Hans-Herwig Bauer

New Health Canada guidelines for NHP labelling are redefining compliance standards. If you're pursuing or advancing your regulatory career, don’t miss this breakdown of what the changes mean and how to prepare.

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𝗪𝗵𝘆 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝗹 𝗔𝘂𝗱𝗶𝘁𝘀 𝗠𝗮𝘁𝘁𝗲𝗿 𝗠𝗼𝗿𝗲 𝗧𝗵𝗮𝗻 𝗘𝘃𝗲𝗿 𝗶𝗻 𝟮𝟬𝟮𝟱 With the FDA aligning 21 CFR Part 820 with ISO 13485, internal audits are no longer just a checkbox. They’re now your frontline tool for ensuring your QMS is 𝗿𝗶𝘀𝗸-𝗯𝗮𝘀𝗲𝗱, 𝗽𝗿𝗼𝗰𝗲𝘀𝘀-𝗱𝗿𝗶𝘃𝗲𝗻, and truly effective. Under QMSR, internal audits must be: ✔️ Mandatory (ISO 13485 Clause 8.2.4) ✔️ Risk-based ✔️ Process-focused ✔️ A driver for continuous improvement See what’s changing — and why it matters. 📊 Internal audits are becoming one of the most important tools for proactive compliance. 𝗦𝘁𝗮𝘆 𝗮𝗵𝗲𝗮𝗱. 𝗦𝘁𝗮𝘆 𝗮𝘂𝗱𝗶𝘁-𝗿𝗲𝗮𝗱𝘆. #LifeSciences #QMSR #InternalAudits #ISO13485 #FDACompliance #QualityManagement #ECI

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Clarifying the meaning of FDA GMP This episode explores the frequent misunderstandings around FDA Good Manufacturing Practice and how small errors in interpretation can have significant consequences. Why listen? Strengthen your knowledge of GMP requirements and understand how to align practices with regulatory expectations to avoid costly mistakes. #FDAGMP #Compliance #DrugSafety #RegulatoryAffairs #ARCSAustralia

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Prepare your QC micro lab for smarter, smoother upgrades. This on-demand webinar walks you through how to plan equipment changes and workflow updates while avoiding compliance gaps. Hear from a former FDA expert on what to consider before making a change, how to engage regulators, and how rapid methods like Celsis support a modern, compliant approach. This on-demand webinar is also available in Spanish, French, Portuguese, and additional languages. Watch now: https://okt.to/6zdR4m #qualitycontrol #microbiology #pharma #rapidmethods #qcinnovation #CRL #MicrobialSolutions

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Looking to grow your pharma career with purpose, not guesswork? In a highly regulated industry, strategy matters. Discover how to build a clear, focused, and future-ready pharma career path—with real-world tips you can apply today. 📖 Read the full guide now and start planning your long-term success: 👉 Read the blog: https://lnkd.in/dGf62WGZ #PharmaCareer #CareerDevelopment #PharmaceuticalIndustry #RegulatoryAffairs #GMP #LifeSciences #PharmaJobs #Pharmuni #CareerTips #PharmaCareers #PharmaIndustry #ProfessionalGrowth #PharmaPathway #Pharmuni #PharmaInsights

