How to manage risks in Malaysia's PSC with digital technologies

Now chapter one also under revision - has there ever been a more opportune time for #overhauleugmps If chapter one becomes the PQS / QMS with emphasis on risk based thinking and management review and deviations / change management - then take out PQS sections from all other chapters and annexes and take out QRM - just reference chapter 1 and ICH Q9. Update the intro and update the glossary and keep the chapters and annexes to what to do… please???

The European Commission have released for consultation the following document: Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1 - European Commission. The deadline for commenting is 3rd December. Changes included in this draft: -The use of risk-based drug shortage prevention and mitigation activities with respect to product quality/manufacturing risks should be considered. QRM and KM as early warning systems for manufacturing / quality risks incl. shortage issues - Management of external product availability risks relating to quality/manufacturing, (e.g., from raw material suppliers, contracted organisations, service providers, etc.) - Updated section on PQR - Review of trend data and regulatory background, grouping strategies - QRM for qualification/validation of process control systems, - Assurance of product quality based on QRM throughout the product lifecycle: In this regard, knowledge should be used to make informed decisions, trigger re-evaluations and stimulate continual improvement. - Addition of Q9 elements: Subjectivity, level of formality and risk review

𝑺𝒖𝒓𝒗𝒆𝒚𝒊𝒏𝒈 𝑨𝒏𝒂𝒍𝒚𝒕𝒊𝒄𝒂𝒍 𝑻𝒐𝒐𝒍𝒔 𝑭𝒐𝒓 𝑪𝒐𝒎𝒃𝒊𝒏𝒂𝒕𝒊𝒐𝒏 𝑷𝒓𝒐𝒅𝒖𝒄𝒕 𝑻𝒆𝒔𝒕𝒊𝒏𝒈 In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses 𝐂𝐡𝐚𝐩𝐭𝐞𝐫 𝟏𝟏 on analytical testing from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Jennifer Riter. Susan and Jennifer share insights on analytical methods for testing compatibility, performance, stability, and safety when combining drugs or biologics with delivery devices and device constituent parts. 𝑬𝒑𝒊𝒔𝒐𝒅𝒆 𝒍𝒊𝒏𝒌: https://lnkd.in/ep3ugjHE 𝑮𝒆𝒕 𝒚𝒐𝒖𝒓 𝒄𝒐𝒑𝒚 𝒐𝒇 𝑻𝒉𝒆 𝑪𝒐𝒎𝒃𝒊𝒏𝒂𝒕𝒊𝒐𝒏 𝑷𝒓𝒐𝒅𝒖𝒄𝒕𝒔 𝑯𝒂𝒏𝒅𝒃𝒐𝒐𝒌: A Practical Guide for Combination Products and Other Combined Use Systems—now available from CRC Press: https://lnkd.in/ekwC8xv2 𝑩𝒐𝒐𝒌 𝒂 𝒄𝒐𝒏𝒔𝒖𝒍𝒕𝒂𝒕𝒊𝒐𝒏: https://lnkd.in/eHc7g5h7 Management Systems GMP Consulting Training Combination Products Regulatory Affairs Guidance Executive Advisory Guidance and Support Multigenerational Planning/Roadmaps Culture Change Management Program Management Design & Process Excellence; Design Thinking Quality System Audits QMS Remediation Connections and Communications with Regulators #CombinationProducts #AnalyticalTesting #DrugDeviceCombo #PatientSafety #CRCPress

