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Tips for Handling Deviations in Pharmaceutical Manufacturing What is GMP Deviation? Handling Good Manufacturing Practice (GMP) deviations are instances where a pharmaceutical manufacturer fails to comply with the guidelines set forth by regulatory bodies such as the European Union Good Manufacturing Practice (EUGMP), the Food and Drug Administration (FDA), the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Pharmaceutical Inspection Co-operation Scheme (PICs). These deviations can occur at any stage of the manufacturing process and can result in substandard or unsafe products reaching consumers. In order to ensure the safety and efficacy of pharmaceutical products, it is essential for manufacturers to promptly identify and correct any GMP deviations. Read Full Article HERE https://lnkd.in/dqBeQZZ5

Tips for Handling Deviations in Pharmaceutical Manufacturing

💡 𝐓𝐡𝐞 𝟏𝟎𝐭𝐡 𝐞𝐝𝐢𝐭𝐢𝐨𝐧 𝐨𝐟 𝐭𝐡𝐞 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞 𝐨𝐟 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬: 𝐚 𝐜𝐨𝐦𝐩𝐞𝐧𝐝𝐢𝐮𝐦 𝐨𝐟 𝐠𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞𝐬 𝐚𝐧𝐝 𝐫𝐞𝐥𝐚𝐭𝐞𝐝 𝐦𝐚𝐭𝐞𝐫𝐢𝐚𝐥𝐬, lauched by the World Health Organization in February 2024, is an essential resource for the global healthcare community, designed to strengthen pharmaceutical standards worldwide. 🔦 The compendium, developed for national regulatory authorities, pharmaceutical manufacturers, healthcare professionals, and procurement agencies, is instrumental in upholding the globally acceptable standards of good manufacturing practices (GMP) and inspections. With forty-six guidelines, including eight new and ten revised ones, it provides a comprehensive framework for enhancing regulatory systems and international standards for pharmaceutical quality assurance. https://lnkd.in/eNuAftHy

The Backbone of Bioequivalence Studies and Regulatory Filing RLD (Reference Listed Drug) is a crucial concept in the pharmaceutical industry, playing a vital role in bioequivalence (BE) studies and regulatory filing. What is RLD? RLD is a drug product listed in the FDA's Orange Book It is the innovator drug product that is used as a reference for generic or abbreviated new drug applications (ANDAs) RLD is the standard against which bioequivalence is measured Requirements for BE Study: The RLD must be used as the reference product in BE studies BE studies must be conducted in accordance with FDA guidelines The test product must demonstrate bioequivalence to the RLD Requirements for Regulatory Filing: The RLD must be identified in the ANDA or NDA submission The submission must include a list of the RLD's active ingredients, dosage form, and route of administration The submission must demonstrate bioequivalence to the RLD Significance: RLD ensures that generic or ANDA products meet the same standards as the innovator drug RLD facilitates the approval process for generic drugs RLD helps maintain drug consistency and quality RLD and its requirements, pharmaceutical professionals can navigate BE studies and regulatory filing with ease, ensuring the development of safe and effective drugs. #RLD #Bioequivalence #RegulatoryFiling #PharmaceuticalIndustry #DrugDevelopment #FDA #OrangeBook

ICH – International Conference on Harmonisation The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was formed in 1990 with the goal of bringing together the pharmaceutical industry and regulatory bodies of the USA, Europe and Japan (the major markets of the major companies) to drug regulation from a scientific and technical perspective. As the industry became more globalised, the ICH has adapted to promote rationalisations and harmonisation of practices to ensure that pharmaceutical products are of high quality, effective and safe, and that registration of these products is efficient across the world. At a practical level it allows a manufacturer in American to sell its products in Europe without the European regulatory authority having to audit the manufacturing plant in America, and vice versa, as the regulatory bodies will in many cases accept the audit findings of the other auditing bodies. This reduces excessive duplicate regulatory oversight and by doing that makes medicines more affordable and more affordable medicines can reach more people. The organisation has developed a number of guidelines such as: ICH Q7 – Good Manufacture Practice guidelines for Active Pharmaceutical Ingredients ICH Q8 – Pharmaceutical Development ICH Q9 – Quality Risk Management ICH Q10 – Pharmaceutical Quality Systems ICH Q11 – Development and Manufacture of Drug Substances