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‼️ A 13$ billion Natural Health Products Canadian industry was not left without regulatory attention. A new version 4 of GMP guide for NHP (Natural Health Products) was published on September 04, 2025, effective March 04, 2026. This is a much more elaborate guide with detailed interpretations of regulations and the agency expectations in terms of GMP systems set-up. Just an increase in the number of pages (from 90 in ver. 3 to 170 in ver. 4) already indicates that the rules are not so simplistic anymore.  There is definitely more substance, nuances, and even new expectations. Let’s just take a look at a few sections: ✔️ Scope of application:  the guide specifically emphasizes that the GMP rules also apply to importers, those who store for retailers, and those who store to sell directly to individual consumers such as solely through an e-commerce platform ✔️ A new dedicated section on NHP quality systems is very similar in structure to that of the drugs GMP, including a requirement for a quality manual, active involvement and outline of management responsibilities, self-inspection, supplier management, and process monitoring ✔️ A new dedicated section on Quality Risk Management that recommends following the principles of ICH Q9 (even though HC acknowledges that NHPs are not in the scope of ICH guidelines) ✔️ A detailed section on Prohibition 43 includes an elaborate list of importers roles ✔️ Section 44, Specifications:  1) a new expectation to have evidence of suitability of testing methods, including accuracy, precision, linearity; 2) a clear requirement as to what polymer types can be used for NHP packaging; 3) an elaborate system requirement for supplier control, including the encouragement of confirmatory testing of at least 1 lot per year; 4) introduction of the concept of rotational testing for medicinal ingredients, i.e. skip testing, i.e. testing of each ingredient on specs at least once every 3 lots ✔️ Section 45, Premises: a strong emphasis on pest control activities and quality of water supply, including monitoring of municipal water source supply ✔️ Section 46, Equipment: requirement to have evidence that the equipment used for NHP manufacture is “fit for purpose” and to follow a formal Change Control on equipment updates   And these are just a few examples of what will be expected from NHP operators moving forward. For those already working with more mature quality systems such as pharma or medical devices, this NHP upgrade will most likely be seamless. However, if your QMS was customized for NHPs only under GMP ver.3, there is a lot of work to complete before ver.4 becomes effective. RAPS Quebec Local Networking Group #regulatoryaffairs #nhp #raps #gmp

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How to Master FDA Compliance in 6 Steps Want to ace your next FDA inspection? Start with these 6 essential steps👇 📘 1. Know the Rules Learn 21 CFR Parts 11, 210/211, and 820 inside out. 📝 2. Create Strong SOPs Document your processes clearly and train your team. 📂 3. Follow ALCOA Principles Make every record accurate, traceable, and audit-proof. 🔍 4. Run Internal Audits Find and fix issues before the FDA does. 📢 5. Track Regulatory Updates Stay informed on new FDA guidance and 483 trends. 🎓 6. Get Proper Training Don’t guess—master FDA compliance with expert-led training. 🎯 Ready to level up? Take our full course 👉 https://lnkd.in/dNHnFzZU

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CAPAs don’t fail because of paperwork. They fail because of focus. While some teams chase: - The perfect template. - The newest software. - The fastest closure. The best teams do the basics right. They contain the problem They assess the risk They investigate. They identify the root cause They determine actions They assess impact They assess risk They implement They verify effectiveness They follow up. Day after day. Audit after audit. Year after year. No shortcuts. No magic. Just disciplined execution. And that’s the secret to compliant CAPAs: Doing the “boring” steps so well that nothing slips through. Because in compliance, boring = safe. And safe = trusted. I’ve seen companies turn audit stress into confidence, not by doing more, but by doing the right steps, consistently. Your CAPAs don’t need to be complicated. They just need to be compliant.

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FDA Issues Warning to Apotex Over Serious Manufacturing Violations The FDA issued a warning letter to Apotex Inc.'s Richmond Hill facility on October 31, 2025, following an inspection that uncovered critical manufacturing deficiencies affecting sterile drug products distributed in the U.S. market. Key Violations: The company failed to adequately investigate equipment failures and product integrity issues for over a year. Between September 2023 and April 2025, personnel repeatedly performed leak tests on aseptic filling equipment until obtaining passing results, rather than investigating root causes. Over 30 areas of the system were eventually found leaking. Additional problems included container-closure integrity failures where product residue appeared under caps due to incompatible cap liners causing corrosion and leakage. Despite identifying this as "high risk," no market action was initially taken. The facility also exhibited poor equipment maintenance, with investigators observing discolored gloves, deteriorated gaskets, dried product residue, and white particle contamination from deteriorating equipment. In one incident, a six-millimeter glove breach was closed with a cable tie before continuing production. Apotex subsequently suspended manufacturing and recalled multiple products, including ophthalmic solutions and oral medications. The FDA has demanded comprehensive independent assessments of the company's investigation, quality control, and maintenance systems within 15 working days. #warningletter #noncompliance #regulatory #quality #usfda #observation https://lnkd.in/dxEkVMjZ

