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#FDA-Wednesday: Questions and Answers on cGMP Regulations | Production and Process Controls How up to date are you on the FDA's draft guidance? Stay Informed on FDA's Latest Good Manufacturing Practice Regulations! The FDA has recently published vital Q&A addressing Current Good Manufacturing Practice (#cGMP) regulations concerning drug production and process controls. At Compliance Group Inc, as experts in compliance, we recognize the crucial importance of adhering to cGMP standards in drug manufacturing. Our team is dedicated to assisting manufacturers in upholding the highest quality standards and ensuring robust regulatory compliance. Visit us at https://lnkd.in/gXZQ-cHc Please send your questions to info@complianceg.com #fda #cgmp #fdawednesday #fdacompliance #quality #fdadraftguidance #regulatory #compliance #drugmanufacturing #compliancegroupservices #healthcare #medicaldevicecompliance #fdaregulations #medicaltechnology Explore and stay updated: https://lnkd.in/gXZz4KQn

Are you encountering challenges adhering to cGMP regulations within your life sciences organization? If so, there are many effective approaches you can use to help you stay on track. 📈 💡 Here are some effective strategies to help you: - Training: Educate employees on cGMP requirements. - Documentation: Maintain detailed records of processes. - Equipment Compliance: Regularly validate equipment and facilities. - Compliance Culture: Foster a culture prioritizing compliance. - Supplier Management: Choose compliant suppliers and monitor processes. - Audits and Inspections: Conduct regular audits and be prepared for inspections. - Non-Compliance Response: Develop and implement corrective action plans. - Regulatory Updates: Stay informed about changes in cGMP regulations. 👓 Read the full article, "Strategies for Achieving cGMP Compliance Across the Life Sciences Industry," at https://eleap.me/4a8DQ5N to implement these strategies and ensure compliance and risk management. #eLeaP #cGMP #LifeSciences #Compliance #RiskManagement Please feel free to share your thoughts or strategies below. Let's start a discussion!

CGMP software helps automate and standardize processes to get to market faster. GMP quality systems connect and ensure quality throughout the product life cycle. Information is maintained in a central location. Compliance is simple. Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system. The U.S. Food and Drug Administration's (FDA) Current Good Manufacturing Practices (CGMPs) require proof of proper handling for every step of the production process. Batch records and other types of manufacturing documentation demonstrate this level of accountability. Paper-based systems are cumbersome and error-prone. The right electronic batch record (EBR) software system removes the documentation burden from quality and manufacturing teams. It also improves product quality and key performance metrics. MasterControl

The FDA recently released a warning letter sent to a China-based pharma firm, finding the company failed at multiple levels to ensure its CGMP records were accurate. The warning letter was sent earlier in July and followed a very critical Form 483 (https://lnkd.in/g4Zi4b4T) that showed how the agency’s nine-day site inspection documented “serious quality assurance (QA) deficiencies.” 📄 Read the full warning letter: https://lnkd.in/gJXkn_CG We broke down that 483 a few weeks ago, which saw a ton of eyeballs from across the industry: https://lnkd.in/g78UdW3A As reported by Endpoints News (https://lnkd.in/ggK6Ga_6), the firm's website indicates a licensing agreement with a major manufacturer and a potential $6B deal with a US startup for a GLP-1 portfolio. A few of the most egregious lines from the subsequent warning letter include: • "Discarded original CGMP records found stacked in a bag underneath a vehicle and in a nearby trash can." • "Production manager’s unrestricted access to blank production batch records and other CGMP documents without QA issuance." • "Employees creating new records to correct errors and discarding old records, with no assurance that archived data is original or accurate." • "Production manager printed a blank copy and had the employee transcribe the information on the new record and discarded the old record." Some other deficiencies from the warning letter: 🚩 Facility design flaws: Poor separation and airflow management in aseptic processing areas, risking contamination. 🚩 Data integrity concerns: Significant lapses in ensuring accurate and complete data records. 🚩 Insufficient remediation: Inadequate responses and risk assessments to address identified issues. ——— A few lessons here: ▪ Always restrict access to blank production records and ensure all document handling is managed by the QA department. Implement and enforce strict procedures for document destruction and data integrity. ▪ Always conduct thorough and dynamic smoke studies to evaluate airflow patterns in aseptic processing areas. Use these studies to validate physical barriers and airflow controls. ▪ Make sure your environmental monitoring protocols include non-viable particle monitoring and the use of pre-paginated logbooks for recording data. ▪ Develop and execute a risk assessment plan that includes evaluations of human interactions, equipment placement, air quality, and facility layout in aseptic processing areas. ——— Want to stay out of our warning letter breakdowns? Contact us to access our global network of 2,500+ consultants, 225+ of whom are former FDA. We run audits, mock inspections, and remediation for 17 of the top 25 life science firms. #fda

