European Medicines Agency’s Post

EMA supports GMP QRM - Good Manufacturing Practice Quality Risk Management - by training updates on 2023 ICH guidelines for European & African delegates.

Just completed my first PIC/S training on Quality Risk Management. It was an incredibly valuable experience that highlighted the importance of QRM in ensuring product quality and patient safety, and deepened my understanding of risk management strategies. #QualityRiskManagement #PICSTraining #ProfessionalDevelopment #RiskManagement #PharmaceuticalQuality #PatientSafety #GMP

🌍 Where Does GMP Come From? The foundation of GMP (Good Manufacturing Practice) traces back to 1978 when the U.S. Food & Drug Administration (FDA) introduced the CGMP (Current Good Manufacturing Practice) Guide. This groundbreaking move established the world's first legally mandated GMP regulations, allowing pharmaceutical manufacturing processes to be monitored by regulatory authorities. 📜 In the same year, Germany's Medicines Act (AMG) was published in response to the thalidomide tragedy. However, it lacked specific GMP requirements until 1985, when the "Pharma-Betriebsverordnung" introduced concrete GMP standards, setting the stage for inspections and monitoring. 🇪🇺 On a European level, the EC GMP Guidelines were adopted in 1989, and these guidelines have been binding across Europe since. In Germany, they became legally valid in 2005 under the AMWHV §2 as the EU GMP Guideline, making compliance mandatory for pharmaceutical companies. At #Cefea, we are committed to upholding the highest GMP standards to ensure the safety, quality, and efficacy of the medicines we produce. 💊 #GMP #Pharmaceuticals #Compliance #FDA #Regulations #QualityControl #Cefea #Pharma

As I dive deeper into pharmaceutical regulations, I’ve encountered an interesting case study on Good Manufacturing Practices (GMP) in Brazil, highlighting both the challenges and successes in ensuring product safety. GMP is crucial for maintaining the quality and efficacy of medications, and in Brazil, ANVISA plays a key role in enforcing these standards. A standout example is the case of EMS S/A, where ANVISA’s 2018 inspection uncovered several compliance issues, including lapses in quality control, documentation, and staff training. In response, EMS took swift corrective actions to address these gaps, demonstrating the significant impact that GMP compliance (or non-compliance) can have on public health. While challenges like resource limitations and resistance within the industry remain, ANVISA’s continued efforts to streamline inspections and improve training are crucial for enhancing compliance across the sector. The case of EMS serves as a reminder of the importance of robust GMP systems in safeguarding public health and maintaining trust in the pharmaceutical industry. This case reinforces the need for constant vigilance and adaptation in regulatory frameworks, especially in a rapidly evolving industry like pharmaceuticals. #GMP #Pharmaceuticals #ANVISA #Regulations #PublicHealth #Compliance Special thanks to Professor Elizabeth (Liz) Haines for guiding me through the complexities of pharmaceutical regulations!

🌍 Ensuring Compliance in Pharma: New EMA Guidance on GMP & GDP 🌍 For professionals in the pharmaceutical industry, maintaining compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) is vital to ensure product quality and patient safety. The European Medicines Agency (EMA) has just released comprehensive Guidance on GMP and GDP: Questions and Answers, addressing key concerns and providing clarity on industry best practices for manufacturing and distribution of medicinal products. This document is an essential resource for those working in pharmaceutical production, distribution, and regulatory compliance. 🔑 What’s inside: Clear answers to frequently asked questions on GMP and GDP Practical insights for ensuring regulatory compliance across the pharmaceutical supply chain Key guidance on maintaining high-quality standards from manufacturing to distribution 📥 Stay informed and up-to-date with these critical industry standards! 🔗 Access the full guidance here: EMA Guidance on GMP & GDP #Pharmaceuticals #GMP #GDP #Compliance #RegulatoryAffairs #QualityManagement #MedicinalProducts #EMA #PharmaIndustry #HealthcareRegulation