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Health Canada has officially ended the Foreign Site Reference Number (FSRN) process for Natural Health Products, effective February 16, 2026. This marks an important regulatory shift in how GMP evidence for foreign manufacturers is assessed under the Natural Health Products Regulations (Part 3 – GMP Requirements). 🔎 What has changed? 1. FSRNs will no longer be issued. 2. Existing FSRNs will be discontinued. 3. Foreign warehouses will no longer be required to be listed on a Canadian Site Licence. 4. GMP evidence for foreign sites must now be submitted directly within the Canadian importer’s Site Licence application. 📌 What does this mean strategically? From a regulatory standpoint, this consolidates oversight into the Site Licensing framework rather than maintaining a parallel reference-number process. The practical implication is: Canadian importers must now ensure that foreign manufacturers’ GMP evidence is robust, complete, and aligned with Health Canada expectations at the time of Site Licence submission or renewal. This also places greater emphasis on: • Quality agreements • Audit readiness • Acceptable forms of GMP evidence • Clear delineation of roles between foreign manufacturers and Canadian licence holders While the administrative burden of maintaining FSRNs is removed, the underlying GMP accountability remains unchanged. For organizations importing NHPs into Canada, this is an appropriate time to reassess: - Your foreign site documentation packages - Renewal strategies - Warehouse qualification approach - Risk-based supplier oversight model Regulatory frameworks continue to evolve toward integration and risk alignment. Staying ahead requires not just compliance but structured regulatory strategy. If your organization is navigating Site Licence amendments, renewals, or foreign GMP evidence submissions, this update warrants careful review. #HealthCanada #GMP #SiteLicence #RegulatoryAffairs #QualityAssurance #Compliance #Importation #RegulatoryStrategy #MCS #ReenaGroup

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Pass Your First GMP Audit in QC Nail the basics. Show control. Prove data integrity. 🚀 Your 7-step playbook Prep: Current SOPs, training matrix, clear RACI. Records: ALCOA+ docs, real-time entries, version control. Methods & Equipment: Validations, IQ/OQ/PQ, calibration logs, standards traceability. Data Integrity: Audit trails, access control, backups, e-signatures, change control. Training & CAPA: Role-based refreshers, tight CAPA timelines. Mock Audit: Risk-based self-inspection, doc room, SME brief, evidence index. Audit Day: One voice, fast retrieval, clean narratives, calm execution. CTA — Get audit-ready now 📚 Build your GMP skills HERE: https://lnkd.in/dK5xJRd2

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✅ Minakem Montreal achieves FDA compliance with ZERO observations! From Sept 15–18, 2025, the FDA confirmed our Lasalle, Quebec site meets all cGMP standards for API manufacturing. This “No Action Indicated” result highlights our unwavering commitment to quality and regulatory excellence and the dedication of our teams ensuring Canadian operations deliver high-quality APIs to patients worldwide. Our site manufactures APIs such as Apixaban, sterile Rilpivirine, Mirabegron, Tofacitinib, and several corticosteroids https://lnkd.in/e4pMFcUi #FDA #cGMP #Pharma #Quality #Minakem

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To comply with Regulation (EC) No 1223/2009, cosmetics must be manufactured under Good Manufacturing Practices (GMP)—and ISO 22716 is your guide. GMP ensures product safety, quality, and regulatory compliance at every step of the manufacturing process. Ready to level up your production standards? Read our blog here: https://hubs.li/Q03j03fw0 #CosmeticsCompliance #ISO22716 #GMP #CosmeticManufacturing #RegulatoryCompliance #RegistrarCorp #CosmeticsSafety

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📢 New Guidance Alert for API Manufacturers! APIC–CEFIC has released the updated Nitrosamines Risk Management Guidance (May 2025) to help API manufacturers align with global regulations (EMA, FDA, Health Canada, etc.). 🔍 Key Highlights: ✔ Expanded risk assessment templates (>11 targeted questions) ✔ Focus on nitrosamine risks from water, solvents, recycled materials, cross-contamination ✔ Aligned with ICH Q9/Q10 and global Q&As ✔ Supplier questionnaire, decision trees, sample templates included 📄 Access the full guidance here: https://lnkd.in/d3VB5vRr #APIs #PharmaManufacturing #NitrosamineRisk #ICHQ9 #GMP #RiskAssessment #PharmaceuticalQuality

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