pharmaceuticals are a well-established discipline and, of course, an important regulatory requirement. Nevertheless, as highlighted in previous articles, deficiencies in the stability program have been frequently cited in numerous FDA 483s over recent years. The FDA has now published the data for the fiscal year 2024 (October 2023 – September 2024). As in previous years, we have again performed an evaluation with regard to deficiencies in the stability program. Evaluation In the area of "Drugs", the following number of reports have been issue...
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How to keep Analytical Systems Current and Compliant

 25 November 2024, Technology Networks published a new article titled "The Museum of Analytical Antiquities," authored by Dr. Bob McDowall, a member of the ECA Analytical Quality Control Group (AQCG) Advisory Board, and Paul Smith. The article begins with a critical observation: Many laboratories have "working analytical systems purchased back in the mists of time but have obsolete operating systems and/or instrument applications that have not been updated since initial qualification and validation." This reluctance to update stems from the misconception that revalidation is a costly and cumbersome process. Consequently, laboratories avoid software upgrades, leading to potential cybersecurity vulnerabilities and compliance issues. Unlike physical instruments, software doesn't degrade over time. However, it requires regular updates to address, for example application enhancements, error and security fixes or outdated software. For instance, Microsoft’s planned di...
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Pilot Report on the Electronic Product Information (ePI)

Experience gained from creation of Electronic Product Information (ePI) during a pilot has recently been published in form of a report. The report outlines the outcomes of the pilot and derives learnings and recommendations that will inform the next steps towards introduction of ePI for EU medicines. Background The pilot, which involved EMA and the national authorities of Denmark (DKMA), Netherlands (MEB), Spain (AEMPS), and Sweden (MPA), together with industry, resulted in the publication of 23 ePIs from real regulatory procedures, of both centrally and nationally authorized medicines. The ePIs can be viewed at the Product Lifecycle Management (PLM) Portal. The PI of a medicine includes its summary of product characteristics (SmPC), the labelling and the package leaflet (PL). These documents accompany every medicine authorized in the EU and explain how they should be prescribed and used. They can be found, often as a PDF document, on the websites of EU regulators, with a printed PL us...
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Constant reminders in Pharmaceutical Quality System

Subscribe here for Regular Updates Article written using AI technology  What is constant reminder A **constant reminder** refers to something that consistently keeps a particular idea, event, or feeling in someone's mind. This can be a physical object, like a wedding ring symbolizing commitment, or an ongoing situation that evokes specific thoughts or emotions. The term emphasizes the persistent nature of the reminder, making it an unceasing prompt to recall important aspects of life or experiences Inl what situations constant reminders are helpful ? Health Management : They help individuals remember to take medications or attend medical appointments, improving adherence to health regimens Goal Achievemen t: Reminders can keep personal or professional goals in focus, motivating individuals to stay on track with their objectives Daily Routines : They assist in establishing beneficial habits, such as exercising or maintaining a balanced diet, by prompting necessary actions at specifi...
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Two new PICS Documents on Remote Assessments published

Subscribe for Regular Updates Summary   PIC/S has published two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment. The Guidance document is intended to provide guidance on the approach and use of remote assessments including a hybrid inspection as inspection tools to establish consistency amongst Inspectorates. It discusses the logistics for conducting remote assessments, including necessary technical aspects. PIC/S defines three types of remote assessments which vary depending on the level of interaction: Summary Fully Interactive Remote Assessment Partially Interactive Remote Assessment Desktop Assessment and one combination type "Hybrid Inspection". The Aide-Memoire document utilises best practices for performing an interactive remote assessment, including hybrid inspections to assist GMP in...
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Batch Uniformity and Drug Product Integrity / Advanced Manufacturing Technologies US FDA

In early January 2025, the U.S. Food and Drug Administration (FDA) announced the availability of two new documents. Considerations for Complying with 21 CFR 211.110 The FDA explains that "this guidance, when finalized, will describe considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. It also discusses how manufacturers can incorporate process models into commercial manufacturing control strategies." The seven-page document opens with a concise introduction. The guidance is applicable to the manufacture of human drug products, including biological products, as well as animal drug products. However, it does not cover the manufacture of active ingredients. The background chapter sets a link to the use of advanced manufacturing and the use of process models as a part of com...
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