Hrushikesh Belappurkar’s Post

Manufacturers and suppliers of excipients must be comprehensively qualified by manufacturers of medicinal products. A series of regulatory activities in the last two years and a warning letter issued by the FDA listing significant deviations from current good manufacturing practice (CGMP) for a supplier of a widely used excipient have moved the topic in the focus of regulatory bodies worldwide. As excipients are sometimes used in large quantities in dosage forms and may contain impurities, they can affect the quality of a finished pharmaceutical product. They may also contribute to nitrosamine impurities. The manufacturer of medicinal products must not only ensure that the excipients used comply with the authorised specifications, but must also ensure, as part of the qualification process, that manufacturing is carried out under an appropriate quality management system. Risks in manufacturing and quality control must be assessed and controlled. This is only possible if a number of specifics and, above all, the risks involved in the manufacture of excipients are known. Our experts Dr Buschmann and Dr Handler have comprehensively prepared this topic for you in a series of webinars.   This webinar will be presented in 5 parts to cover the relevant aspects for this emerging and broad topic and discuss basic aspects, the positions and regulations of various authorities, the frequently neglected impact of the diversity of the quality of excipients and a guidance to select the right excipient for your specific purpose. Excipients – GMP and CMC Aspects (course: 10675) For more information and to register to LIVE series in 5 modules, please follow this link:  https://lnkd.in/dgJHaawT Helmut Buschmann Norbert Handler IPEC Europe - European Excipients Association EXCiPACT asbl   #Excipient #WHO #IPEC #FDA #GMP #cGMP #Vendorqualification #MedicinalProducts #qualification

Developing Core Competencies in Pharmaceutical Quality: Completion of GMP Training with API Focus. I have enhanced the draft to adopt a more professional tone and focus on the core competencies gained from the GMP training: "Recently completed a comprehensive GMP training program with a specific emphasis on Active Pharmaceutical Ingredients (APIs). This rigorous coursework has equipped me with a strong foundation in pharmaceutical quality systems, regulatory compliance, and risk management principles. Through in-depth exploration of API manufacturing processes, quality control methodologies, and regulatory frameworks, I have developed a keen understanding of the critical role APIs play in drug product efficacy and safety. Eager to contribute to the pharmaceutical industry by applying this knowledge to ensure product excellence and patient well-being." #GMP #qualityassurance #qualitycontrol #drugdevelopment #API #drugmanufacturing #pharmaceuticalmanufacturing #skillsdevelopment #pharmaeducation

What about DMF and its parts? DMF (= Drug Master File) is one of the important records have to be prepared and retained by companies in order to meet the GMP regulations. DMF is a set of documents or a file which need to be presented to the FDA and contains detailed and confidential information which relates to articles, facilities or processes which have been utilized for the purpose of formulation, processing, packaging and storage of drugs meant for human use. It contains complete information about the active pharmaceutical ingredient (API) and the finished dosage form. The submission of DMF is not required by the FDA regulations. It is submitted to support the various applications filled by the DRA department such as IND, NDA, ANDA, BLA, etc.. The content of DMF consists of two parts: 1. Applicant's part (Open part): comprises nonconfidential information that provides access to the license holder for marketing. 2. Restricted part (Closed part): comprises confidential information which is supplied to the authorities only and contains details about the manufacturing procedures. #Be_Updated #Be_Professional #FIY_RA

Manufacturers and suppliers of excipients must be comprehensively qualified by manufacturers of medicinal products. A series of regulatory activities in the last two years and a warning letter issued by the FDA listing significant deviations from current good manufacturing practice (CGMP) for a supplier of a widely used excipient have moved the topic in the focus of regulatory bodies worldwide. As excipients are sometimes used in large quantities in dosage forms and may contain impurities, they can affect the quality of a finished pharmaceutical product. They may also contribute to nitrosamine impurities. The manufacturer of medicinal products must not only ensure that the excipients used comply with the authorised specifications, but must also ensure, as part of the qualification process, that manufacturing is carried out under an appropriate quality management system. Risks in manufacturing and quality control must be assessed and controlled. This is only possible if a number of specifics and, above all, the risks involved in the manufacture of excipients are known. Our experts Dr Buschmann and Dr Handler have comprehensively prepared this topic for you in a series of webinars.   This webinar will be presented in 5 parts to cover the relevant aspects for this emerging and broad topic and discuss basic aspects, the positions and regulations of various authorities, the frequently neglected impact of the diversity of the quality of excipients and a guidance to select the right excipient for your specific purpose. Excipients – GMP and CMC Aspects (course: 10675) For more information and to register to LIVE series in 5 modules, please follow this link:  https://lnkd.in/d5a7frTP Helmut Buschmann Norbert Handler IPEC Europe - European Excipients Association EXCiPACT asbl   #Excipient #WHO #IPEC #FDA #GMP #cGMP #Vendorqualification #MedicinalProducts #qualification

Supplier Qualification In Pharmaceutical Industry 🟢Manufacturing and procurement of materials or services always has been a challenging situation in any drug manufacturing establishment. The production of drug substances or product is subject to strict good manufacturing practices (GMP) that are designed to ensure their quality, safety and efficacy. The practices ensure that the patients worldwide and at any time can have confidence in the quality, safety and efficacies of the medicaments they are consuming. The country of origin or manufacturing clearly outlines the boundaries in each of them and their region to control the best practices while procurement is done. ⏩️Supplier qualification is the process by which your company will choose the correct supplier/third-party vendor for components/raw materials/services based on your requirements and regulatory protocols. 👉Some useful regulatory guidelines include: ✅️PIC/S Guide to GMP – Part I: Chapter 5 – Production (Starting materials and packaging materials), Chapter 7 – Outsourced Activities ✅️PICS/ Guide to GMP – Part II: Chapter 7 – Materials Management ✅️ISO 13485 – Clause 7.4.1 Purchasing process, 7.4.2 Purchasing information, 7.4.3 Verification of purchased products ✅️FDA Quality System Regulation 21 CFR Part 820.50 – Purchasing controls ✅️USP Chapter 1083