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Understanding GMP Guidelines: Ensuring Quality in Every Step At 𝗛𝗠𝗦 𝗨𝗻𝗶𝘃𝗲𝗿𝘀𝗮𝗹, we prioritize compliance with Good Manufacturing Practices (GMP) to guarantee the highest quality in every product we handle. GMP guidelines are crucial in industries like pharmaceuticals, food, and medical devices to ensure that products are consistently produced and controlled according to stringent quality standards. 𝗞𝗲𝘆 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗼𝗳 𝗚𝗠𝗣: 𝗛𝘆𝗴𝗶𝗲𝗻𝗲: Maintaining a clean and hygienic production environment to prevent contamination. 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁: Monitoring conditions such as temperature and humidity to preserve product integrity. 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗖𝗼𝗻𝘁𝗿𝗼𝗹: Strict documentation and adherence to procedures for manufacturing, processing, and storage. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: Implementing thorough quality assurance to ensure each batch meets required standards. 𝗧𝗿𝗮𝗶𝗻𝗲𝗱 𝗣𝗲𝗿𝘀𝗼𝗻𝗻𝗲𝗹: Ensuring that all staff involved in production are well-trained and qualified. 𝗪𝗵𝘆 𝗚𝗠𝗣 𝗠𝗮𝘁𝘁𝗲𝗿𝘀? GMP guidelines are recognized worldwide and ensure that consumers receive safe, effective, and high-quality products. At 𝗛𝗠𝗦 𝗨𝗻𝗶𝘃𝗲𝗿𝘀𝗮𝗹, we take pride in adhering to these guidelines to protect our customers' trust and meet regulatory requirements. By doing so, we safeguard product integrity, public health, and our reputation.

WHY 4S4P Flexibility, know-how and rapid reaction time. These are the key success factors for modern companies to compete within global markets characterized by high specialization, growing competitiveness, increasingly complex regulations and reduced Time-to-Market.   4S4P provides consultancy and hands-on assistance to HealthCare companies within the Pharmacovigilance, Medical Affairs, Regulatory Affairs and Quality fields, offering strategic and operational experience which, when combined with company know-how and strategies, allows rapid attainment of excellent results.   4S4P is committed to constant professional improvement and updating in order to maintain the elevated qualitative standards which result in its success.    4S4P does not promote its activities: this is already done by our customers which every year renew their trust on our organization and recommend us to Italian and foreign companies. 

The Ministry of Health, Labor, and Welfare (MHLW) in Japan plans to start a new initiative aimed at boosting the skills of inspectors working under the Good Manufacturing Practice (GMP) guidelines. This initiative will involve sharing inspection reports from across the nation, a move led by the Pharmaceuticals and Medical Devices Agency (PMDA). The goal is to ensure that the quality of GMP inspections is consistent throughout the country, giving inspectors insight into a wider array of compliance issues, such as complex violations including fraudulent bookkeeping and product fabrication. This new approach is geared to enhance the capability of inspectors to recognize and stop regulatory violations earlier and more effectively. Read more: https://lnkd.in/gTHxDxzw

When is QP certification required? Answer: QP certification is a legal requirement when IMP has been manufactured in the EU/UK or imported into the EU/UK from third countries for clinical trial use. The QP certification is a release from a QP, confirming that the IMP has been manufactured to EU/UK GMP standards and is safe for use by patients.

