cGMP Consulting Inc.’s Post

Are you curious about how to prepare for an FDA prior-approval audit? Learn more about the project here - https://lnkd.in/gF8kKe8Q. Check out PSC Biotech Corporation's new project, which details their experience performing a mock audit inspection of a cGMP manufacturing facility. The post highlights the importance of developing audit response plans, corrective action and regulatory compliance plans, and training staff. It also provides valuable insights into the associated cGMP quality systems. #cgmp #qualitysystem #capa #manufacturingexecutionsystem #regulatoryaffairs #fdaapproval 

The Price of Non-Compliance: A cGMP Cautionary Tale This #TransformationTuesday, let's delve into a real-world scenario from the world of regulated manufacturing – a cautionary tale highlighting the high cost of neglecting cGMP (Current Good Manufacturing Practice) standards. Early on in my career, I witnessed a heart-wrenching situation. A pharmaceutical company, facing intense market pressure, overlooked crucial cGMP protocols during production. Our team, their quality assurance partner, raised red flags, but deadlines trumped safety measures. Sadly, our concerns materialized. A critical quality failure emerged, leading to a product recall that jeopardized patient health. This "get it done fast" mentality had devastating consequences. For over a decade, I've dedicated myself to helping regulated manufacturers optimize their quality protocols and ensure strict adherence to cGMP standards. These regulations are the cornerstone of ensuring product safety and efficacy. My expertise lies in pinpointing the root causes of non-compliance and tailoring solutions specific to each situation. Assisting the pharmaceutical company in regaining trust was a lengthy process. We implemented significant changes: strengthening quality control procedures, retraining staff on cGMP protocols, and installing real-time monitoring systems. Every aspect of their operation underwent a transformation, placing compliance at the forefront. Today, the company enjoys renewed trust from patients and healthcare professionals, a testament to their dedication to improvement. While the initial costs of non-compliance were severe, they learned a crucial lesson, becoming a leader in cGMP adherence. Prioritizing safety and quality is paramount. Mistakes can happen, but true leadership lies in recognizing them, swiftly correcting the course, and prioritizing patient well-being above all else. Knowing we helped safeguard patients' health. And that's a mission I'm deeply committed to. Are you a manufacturer struggling with cGMP compliance? We can help! Let's work together to build a culture of cGMP excellence and sustainability in your organization. #cGMP #QualityAssurance #PatientSafety #ManufacturingExcellence

One of the cause of reoccurring NCR is inadequate root cause analysis and a lack of monitoring of CAPA effectiveness.

Key Methods for Checking #CAPA Process ⬇️⬇️🎉🎉💯💯 🔍 #TrendAnalysis: Analyzing CAPA data trends to enhance corrective actions using statistical tools like control charts and Pareto analysis. 🔍 #RootCauseAnalysis: Identifying root causes of non-conformances and implementing corrective actions for lasting solutions. 🔍 #EffectivenessChecks: Ensuring implemented corrective actions effectively address identified issues through follow-up checks. 🔍 #AuditInspection: Conducting audits to assess CAPA process compliance and identify areas for enhancement. 🔍 #RiskAssessment: Evaluating potential impact of issues and effectiveness of corrective actions using risk assessment tools. 🔍 #FeedbackCommunication: Seeking feedback from stakeholders to gauge the effectiveness of CAPA processes. Join me in enhancing pharmaceutical quality with these proven methods! 🌟 #PharmaceuticalQuality #CAPAProcesses #ContinuousImprovement References: - FDA's "Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations" - International Council for Harmonisation's "ICH Q9 Quality Risk Management" - International Organization for Standardization's "ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes"

Absolutely, CAPA is indeed a cornerstone process in pharmaceutical and all manufacturing industries alike. It provides a structured method for identifying, correcting, and preventing issues to maintain quality and compliance standards. For more insights on current trends, job opportunities, and critical processes in the pharmaceutical, biotech, and medical device sectors, be sure to #followus. We're dedicated to keeping you informed and up-to-date on all things relevant to these dynamic industries. #qvalfocus #CAPA #beginnersread