I'm happy to announce that I've completed my Good Manufacturing Practices (GMP) certification from Pharmuni. This milestone enhances my ability to ensure the highest standards of quality and regulatory compliance in the pharmaceutical industry.  Throughout the course, I gained in-depth knowledge and practical insights into GMP regulations, quality assurance, and best practices for ensuring product safety and efficacy. I am eager to apply these learnings to contribute to the excellence and integrity of pharmaceutical manufacturing processes. #GMP #Certification #PharmaceuticalIndustry #QualityAssurance #RegulatoryCompliance #ProfessionalDevelopment

The African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD) becomes a new PIC/S Associated Partner Organisation Geneva, 15 January 2025: The PIC/S Committee has granted the status of Associated Partner Organisation to the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD). With a shared dedication to safeguarding public health and safety, PIC/S and AUDA-NEPAD have decided to establish a cooperation agreement in the field of Good Manufacturing Practice (GMP) standards and quality systems for pharmaceutical products and Active Pharmaceutical Ingredients (API). The scope of the cooperation agreement includes : -         Facilitating pre-accession and accession processes to PIC/S for National Regulatory Authorities (NRA) members of the African Medicines Agency (AMA); -         Training of inspectors in the field of GMP; -         Participating at each other’s meetings. With the active contribution of other stakeholders, collaboration activities will aim at supporting capacity and confidence building among African NRA and at guiding them on their journey toward becoming PIC/S Participating Authorities. The agreement is also a great opportunity for both partners to develop exchanges of information and share experiences. This partnership reflects PIC/S commitment to strengthening global harmonization and cooperation in the field of GMP.   We look forward to working closely with our partners and stakeholders to achieve these goals and foster a more robust regulatory environment worldwide. An official welcome will be given to AUDA-NEPAD at the next PIC/S Committee meeting, which will take place in Geneva on 14 and 15 April 2025.

🌍 Important Update from the EMA: IDMP Implementation in Europe 🌍 The European Medicines Agency (EMA) has released Chapter 1 of the Product Management Service (PMS) guidelines regarding the Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP). This chapter outlines key registration requirements as of December 12, 2024. Key Highlights: ISO Standards Implementation: The IDMP standards are crucial for the unique identification of medicinal products, enhancing safety and regulatory compliance across Europe. Registration Requirements: Detailed guidance on the necessary steps and documentation for the registration of medicinal products to ensure alignment with ISO standards. By standardizing product identification processes, the EMA aims to improve traceability, reduce errors, and ultimately enhance patient safety within the medicinal product lifecycle. Pharmaceutical manufacturers, regulatory affairs professionals, and stakeholders are encouraged to review these guidelines and prepare for the upcoming requirements. Stay informed and ensure your compliance strategies are aligned with the latest regulations! #EMA #IDMP #ISOStandards #PharmaceuticalIndustry #MedicinalProducts #RegulatoryAffairs #PatientSafety #Compliance #Healthcare #Pharmaceuticals

GDP - What is it? 💊 GDP (Good Distribution Practice) is a standard designed to ensure the quality and safety of pharmaceutical products during distribution. The Path to Certification 🔬 To obtain GDP certification, Integre Trans must create and implement a distribution practice system that meets these standards' requirements. This involves conducting risk assessments, developing procedures, training employees, and conducting regular audits. An independent certification body performs an audit to verify compliance with the standard. Only by successfully passing the audit can we receive the certification. Benefits for Customers 🧴 GDP certification ensures that Integre Trans adheres to the highest distribution practice standards, guaranteeing the quality and safety of pharmaceutical products. This gives customers confidence in our products and services. Why It’s Worth It 💉 The certification helps Integre Trans ensure the quality and safety of pharmaceutical products, reduce risks, and comply with regulatory requirements. It also enhances our reputation and market appeal and opens opportunities to expand the business in international markets. #GDP #PharmaceuticalSafety #QualityStandards #IntegreTrans #Certification