cGMP Consulting Inc.’s Post

Quality management system discussions, posts, articles, and examples are not just shared on social media and in magazines. They are crucial conversations that help to shape the pharmaceutical industry. One of the points I discussed during my CPHI presentation on “Difficulties Meeting US FDA Regulatory Requirements” was the FDA’s perspective on Quality Maturity and my takeaway. I discussed the following. Level 1: Disconnected Management: When the senior management is surprised that they have received a US FDA 483 warning letter, recall, injunction, consent decree, etc., consider your company’s maturity at level 1. Level 2: Fire Fighting Mode—Duct Tape Approach: Is your company always in fire-fighting mode, solving problems with good intentions but using a duct tape approach to solving CGMP? Level 4: Vigilant Quality Culture Fully institutionalized (Experience + Knowledge + Innovation + Improvements at all levels) means personnel in your company at all levels are well versed with procedural (SOPs) and regulatory knowledge (21 CFR Part 211). They will be able to identify, document, and resolve any CGMP issue as written in the company’s internal procedures, which are entirely in line with and associated with the US FDA's CGMP requirements. For example, all personnel in the Warehouse know the details of all SOPs and CGMP requirements (as per 21 CFR Part 211.142, 211.150, 211.100, 211.25, Sub Part J, and 21 CFR Part 7 for recall) and review them when there is any question or doubt on the procedure. Vigilant Quality Culture: Senior management is fully engaged. Management reinforces and rewards for identifying, thoroughly investigating, and resolving any regulatory issues identified at any level in the Company. #usfda #eugmp #CGMP #compliance #pharmaceuticalindustry #drugmanufacturing #biotechnology #cellandgenetherapy #qualityassurance #qualitymanagementsystems #alcoa #dataintegrity #cgmpcompliance

Unlock the Power of Compliance: Partner with cGMP Consulting in 6 Simple Steps Understanding the complexities of Good Manufacturing Practice (GMP) regulations can be daunting, but with the right partner, it doesn’t have to be.     Here’s a quick look at the six key steps in our partnership process. Are you ready to elevate your operations?  Reach out now at https://lnkd.in/gxMJ6iBS for a free consultation.    #cGMP #GMPCompliance #QualityAssurance #RegulatoryCompliance #ManufacturingExcellence #CompliancePartner #OperationalExcellence

Is this a Quality Management System (QMS) Design process? 1: Why to reinvent the wheel? 2: Why can’t we use the best out of different examples already available from different sources? 3: I saw a nice article and I think we should use it. 4: In my past experiences, we did this way. 5: I saw an example of QMS on social media, we just need to tweak it to match our requirements. 6: Regulations are interpretative no need to waste time on it. 7: I could not find it in the regulations, Let's keep the procedure from the example already available. 8: Let’s take the best out of these examples, we build a better-quality Manual. 9: We will improve QMS in our periodic review process. 10: If it is not in regulation, refer to the guideline. Are these Quality Management System Elements? 1: Continuous Improvement 2: Quality by Design: Built-in Quality for Patient Safety 3: Risk Assessment 4: Computerized systems to eliminate human error 5: Deviations, Change Management, and CAPA 6: Hundreds of Procedures 7: Empowering workforce 8: Cross-functional teams 9: Work as a team to implement QMS 10: Implement QMS at all levels in the CGMP operations Are these elements effective? US FDA Pharmaceutical Drug CGMP 483 Observation Trending (2006-2023): Posting Link: (https://lnkd.in/eUb6-Kw8). What Quality Elements are required by the US FDA? CGMP Post Link: https://lnkd.in/erWrfSgb    #usfda #eugmp #CGMP #compliance #pharmaceuticalindustry #drugmanufacturing #biotechnology #cellandgenetherapy #qualityassurance #qualitymanagementsystems #alcoa #dataintegrity #cgmpcompliance