With the onset of 𝐍𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐖𝐞𝐞𝐤; let's demystify certain facts and get in touch with the reality about GMP practices. 𝐌𝐲𝐭𝐡- GMP is related to cleanliness in production areas and is limited to hygiene practices. 𝐅𝐚𝐜𝐭: GMP includes everything from quality control to employee training, ensuring consistent, high-quality products. It’s much more than just cleanliness! Stay aware; stay compliant with RedLotus Pharmtech. Contact us to know more. https://lnkd.in/dS846j6Y #GMPConsultingServices #GMPComplianceServices #GMPAuditConsultant #GMPConsulting #GMPComplianceTesting #NationalPharmaceuticalWeek

The U.S. Food and Drug Administration has published a final rule to implement the most significant revisions in the FDA’s quality system requirements for medical devices in decades, known as the Quality Management System Regulation, which will largely replace the FDA’s existing Quality System Regulation with ISO 13485. In this article published by the Journal of Medical Regulation, Pamela Forrest and Amy Leiser summarize the content of the #QMSR, key differences between the QSR and QMSR, and steps that manufacturers should take to prepare for implementation of the QMSR: https://okt.to/ImupEQ

Hi Charlotte Downing, 𝗖𝗼𝗻𝗴𝗿𝗮𝘁𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀, 𝗮𝗻𝗱 𝘄𝗲𝗹𝗹 𝗱𝗼𝗻𝗲 𝗼𝗻 𝘁𝗵𝗶𝘀. Charlotte covered the following areas on this programme: - Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation - Industry regulations and guidelines for GMPs – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation - FDA medical device rules – medical device regulations & and guidelines - GMPs vs ISO 9001:2015 – what’s the difference and why we use both - Process validation and documentation – design and verification of manufacturing systems - Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic and sterile manufacturing - Supporting technologies  – such as purified water generation, storage and distribution, clean steam, water for injection, storage and distribution - Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application - Working in a cleanroom environment – layout, classification, gowning and monitoring - Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry For an end-of-module assignment, Charlotte completed a report on the cGMPs that are required to consistently manufacture safe medicines, vaccines and medical devices for patients. It included: - The key requirements of a quality management system - The cleaning validation sequence and how to determine cleanliness levels - The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk. - The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients - The generation, storage and distribution of pharmacopoeia grade Purified Water (PUW). - The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment Well done again on your hard work. 

*Sneak Preview JMDR May 2024 issue* ✨US FDA finalises rule incorporating ISO 13485 into new Quality Management System Regulation (QMSR)✨ On 2 February 2024, the Food and Drug Administration (FDA) published a final rule to implement the most significant revisions in the FDA’s quality system requirements for medical devices in decades. Specifically, the final rule – known as the Quality Management System Regulation (QMSR) – will largely replace the FDA’s existing Quality System Regulation (QSR) with ISO 13485. The final rule also makes conforming edits to clarify the device Quality Management System requirements for combination products. This article by Pamela Forrest and Amy Leiser summarises the content of the QMSR, key differences between the QSR and QMSR, and steps that manufacturers should take to prepare for implementation of the QMSR. #regulatoryaffairs #medicaldevices #iso13485 #usfda #qsr #qmsr #dispositivosmedicos #dispositifsmedicaux #medizinprodukte #medtech #dispositivimedici #qualitymanagementsystem Subscribe now so you don't miss the full story: 👉 https://lnkd.in/dCyF49rt

🔍 TPM vs. GMP In manufacturing, both Total Productive Maintenance (TPM) and Good Manufacturing Practices (GMP) play crucial roles, but they focus on different aspects: ⚙️ TPM: Aims to maximize equipment efficiency, minimize downtime, and empower operators to maintain and improve machines. It’s all about productivity and performance! 🧪 GMP: Focuses on ensuring the safety and quality of products by adhering to strict standards in hygiene, processes, and documentation. It’s essential for industries like food, pharmaceuticals, and cosmetics. Both are key to success, but while TPM ensures smooth operations, GMP guarantees safe, high-quality outcomes. 👌 #ManufacturingExcellence #TPM #GMP #QualityControl #Productivity

What are the sampling requirements for sterility testing when a finished product batch of a terminally sterilised medicinal product is made up of more than one steriliser load? The sampling plan for sterility testing should take account of the definition of a batch as stated in the glossary of the GMP guideline together with the recommendations of the new annex 1 section 10.6, each steriliser load is considered to be an independent sub-batch. Consequently, one sterility test should be performed per sub-batch.