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Ensure the integrity of your life sciences operations. Proper validation safeguards against costly delays, regulatory non-compliance, and potential product recalls. Discover our reliable validation solutions today. #lifesciences #validation #compliance #regulatory #qualityassurance

𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐂𝐀𝐏𝐀 𝐚𝐧𝐝 𝐢𝐭'𝐬 𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧��𝐚𝐭𝐢𝐨𝐧... "Insufficient CAPA procedures & its implementation" has consistently topped the list of most common FDA inspectional observations.. ""FY-2020 To 2023 total 198 Observations are related to CAPA system"". Delay in implementation of CAPA will be impact on quality systems and there will be chances of reoccurrence of non conformance. "The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence" Note: The ideas, views and opinions expressed in my LinkedIn posts represent my own views and based on current regulatory inpsections and outcome, and not related to any of my current or previous Organization. #capa #learning #pharma #qms #innovation

How to develop & manage robust Quality Matrix? ·  ·  Developing & managing a robust Quality Matrix to meet regulatory requirements requires careful attention to detail, adherence to stringent standards, and a focus on patient safety. Here's a tailored guide for the same: 1. Understand Regulatory Landscapes: Familiarize yourself with regulatory bodies governing the pharmaceutical industry such as the US FDA , EMA (in Europe), and other regional regulatory authorities. Understand relevant regulations and guidelines such as GMP, GCP, and GLP. 2. Identify Critical Quality Metrics: Determine key quality metrics specific to the pharma industry. These may include product quality attributes, manufacturing process parameters, compliance with pharmacopeial standards, adverse event reporting, and adherence to regulatory submission timelines. 3. Define Quality Objectives: Establish quality objectives aligned with regulatory requirements. Objectives should focus on ensuring product efficacy, safety, and compliance with regulatory standards. 4. Create a Quality Matrix Framework: Develop a structured Quality Matrix framework. Include sections for critical quality attributes, manufacturing processes, analytical methods, documentation requirements & regulatory compliance. Ensure clarity on roles, responsibilities & escalation procedures. 5. Implement Risk-Based Approach: Utilize a risk-based approach to prioritize quality activities & allocate resources effectively. Identify high-risk areas in the product lifecycle such as formulation development, manufacturing, packaging & distribution. Focus quality efforts on mitigating risks. 6. Utilize QMS: Implement a robust QMS to manage documentation, deviations, CAPA, change controls & other quality-related processes. Ensure the QMS complies with regulatory requirements & facilitates traceability & accountability. 7. Ensure Supplier Quality Management: Establish procedures for evaluating & monitoring the quality of raw materials, APIs, and third-party suppliers. Conduct supplier audits, qualification assessments & ongoing monitoring to ensure compliance with regulatory standards & product quality requirements. 8. Implement Validation & Qualification: Validate critical processes, equipment, analytical methods & computer systems in accordance with regulatory guidelines such as ICH Q7, Q8, Q9, and Q10. Ensure thorough documentation to demonstrate compliance with regulatory requirements. 9. Maintain Data Integrity: Implement measures to ensure the integrity, accuracy, and reliability of data generated throughout the product lifecycle. Adhere to principles of ALCOA + & implement controls to prevent data manipulation or falsification. 10. Conduct Regulatory Compliance Audits: Regularly conduct internal audits to assess compliance with regulatory requirements, quality standards & established procedures. By following these tailored steps, you can develop & manage a robust Quality Matrix. #qualitymatrix #compliance

To ensure quality and GMP compliance, manufacturers rely on alarm notification systems. These systems provide proof of successful campaigns by ensuring there are no critical alarms related to critical quality data. That’s why an alarm notification system is an important tool for quality assurance.   https://lnkd.in/gSqc_crS

Great article. Run operations as if the FDA is always inpecting so when they arrive all work goes as normal. A company that increases worplace stress when the FDA is a key sign that there are problems. Lastly, companies that are inspected often should have staff to absorbs the visit so work can continue as normal. Have you worked somewhere where all operations halt when they are visited? Another sign of missmanagement.