🌟 Let’s Discover the Features of Paperless GMP! 🌟 Embrace the Next Generation of PaperLess GMP with our End-to End Paperless Solution! 📱💻 In today’s Rapidly Evolving Manufacturing Landscape, embracing Digital Transformation isn’t just a Choice - It’s a Necessity. 🚀 Transitioning to PaperLess GMP is not only about Reducing Paper Usage but about unlocking unparalleled efficiency and compliance benefits. Unlike any other software, Our Comprehensive QMS-enabled GMP Software offers unparalleled solutions for the Pharmaceutical Industry. Join the PaperLess revolution and elevate your GMP processes to new heights of efficiency and compliance. 🌐📈 Contact us for more information. 📞 7611000550 / 7722000550 📧 info@cyclonepharma.com/ megha@paperlessgmp.com Megha Ganage Vaishnavi Pannase Sagar Sakhare   #PaperlessGMP #DigitalTransformation #ManufacturingExcellence #Efficiency #Compliance #Sustainability #FutureOfWork #cGMP #PharmaSoftware #PharmaQuality #eBMR #RegulatoryCompliance #PharmaInnovation

Simplifying Compliance For those searching for the terms "Disaster Recovery" or "Business Continuity" within 21 CFR Part 211, it's important to note that these specific terms are not mentioned in the regulations. Nonetheless, the requirements for disaster recovery and business continuity are encompassed in 21 CFR Part 211.68(b). This section mandates complete backup solutions for disaster recovery and using an alternative system if the primary system fails for business continuity. The US FDA 21 CFR Part 211 are regulations and NOT cGMP guidelines. 21 CFR Parts 210 and 211 are "Current Good Manufacturing Practice" (CGMP) regulations, although the industry often interprets them as cGMP guidelines. Opinion: The prevailing belief that the US FDA regulations are interpretative leads the industry to persist with practices that often result in violations of US FDA CGMP. These different terminologies led to this interpretation, significantly influencing compliance with US FDA CGMP requirements. For example, Regulatory Requirements, Guidelines, and Standards are frequently used as if they are synonymous. Regulations are mandatory, whereas guidelines and standards are optional. The US FDA, ICH, WHO, or PIC/s guidelines may be adopted as needed, but the US FDA regulatory requirements are obligatory. The same principle applies to the terms 'Disaster Recovery' and 'Business Continuity,' which often result in extensive processes and documentation rather than the comprehensive backup recovery and alternative system stipulated in the final sentence of 21 CFR Part 211.68(b). Employing the terminology from the regulations could streamline the implementation process and limit the scope of interpretations. See the post on the consistent US FDA 483 observations. POST LINK: https://lnkd.in/eem2vDg2   Instead of merely chasing guidelines, adherence to regulatory requirements is vital to avoid the US FDA CGMP 483 observations, warning letter or other severe, expensive consequences. #usfda #eugmp #CGMP #compliance #pharmaceuticalindustry #drugmanufacturing #biotechnology #cellandgenetherapy #qualityassurance #qualitymanagementsystems #alcoa #dataintegrity #cgmpcompliance #Indiapharmaceutical

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🔍✨ Elevate your standards with VaLogic GxP Consulting! 🚀 Seamless Compliance, Superior Results: VaLogic GxP Consulting is your trusted partner in navigating the complex landscape of Life Sciences regulations. Our expertise extends across critical services. Learn more here: https://lnkd.in/ewknW--R 1️⃣ Design Advisement: Tailoring your approach from the ground up, ensuring compliance is seamlessly woven into the fabric of your operations. We bring precision to the drawing board! ➡️ Services include: Facilities Clean Rooms Temp & RH Rooms Quality Systems Risk-based Validation 2️⃣ cGMP Execution: Impeccable adherence to Current Good Manufacturing Practices (cGMP) is the hallmark of our services. We don't just meet standards; we set them. ➡️ Services include: CQV Services Equipment Management Facility Monitoring Quality Management Calibration Validation CMC Regulatory Submissions 3️⃣ Facility Maintenance: A well-maintained facility is a compliant facility. Our meticulous approach ensures your operations run smoothly while staying in line with regulatory requirements. ➡️ Services include: Inspection Readiness Contamination Control Risk Management Maintenance Troubleshooting At VaLogic, we comprehend the crucial intersection of precision and compliance. Our GxP Consulting services surpass mere compliance and aim for excellence in every single detail. If you want to succeed with VaLogic GxP Consulting, please get in touch with us today. With our services, you can experience the synergy of seamless compliance and superior results. 💼🌟 #biotech #consulting #maryland #pharmaceutical  