Meeting CGMP Regulations to Minimize Contamination in Life Science Research Read the article here - https://lnkd.in/eKf4z5RE #LifeScienceRegulations #CGMPGuidelines #ManufacturingPractices #RegulatoryCompliance #PharmaceuticalManufacturing #QualityControl #FDACompliance

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

🔬 Get Ready for a Deep Dive into GMP Compliance! 🔬 We are excited to invite you to an exclusive LinkedIn Live Introduction Interview with James Drinkwater on September 9th at 11:00 AM EST! James, an expert in GMP compliance, will share insights on the upcoming masterclass titled "Annex 1 GMP Compliance - Exploring 15 Key Topics with High Impact in 2024." 🌟 In this session, you’ll get a firsthand look at the critical topics that will be covered, including: Protective Airflows and Contamination Control Annex 1 Compliant Contamination Control Strategies (CCS) Rapid Micro Methods (RMM) and Data Integrity Barrier Glove Management and Aseptic-Containment Strategies And much more! Join us to learn about the paradigm shift in GMP regulations and how to navigate the new challenges in sterile product manufacturing. This session is perfect for professionals in QA, QC, production operations, engineering, and more. 📅 Save the date: September 9th, 2024, at 11:00 AM EST. 📢 Don’t miss out on this opportunity to gain valuable insights and ask your burning questions in our interactive Q&A session! #LinkedInLive #GMPCompliance #Annex1 #Pharmaceuticals #Biotech #MetamorphGlobal #ProfessionalDevelopment

🔍 Root Cause Analysis in Good Manufacturing Practices (GMP) 🔍 In the pharmaceutical industry, ensuring the highest standards of product quality and patient safety is paramount. One essential tool in achieving this is Root Cause Analysis (RCA). RCA is a systematic process used to identify the underlying causes of deviations and non-conformances within GMP environments. By understanding the root causes, we can implement effective corrective and preventive actions (CAPA) to prevent recurrence. Key steps in RCA include: Data Collection: Gather relevant data and evidence. Problem Definition: Clearly define the problem or deviation. Root Cause Identification: Use techniques like the 5 Whys, Fishbone Diagram, or Fault Tree Analysis. Implementing Solutions: Develop and implement CAPA based on the identified root causes. Monitoring and Verification: Ensure the effectiveness of the actions taken and make adjustments as needed. Integrating RCA into GMP processes not only helps in compliance but also fosters a culture of continuous improvement, ultimately leading to safer and more reliable products. #Pharmaceuticals #GMP #RootCauseAnalysis #QualityControl #QualityAssurance #PatientSafety #ContinuousImprovement #CAPA #PharmaIndustry

Gain expertise in the updated AAMI TIR48:2024 for Combination Products through AAMI Training! Key Updates: AAMI TIR48:2024 – QMS Recommendations for Combo Products 📅 May 9 | 1:00 pm - 4:00 pm ET | Virtual AAMI TIR48:2024 reflects changes in regulations and guidance for applying the US FDA cGMP Final Rule on #CombinationProducts. This training provides insights and best practices for understanding and applying Combination Products cGMP expectations, aiding informed decision-making. Topics include key terminology, examples, and considerations for a "Streamlined Approach" and Inspection Readiness. Presenter:  Susan Neadle, Principal Consultant & President, Combination Products Consulting Services LLC Learn more here: https://lnkd.in/e6_drPgP #AAMITraining #Compliance #RegulatoryCompliance #MedicalDevices

Webinar recording about the Latest Updates in Global GMP, if you are interested and missed this.