⌚ In recent years, the CGMP manufacturing industry has experienced a significant shift in FDA inspection dynamics. At the height of the pandemic in FY2021, FDA conducted 7,147 onsite domestic inspections and 186 foreign inspections. In FY 2022, this grew to 12,203 domestic and 907 foreign inspections, and in FY 2023, increased to 13,305 domestic inspections and 2,716 foreign inspections. The COVID-19 pandemic and the subsequent increase in remote work resulted in a lull in on-site FDA inspections. While this has offered some breathing room, it's crucial to remember that inspection readiness is not a one-time event but a continuous state of preparedness. As manufacturing sites start to see a resurgence of in-person inspections, staying ready is more important than ever. 🤔 So what does it mean to be "inspection ready" at all times? It implies that the facility maintains a CONSISTENT state of compliance with all regulatory requirements, quality standards, and internal processes. Essentially, you are prepared to undergo an FDA inspection without the need for last-minute adjustments or panic. Here are 3 simple strategies to help: *Regular Internal Audits: Conducting regular internal audits can help identify potential issues before the FDA does. These audits should be thorough and mimic FDA inspections to ensure nothing is overlooked. Include individuals from level 1 operators to senior leadership. *Robust Documentation Practices: Ensure all records are up-to-date and easily accessible. Good documentation practices are the backbone of inspection readiness, providing clear evidence of compliance. Some of the commonly requested documents include, but are not limited to the following: Site Master File, Organization Chart (up to Operator or Analyst level), SOP Master Index, List of products, Training procedure, Recall procedure, Batch numbering procedure, List of deviations, change controls, OOS, complaints investigations and CAPAs since the last inspection, Responses and CAPAs to prior FDA 483 Observations *Training and Education: Continuous training for all staff members on current regulations and best practices is essential. This not only keeps everyone informed but also instills a culture of quality and compliance. What are some of your strategies to stay "inspection ready?" #manufacturing #fda #inspectionreadiness

📣 FDA Audits: What You Need to Know 📣 When the FDA knocks, you better be ready. Here’s how their audit process works and how you can stay ahead: 1. It starts with a notification: Usually, you’ll get a heads-up.   But sometimes? Surprise inspection.   Always be prepared. Don’t wait for the call. 2. Document review: FDA will dig into your records first.   They want to see everything: Batch records, SOPs, CAPAs.   Make sure your documentation is airtight and up-to-date. 3. Facility inspection: Next, they’ll tour your facility.   Cleanliness, equipment, processes, it’s all under the microscope.   Ensure your site is inspection-ready 24 by 7. 4. Interviews with key personnel: They’ll talk to your team. From operators to quality managers, everyone needs to know their stuff.   Training is key. Don’t leave anyone anytime unprepared. 5. Exit meeting: After the audit, the FDA will discuss findings with you.   This is your chance to clarify and correct on the spot.   Take it seriously. It can save you from major headaches later. 6. Follow-up actions: If issues are found, you’ll get a Form 483 or Warning Letter.   Respond quickly and thoroughly.   Show the FDA that you’re committed to compliance. ☑ FDA audits aren’t just about qualifying. They’re about proving your commitment to quality ✅ #FDAAudit #PharmaQuality #RegulatoryCompliance #PharmaManufacturing #QualityAssurance #GMP #PharmaIndustry #FDACompliance #PharmaLeadership #Pharmaceuticals #AuditReady #PharmaRegulations

Thanks Jerry Chapman after reading your article on FDA Inspection Shows Systemic Data Falsification Issues [ https://lnkd.in/gZQ_zFqS] I think this image can be suitable. Quality assurance (QA) should operate independently from other departments to avoid conflicts of interest and ensure unbiased oversight. An independent QA structure allows for effective risk management and adherence to quality standards without external pressures from production or finance teams. This autonomy fosters a culture of quality, where all employees recognize their role in maintaining standards. Moreover, independent QA teams can align their goals with customer needs rather than internal departmental objectives, enhancing overall product quality and reliability. Quality assurance (QA) is responsible for encompass a range of activities aimed at ensuring products meet regulatory and quality standards. Key responsibilities (but not limited to) include; Developing QA Policies: Establishing and implementing quality assurance policies and procedures to guide operations. Conducting Inspections: Performing routine inspections and quality tests to monitor compliance with established standards. Documentation Oversight: Maintaining accurate records of quality assurance activities, including audits and corrective actions. Training and Development: Providing training for employees on quality standards and procedures to ensure compliance. Continuous Improvement: Identifying areas for improvement and implementing changes to enhance product quality and operational efficiency. #dataintegrity #alcoa #compliance #pharmaceutical #fda #knowledgesharing #inspection #gmp #learning #Audit #quality #healthcare #innovation #drugs