𝐁𝐫𝐢𝐝𝐠𝐢𝐧𝐠 𝐓𝐡𝐞𝐨𝐫𝐲 𝐚𝐧𝐝 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞: 𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐢𝐧𝐠 𝐀𝐐𝐛𝐃 𝐢𝐧 𝐀𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐌𝐞𝐭𝐡𝐨𝐝𝐬 Ensuring analytical methods are 𝐫𝐨𝐛𝐮𝐬𝐭, 𝐫𝐞𝐥𝐢𝐚𝐛𝐥𝐞, 𝐚𝐧𝐝 𝐟𝐢𝐭-𝐟𝐨𝐫-𝐩𝐮𝐫𝐩𝐨𝐬𝐞 is a persistent challenge in pharmaceutical development. The 𝐀𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐛𝐲 𝐃𝐞𝐬𝐢𝐠𝐧 (𝐀𝐐𝐛𝐃) framework offers a systematic alternative to trial-and-error, yet practical guidance has been limited. This paper by 𝐀𝐦𝐫𝐮𝐭𝐚 𝐁𝐚𝐢𝐫𝐚𝐠𝐢, 𝐑𝐮𝐭𝐮𝐣𝐚 𝐊𝐨𝐭𝐡𝐫𝐮𝐤𝐚𝐫, 𝐇𝐞𝐦𝐚𝐧𝐭 𝐂𝐡𝐢𝐤𝐡𝐚𝐥𝐞, 𝐒𝐫𝐞𝐲𝐚 𝐊𝐨𝐬𝐚𝐧𝐚𝐦 & 𝐋𝐚𝐱𝐦𝐢𝐤𝐚𝐧𝐭 𝐁𝐨𝐫𝐬𝐞 (𝟐𝟎𝟐𝟒) presents a 𝐬𝐭𝐞𝐩𝐰𝐢𝐬𝐞, 𝐮𝐬𝐞𝐫-𝐟𝐫𝐢𝐞𝐧𝐝𝐥𝐲 𝐚𝐩𝐩𝐫𝐨𝐚𝐜𝐡 to applying AQbD in method development. 𝐂𝐨𝐫𝐞 𝐂𝐨𝐦𝐩𝐨𝐧𝐞𝐧𝐭𝐬 • 𝐀𝐧𝐚𝐥𝐲𝐭𝐢𝐜𝐚𝐥 𝐓𝐚𝐫𝐠𝐞𝐭 𝐏𝐫𝐨𝐟𝐢𝐥𝐞 (𝐀𝐓𝐏) – structured definition of method requirements • 𝐑𝐢𝐬𝐤-𝐛𝐚𝐬𝐞𝐝 𝐩𝐚𝐫𝐚𝐦𝐞𝐭𝐞𝐫 𝐬𝐞𝐥𝐞𝐜𝐭𝐢𝐨𝐧 – identifying CMPs & CQAs • 𝐃𝐞𝐬𝐢𝐠𝐧 𝐨𝐟 𝐄𝐱𝐩𝐞𝐫𝐢𝐦𝐞𝐧𝐭𝐬 (𝐃𝐨𝐄) – establishing MODR for robustness • 𝐋𝐢𝐟𝐞𝐜𝐲𝐜𝐥𝐞 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 – enabling flexibility and long-term reliability 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬 • Provides a 𝐜𝐨𝐧𝐜𝐫𝐞𝐭𝐞 𝐫𝐨𝐚𝐝𝐦𝐚𝐩 for AQbD implementation • 𝐑𝐢𝐬𝐤 𝐚𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 and 𝐃𝐨𝐄 are essential to building robust methods • Aligns with 𝐈𝐂𝐇 𝐐𝟐 (𝐑𝟐) and 𝐈𝐂𝐇 𝐐𝟏𝟒, supporting regulatory compliance • AQbD reduces 𝐎𝐎𝐓/𝐎𝐎𝐒 𝐫𝐞𝐬𝐮𝐥𝐭𝐬 and minimises costly revalidations 𝐂𝐨𝐧𝐜𝐥𝐮𝐬𝐢𝐨𝐧 This structured AQbD workflow bridges theory with practice, enabling a 𝐬𝐲𝐬𝐭𝐞𝐦𝐚𝐭𝐢𝐜, 𝐫𝐞𝐩𝐫𝐨𝐝𝐮𝐜𝐢𝐛𝐥𝐞, 𝐚𝐧𝐝 𝐟𝐥𝐞𝐱𝐢𝐛𝐥𝐞 approach to analytical lifecycle management. ⫷ 𝗙𝘂𝗹𝗹 𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝗿𝗲𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝘀 ⫸ #AnalyticalQuality #AQbD #ICHQ14 #PharmaceuticalAnalysis #QualityByDesign

74% of pharma companies hold regular supplier performance reviews—but are they driving real value? State of Flux’s 2024 SRM report reveals a sharp drop in pharma’s ability to quantify supplier relationship benefits. KPIs, platforms, and role clarity are slipping—alongside other emerging challenges in supplier management across the industry. What does meaningful supplier relationship management look like in 2025?