The Good Manufacturing Practice (GMP) audit is among the most critical aspect of an organization’s ability to manufacture and distribute a regulated product. GMP Auditor course is specifically designed to address the challenges of auditing for the pharmaceutical industry and help auditor to effectively perform their assigned responsibilities. By following best practices, one can be sure that the organization’s next GMP audit will goes smoothly and be more confident in the state of compliance. Our course will cover the importance of GMP, GxP compliance. Audit preparation, Audit report writing, Role of ICH Q7, Q8, Q9, Q10 in pharma industry, ISO 9001: 2015 and GMP requirements, ISO 19011: 2018, 21 CFR part 11, Computer system validation and GAMP5. For more information, please contact us on 9819125208/9821144706 Email: rajashrio@gmail.com, raajgprac@gmail.com Visit our website at https://lnkd.in/fkFqfeF #raajgprac #elearning #pharma #medicaldevice #nutraceutical #cosmetics #GMP #audit #qualityassurance #qualitymanagement #riskmanagement #compliance   #regulatoryaffairs #formulation #API  #documentation #CSV #GAMP5

The #FDA issued the #QualityManagementSystem Regulation (#QMSR) Final Rule to amend the device current #goodmanufacturingpractice (#CGMP) requirements of the Quality System (#QS) regulation (#21CFR820), incorporating by reference the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), #ISO13485:2016 #Medicaldevices – Quality management systems – Requirements for #regulatory purposes. This final rule is the latest action taken by the FDA to promote consistency in the regulation of devices. This action will harmonize the FDA’s CGMP regulatory framework with that used by other #regulatory authorities. The rule is effective February 2, 2026, two years after publication. Until then, manufacturers are required to comply with the QS regulation. #IVD

The Good Manufacturing Practice (GMP) audit is among the most critical aspect of an organization’s ability to manufacture and distribute a regulated product.   GMP Auditor course is specifically designed to address the challenges of auditing for the pharmaceutical industry and help auditor to effectively perform their assigned responsibilities. By following best practices, one can be sure that the organization’s next GMP audit will goes smoothly and be more confident in the state of compliance. Our course will cover the importance of GMP, GxP compliance. Audit preparation, Audit report writing, Role of ICH Q7, Q8, Q9, Q10 in pharma industry, ISO 9001: 2015 and GMP requirements, ISO 19011: 2018, 21 CFR part 11, Computer system validation and GAMP5. For more information, please contact us on 9819125208/9821144706 Email: rajashrio@gmail.com, raajgprac@gmail.com Visit our website at https://lnkd.in/fhS2z8y   #raajgprac #elearning #pharma #medicaldevice #nutraceutical #cosmetics #GMP #audit #qualityassurance #qualitymanagement #riskmanagement #compliance   #regulatoryaffairs #formulation #API  #documentation #CSV #GAMP5

Are you curious about how to prepare for an FDA prior-approval audit? Learn more about the new project by PSC Biotech Corporation here - https://lnkd.in/gs_B-ggV #cgmp #qualitysystem #capa #manufacturingexecutionsystem #regulatoryaffairs #fdaapproval FDA

The Good Manufacturing Practice (GMP) audit is among the most critical aspect of an organization’s ability to manufacture and distribute a regulated product.   GMP Auditor course is specifically designed to address the challenges of auditing for the pharmaceutical industry and help auditor to effectively perform their assigned responsibilities. By following best practices, one can be sure that the organization’s next GMP audit will goes smoothly and be more confident in the state of compliance. Our course will cover the importance of GMP, GxP compliance. Audit preparation, Audit report writing, Role of ICH Q7, Q8, Q9, Q10 in pharma industry, ISO 9001: 2015 and GMP requirements, ISO 19011: 2018, 21 CFR part 11, Computer system validation and GAMP5. For more information, please contact us on 9819125208/9821144706 Email: rajashrio@gmail.com, raajgprac@gmail.com Visit our website at https://lnkd.in/fhS2z8y   #raajgprac #elearning #pharma #medicaldevice #nutraceutical #cosmetics #GMP #audit #qualityassurance #qualitymanagement #riskmanagement #compliance   #regulatoryaffairs #formulation #API  #documentation #CSV #GAMP5