Achmad Fadhil Almasyhur’s Post

Exciting news for the pharmaceutical industry! Our new vendor/supplier audit service for raw materials and packaging is here. Our experienced and independent auditors provide detailed scoring and recommendations for audited vendors, ensuring minimized risks in vendor selection. You'll receive ready-made reports and validation in choosing the right vendor. What's more? Our service offers time and effort efficiency, and enhanced quality assurance. We're specifically targeting vendors outside of Indonesia. If you're interested in learning more, please feel free to send message or comment for further discussion. And, if you find this post valuable, please share it with your network. #pharmaceuticals #certification #TUVNordIndonesia #vendoraudit #assurance #quality #BPOM #auditbahanbaku #auditvendor #auditsupplier #farmasi

Join Our Free Webinar: Elevating Supply Chain Standards in Pharma & Cosmetics Are you in the pharmaceutical or cosmetic industry? It's time to sharpen your competitive edge with ISO 9001-driven supplier audits! 📈 PT. TÜV NORD Indonesia proudly offers an exclusive webinar to empower your supply chain with robust audit strategies. Gain insights on enhancing supplier performance, ensuring compliance, and driving quality across every link of your supply chain. 👩💻 What You'll Discover: 1. Best practices in supplier audits tailored for the pharmaceutical and cosmetic sectors. 2. How to align your supplier assessment procedures with ISO 9001 standards. 3. The pivotal role of supplier audits in maintaining product excellence and regulatory compliance. 4. Strategies to leverage audit outcomes for continuous supplier development. 🔍 Webinar Details: Date: 4th April 2024 Time: 10:00 - 12:00 WIB Platform: Online via Zoom Cost: Free! 📝 Reserve Your Spot! Secure your place by scanning the QR code in the image, or contact Adam Firdaus for more information. Take advantage of this opportunity to revolutionize your supplier audit process and achieve supply chain excellence! 🔗 Scan. Register. Excel. With PT TÜV NORD Indonesia, your journey to quality begins here. #SupplierAudit #ISO9001 #PharmaQuality #CosmeticIndustry #SupplyChainExcellence #PTTÜVNORD #FreeWebinar

Maintaining high standards in the pharmaceutical industry's supply chain is crucial at PT. TÜV NORD Indonesia offers supplier audit services integrated with ISO 9001 Quality Management Systems and CPOB standards to guarantee product quality and compliance. By aligning supplier audits with ISO 9001 and CPOB standards, companies can streamline their processes, reduce redundancy, and ensure that all quality and compliance measures are met. This comprehensive view of supplier practices enhances oversight and control over the supply chain, while the feedback from these audits helps suppliers continually improve their processes. We invite you to partner with us at PT. TÜV NORD Indonesia, through Adam Firdaus, ensures that your pharmaceutical supply chain upholds the highest quality and compliance standards. #SupplierAudit #ISO9001 #CPOB #PharmaceuticalQuality #SupplyChainManagement #QualityManagement #Compliance #RiskManagement #TÜVNORDIndonesia

🎉 From March 11th to 14th, 2024, following the completion of the #GMP on-site audit in #Brazil, #Infliximab Injection received its second audit from #Indonesia's BPOM, a PIC/S member country. 🙌 During this audit, the BPOM audit team conducted a comprehensive review of the production quality system of Infliximab Injection based on PIC/S guidelines, WHO guidelines, Indonesian GMP, and the Indonesian Pharmacopoeia. The audit scope covered storage, formulation, raw material production, #QC laboratories, and quality management systems. The audit team affirmed the GMP management level of this product. 🏅 This audit not only facilitates the alignment of the product's quality system with international regulations, but also signifies a significant step forward in the commercialization process of this product in the Indonesian pharmaceutical market. Additionally, it will strongly promote the entry of Infliximab products into other emerging markets. 🌍 With multiple products undergoing overseas audits in various countries, Kexing Biopharm's overseas brand influence is steadily increasing.