𝙃𝙤𝙬 𝙩𝙤 𝙧𝙚𝙫𝙞𝙚𝙬 𝙖 𝙨𝙥𝙚𝙘𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣 𝙖𝙨 𝙖 𝙧𝙚𝙜𝙪𝙡𝙖𝙩𝙤𝙧𝙮 𝙖𝙛𝙛𝙖𝙞𝙧𝙨 𝙥𝙧𝙤𝙛𝙛𝙚𝙨𝙞𝙤𝙣𝙖𝙡 Understand Regulatory Requirements: Familiarize yourself with the regulatory framework governing the product or industry. This could include FDA regulations, EU directives, or other relevant standards. Review the Scope: Understand the scope of the specification document. Ensure it covers all relevant aspects of the product, including its intended use, composition, manufacturing process, and quality standards. Verify Compliance: Check if the specification complies with regulatory requirements and industry standards. This includes ensuring that the product meets safety, efficacy, and quality standards set by regulatory authorities. Assess Clarity and Completeness: Ensure that the specification is clear, concise, and complete. It should leave no room for ambiguity or misinterpretation. All critical parameters and requirements should be clearly defined. Evaluate Manufacturing Processes: Assess whether the manufacturing processes outlined in the specification comply with Good Manufacturing Practices (GMP) and other relevant regulations. Verify that the processes are capable of consistently producing a product that meets quality standards. Check for Validation Requirements: Determine if the specification includes requirements for validation studies, such as analytical method validation, process validation, or stability studies. Ensure that these studies are conducted in accordance with regulatory guidelines. Assess Risk Management: Evaluate whether the specification addresses potential risks associated with the product or manufacturing process. Ensure that appropriate risk management measures are in place to mitigate these risks. Verify Labeling and Packaging Requirements: Ensure that the specification includes accurate labeling and packaging requirements in compliance with regulatory standards. This includes labeling requirements for product identification, usage instructions, warnings, and precautions. Document Review: Maintain thorough documentation of the review process, including any findings, comments, or recommendations. Document any deviations from regulatory requirements and propose corrective actions as needed. Collaborate with Stakeholders: Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and legal, to ensure alignment and consensus on the specification requirements. Stay Updated: Continuously monitor changes in regulatory requirements and industry standards. Update specifications as necessary to ensure ongoing compliance. #regulatoryaffairs #regulatory #regulatorysubmission #regulatoryfilling #regulatorycomplaince #regulatorystrategy #regulatoryscience #Dossier #CMC #specification #pharmaceuticalcompaines #CTD #ACTD

🌟 Medical Device Manufacturers - Are You Prepared for the Regulatory and Quality Challenges Ahead? 🌟 In the rapidly evolving medical device landscape, staying ahead of regulatory challenges is more critical than ever. Three key Regulatory Affairs (RA) and Quality Assurance (QA) hurdles are at the forefront: 1. Navigating Complex Global Regulatory Landscapes: With evolving regulations across regions like the EU (MDR/IVDR), North America (FDA QMSR), and Asia, ensuring compliance while managing global market entry can be daunting. 2. FDA/EPA Compliance and Environmental Regulations: The recent EPA rule on ethylene oxide (EtO) emissions and stringent FDA requirements for sterility and environmental safety are pushing manufacturers to re-evaluate their processes. Non-compliance risks product delays, shortages, and severe penalties. 3. Effective Risk Management & Mitigation: From addressing potential post-market surveillance issues to adapting to new safety standards, managing risk efficiently is crucial to avoid recalls and ensure product success. 🔍 Why RQM+ Is Your Only Solution: At RQM+, we don’t just offer regulatory and quality assurance services - we provide strategic partnership. Our deep expertise ensures seamless navigation through complex regulations, our focus on RA/QA compliance keeps you aligned with the latest standards, and our proactive risk management approach minimizes disruptions. Partner with us to turn your challenges into opportunities for growth. 📞 Let’s discuss how RQM+ can be your trusted partner in overcoming these challenges. Connect with us today to start the conversation! 👉 https://lnkd.in/e7wxN59w #MedicalDevices #RAQA #RegulatoryCompliance #RiskManagement #EnvironmentalRegulations #RQMPlus