How Commissioning Builds Resilience in Pharma Supply Chains Pharma supply chains are only as strong as the commissioning behind them. Unreliable commissioning leads to broken links: delayed facilities, failed audits, and bottlenecks that procurement can’t fix after the fact. The Insight Strong commissioning means strong supply chains. Why? Because: →  Systems are qualified on time →  Regulatory inspections are passed confidently →  Procurement has predictable workflows →  In an unpredictable world, resilience is procurement’s greatest ROI. The Action Procurement professionals: the next time you negotiate commissioning, think resilience, not just cost. It’s the investment that keeps your supply chain steady when markets shake. 👉 How do you define resilience in your procurement strategy? Follow Commissioning Partners #PharmaCommissioning #SupplyChainResilience #ProcurementExcellence #CommissioningLeadership #PharmaProjects

Understanding Stability Conditions in Pharmaceuticals 🌡️ In drug development, ensuring a product’s quality, safety, and efficacy throughout its shelf life is non-negotiable. That’s where stability testing comes in — simulating different environmental conditions to determine how long a product can remain safe and effective. 💡 Key Stability Testing Types: 🔹 Long-term – Real-time storage conditions (12–24 months) 🔹 Intermediate – For borderline cases (6 months) 🔹 Accelerated – Stress testing to predict shelf life quickly (6 months) 🔹 Special conditions – For refrigerated, frozen, or light-sensitive products ✅ Based on ICH guidelines, these tests guide expiry dates, storage instructions, and regulatory approval. 📊 Check out the infographic to see all testing conditions at a glance. 💬 How does your organization handle stability studies for global markets with different climate zones?

💡Digitization isn't just a buzzword — it's a compliance imperative. In pharma and nutraceutical manufacturing, manual logs and paper records are no longer enough. Regulatory audits now demand traceable, standardized, and accurate data — from R&D to production. This article walks you through: 🔹 Why digitized testing data is crucial 🔹 Where manual workflows put you at risk 🔹 How HUANGHAI’s lab instruments support digital records (USB, print, structured formats) 🔹 The future of data-driven QA in pharma 🧪 Read now: https://lnkd.in/g988kqR3 #PharmaCompliance #GMP #PharmaceuticalTesting #LabDigitization #HUANGHAI #ODF #Nutraceuticals

Introducing The WCAworld Academy GDP Accreditation Audit Program 🌍💊 The pharmaceutical and healthcare distribution network is complex. Improper handling can lead to product damage, temperature excursions, and theft resulting in costly losses. As global regulations tighten, particularly under the EU’s GDP guidelines, there is an urgent need for companies to align with best practices and demonstrate supply chain integrity. WCAworld Academy’s Good Distribution Practice (GDP) Accreditation Program offers a structured pathway to compliance. This program helps companies validate processes and facilities against global GDP standards—ensuring transparency, safety, and reliability. Learn more: https://lnkd.in/gtdxmjia #WCAworldAcademy #WCAworld #PharmaLogistics #GDPCompliance #SupplyChainExcellence

🔍✨ Turning data into action in pharma manufacturing At Hikma Pharmaceuticals Columbus, the 🚀 Digital Factory platform is giving leaders and operators the tools they need to see what’s really happening on the floor—⚡ in real time. With 📊 live dashboards and 🔎 production insights, teams can spot issues faster, close performance gaps, and push continuous improvement forward. The results speak loud and clear: ⏱️ 18% shorter changeovers 📈 12-point jump in OEE 💰 Stronger profitability and efficiency gains When the right people get the right data at the right time 👉 performance doesn’t just improve—it accelerates ⚡🚀. 📖 Read the full Hikma success story here: https://lnkd.in/gVsvp26B #PharmaManufacturing #DigitalFactory #OperationalExcellence #SmartManufacturing #SCWAI #Hikma #OEE #DataDrivenSuccess #DigitalTransformation