List of ICH guidelines that are related to Quality Assurance: Some key ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines related to Quality Assurance: 1. ICH Q1A(R2): Stability Testing of New Drug Substances and Products 2. ICH Q2(R1): Validation of Analytical Procedures 3. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 4. ICH Q8(R2): Pharmaceutical Development 5. ICH Q9: Quality Risk Management 6. ICH Q10: Pharmaceutical Quality System 7. ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) 8. ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management These guidelines provide internationally accepted standards and recommendations for ensuring the quality of pharmaceuticals throughout their development, manufacturing, and lifecycle. Stay Tuned Abu Talha B. #guidelines #ICH

Revised GMPs for Excipients and Pharmaceutical Packaging Materials have been proposed by China’s NMPA. The deadline for industry comment is August 20, 2024. The new GMP for excipients represents a substantial upgrade over the 2006 version. And the new GMP for pharmaceutical packaging materials that are in contact with drugs presents new requirements for manufacturers. Overall, there is a stronger emphasis on: ·        comprehensive quality management systems, ·        stringent change management, ·        enhanced supplier audits, ·        and rigorous regulatory supervision.  China’s drug regulatory authorities will conduct regular inspections and quality sampling of excipients and packaging materials to maintain oversight. For regulatory affairs managers of pharmaceutical drug marketing authorization holders, this means heightened responsibility in ensuring compliance and maintaining robust quality systems.  Excipients and packaging manufacturers will face increased scrutiny and will need to demonstrate adherence to stringent standards to maintain their business. Read our article to learn the key impact on drug marketing authorization holders, excipient and pharma packaging manufacturers: https://lnkd.in/dNeykmxQ #gmp #excipients #pharmaceuticals

I'm thrilled to announce that my article titled "Regulatory Framework and Quality Considerations for Launching International Active Pharmaceutical Ingredients (APIs) into the China Market" has been published in the prestigious journal Pharmaceutical Regulatory Affairs! 📝💼 This publication is a culmination of extensive research and expertise in regulatory affairs, showcasing insights into navigating the complex landscape of international API launches, particularly in the dynamic China market. I'm deeply honored to contribute to the industry's knowledge base and to share my passion for ensuring compliance and quality standards in pharmaceutical development. Read the full article here, and let's continue driving excellence in regulatory affairs together! 💪✨ #RegulatoryAffairs #Pharmaceuticals #Expertise #Publication #QualityStandards

We congratulate Dr. Vinod P. Shah on his accomplishment and honor of being awarded the Høst Madsen Medal by the International Pharmaceutical Federation (FIP). According to FIP’s announcement on September 1st, “Vinod P. Shah (USA) was today recognised for his contributions to the field of pharmaceutical science and regulatory research and their impact on policy and practice with an award of FIP’s Høst Madsen Medal. His work includes: establishing the scientific basis for the Biopharmaceutics Classification System for immediate release solid dosage forms and developing the classification system for topical drug products; developing a dissolution methodology for sparingly water-soluble drug products using a surfactant, which has been adopted by the US Food and Drug Administration (FDA) and the US Pharmacopeia; creating a procedure for comparing dissolution profiles by using similarity factor f2, which has been adopted globally by all regulatory agencies for dissolution profile comparison; and developing in vitro release methodology for semisolid dosage forms, now used in US FDA guidance.” Dr. Shah joined NDA Partners as an Expert Consultant in 2016. He has thirty years of experience at the FDA, working in different Divisions, until he retired as a Senior Research Scientist in the Office of Pharmaceutical Sciences in 2005. Learn more about Dr. Shah: https://lnkd.in/e_5CHUfk #ndapartners #pharmaceuticalscience #drugdevelopment #regulatorysciences

With the new regulation for active pharmaceutical ingredients (APIs), it is now mandatory for manufacturers of synthetic and semi-synthetic APIs to obtain ANVISA's Good Manufacturing Practices (GMP) certification for their products to be used in drug product that will be registered and marketed in Brazil. Although ANVISA allows the use of a valid API GMP certificate issued by third parties in drug product registration processes, many drug product manufacturers prefer to request this certificate by themselves. This leads API manufacturers to request multiple certifications, thereby increasing regulatory fees and process management difficulty. One solution for API manufacturers is to obtain certification through a neutral company, such as a regulatory consultancy. DC Regulatory offers expertise in evaluating documentation for obtaining the certificate, as well as support for maintaining and renewing the certificate as needed. With this partnership, drug manufacturers can be assured that the API GMP certification will not affect their registration, while API manufacturers simplify their processes and reduce regulatory costs. #APIGMPCertification #ANVISACertification #RegulatoryConsulting #DrugRegistration