Is your pharmaceutical organization ready for its next #audit❓ Don’t let document management challenges or compliance gaps slow you down. Join us at Digital CQV 2024 powered by No deviation in partnership with Kneat Solutions for a deep dive into Audit Readiness Using #Kneat, where we’ll discuss strategies to streamline audit preparation and ensure full compliance with regulatory requirements.   📅 Event: Digital CQV 2024  💡 Topic: Audit Readiness Using Kneat Learn how to implement digital tools like Kneat to enhance your audit readiness, reduce risk, and simplify the #validation process. Stay ahead of regulatory demands with a paperless solution that brings efficiency and compliance into one platform. Register now to grab your 𝐞𝐚𝐫𝐥𝐲 𝐛𝐢𝐫𝐝 𝐝𝐢𝐬𝐜𝐨𝐮𝐧𝐭 and secure your spot at this groundbreaking event. Don’t miss this chance to explore the future of validation technology and ensure compliance with FDA, EMA, and PIC/S regulatory standards. 𝐓𝐨 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫: https://wkf.ms/3ZmnSD8 For more information: 🌐 https://lnkd.in/gU9SvuCh or 📧 event@nodeviation.com #DigitalCQV2024 #AuditReadiness #Kneat #Compliance #PharmaSolutions #PaperlessValidation #PharmaceuticalIndustry #NdCulture #NdTeam #Nodeviation

🥁Executives and leaders of pharma manufacturers this post is for you🥁 💡Looking for an industry-specific paperless manufacturing solution? Our GMP compliant Digital Logbook can: 🚀Boost productivity🚀  ♻️Enhance corporate sustainability♻️  ✅️And reduce the risk of receiving FDA warnings✅️ To learn more click the link below👇  https://lnkd.in/dvnFXzBP #pharmaceuticalmanufacturing #paperlessmanufacturing #digitaltransformation #FDA #GMP #quality #sustainability #productivity #SCWAI #DigitalFactory #paperlessfactory #electroniclogbook #digitallogbook #digitalforms #eforms #paperlessforms #automatedforms #digitalworkflow #sustainablemanufacturing #manufacturing #efficiency #sustainability #Industry40 #ManufacturingTech #SmartFactory #PharmaceuticalManufacturing #Pharma #PharmaInnovation #PharmaTech #PharmaFuture

💠 Why are Quality Metrics Important❓ The minimum standard for ensuring that a manufacturer’s products are safe, effective and of sufficient #quality is compliance with current good manufacturing practice (#CGMP) requirements. ‼️CGMP compliance alone, however, does not indicate whether a manufacturer is investing in improvements and striving for sustainable compliance, which is the state of having consistent control over #manufacturingperformance and quality. #Sustainablecompliance is difficult to achieve without a focus on continual improvement. 👀 An effective #PharmaceuticalQualitySystem (#PQS) ensures both sustainable compliance and #supplychainrobustness. 👀‼️Quality metrics can contribute to a manufacturer’s ability to develop an effective PQS because these data provide insight into manufacturing performance and enable the identification of opportunities for updates and #innovation to manufacturing practices. 👀‼️Quality metrics also play an important role in supplier selection and can inform the oversight of #contractactivities and #materialsuppliers, as well as help determine appropriate monitoring activities to minimize #supplychaindisruptions. ‼️Quality metrics data from establishments can also have utility to the FDA. ✅Assist in developing #compliance and #inspectionpolicies and practices. ✅Improve #prediction and possibly mitigation of future drug shortages, while encouraging the pharmaceutical industry to implement innovative quality management systems for manufacturing. ✅ Enhance FDA’s risk-based #inspectionscheduling, reducing the frequency and/or length of routine surveillance inspections for establishments with quality metrics that suggest sustainable compliance. ✅ Provide ongoing insight into an establishment’s operations between inspections.