Transform Your Supply Chain with Rigorous Supplier Audits Quality is not just a standard; it's a promise to your customers at PT. TÜV NORD Indonesia understands suppliers' critical role in maintaining the impeccable quality of your pharmaceutical and cosmetics products. That's why we emphasize the significance of our comprehensive supplier audit services—your first step towards securing a supply chain that meets the highest quality and compliance standards. Introducing the WAVe program, our unique approach to supplier verification. This program ensures that your products are crafted from materials that adhere to global benchmarks of excellence. WAVe is a testament to our commitment to fostering sustainable, quality-driven supply chains across industries. Choose integrity. Choose reliability. Let our supplier audit services and the WAVe program safeguard your product quality and elevate your brand's reputation. #SupplierAudit #QualityControl #WAVeProgram #PTTUVNORDIndonesia

Exploring Supplier Audits: Internal vs. 3rd Party Auditor Are you pondering the best approach for supplier audits? Let's delve into the impact of utilizing a third-party auditor versus relying solely on internal resources. 1.Internal Auditor: -Familiarity: Internal auditors possess in-depth knowledge of the company's processes, systems, and expectations. -Cost-effective: Utilizing internal auditors can often be more cost-effective than outsourcing to a third party. -Alignment: Internal auditors are aligned with company objectives and can ensure audits reflect organizational priorities. However, there are limitations to consider: *Bias: Internal auditors may overlook or downplay issues due to familiarity or loyalty to the company. *Resource Constraints: Internal auditors might face time constraints or lack specialized expertise required for comprehensive audits. 2.Third-Party Auditor: -Objectivity: External auditors offer an unbiased perspective, free from internal influences or biases. -Specialized Expertise: Third-party auditors often bring specialized skills and experience to the table, offering fresh insights. -Scalability: Third-party auditors can scale resources based on audit requirements, providing flexibility. Yet, there are potential drawbacks: *Cost: Engaging third-party auditors can incur additional expenses, including fees and travel costs. *Limited Understanding: External auditors may lack nuanced understanding of internal processes and company culture. Ultimately, the choice depends on your organization's specific needs, resources, and the criticality of the audit. Combining both approaches, such as using internal auditors for routine checks and third-party auditors for periodic deep dives, can yield a balanced audit strategy, ensuring thoroughness and objectivity. What's your preferred approach, and why? Let's discuss! #SupplierAudit #CPOB #PharmaceuticalManufacturing #QualityAssurance #Compliance #TÜVNORDIndonesia

Managing pharmaceutical logistics and the supply chain requires precision and expertise. From procurement to delivery, every step demands meticulous attention to detail and compliance with stringent regulations. Effective coordination and communication are key to ensuring seamless operations and maintaining product integrity.

I had the privilege to attend 12th Annual Meeting on WHO Collaborative Registration Procedure from 12-14 November 2024 in Jakarta, Indonesia. The meeting provided us opportunity to interact with assessors from over 50 National Regulatory Authorities and WHO. We learnt experiences of various NRAs in implementation of WHO CRP for grant of marketing authorization through expedited pathways along with Post Approval Changes (PAC). The meeting also covered WHO SRA CRP which provides a mean for introduction of innovator products as well as SRA approved generic products in all countries. As a way forward, electronic pre-qualification system ePQS was also introduced as a pilot project which would enable easy sharing of information within WHO, NRAs as well as the pharmaceutical firms. This would also enable NRAs to have information about all PACs for WHO PQ products.

Regulatory Affairs Officer Division is part of the company that handles product registration in accordance with the applicable government regulations until obtaining approval from the authorities. The Regulatory Affairs Officer is Managing the submission of product registration documents, registering product licenses, and keeping track of when the product license expires. Roles and responsibilities of Regulatory Affairs Officer include: - Understanding product-related regulations and changes. - Registering pharmaceutical products with the Indonesian Food and Drug Administration (BPOM) to obtain distribution permits. - Internal coordination within the company: New Product Development (NPD), marketing. - Compiling and documenting registration documents. It's a privilege to have gained valuable insights into Regulatory Affairs from the expertise of Siti Syifa Printiarti. My gratitude extends to the event organizers and the exceptional speaker. #regulatoryaffairs #pharmaceuticalindustry

This guideline aligns with the requirements of the #WHO Good Manufacturing Practices (GMP) for pharmaceutical products and the international standard #ISO/IEC17025. It offers comprehensive guidance for laboratories conducting quality control testing of #medicines. 💠 NEW REQUIREMENTS TO BE IMPLEMENTED 💠 Introducing a new section (Section 4) on Planning and Strategic Management, which includes: Performance Management Quality Risk Management Crisis Management Communication Management Measurement of Uncertainty