Pharmalliance Consulting Ltd’s Post

Effective CCS governance ensures meticulous control and escalation processes! 🌐 Key components of a governing body include: 🔬 Expertise in microbiology and process management. 📅 Responsibility for regular assessments to maintain standards. 🚨 Authority to address adverse trends swiftly. 🚀 Clear pathways for seamless escalation. Let's empower our governance structure to uphold excellence in control and compliance! 💪 #CCSGovernance #QualityAssurance #ContaminationControl #ProcessManagement

🚨 It's Warning Letter Wednesday 🚨 This time we focus on a drug manufacturer based in the U.S., which received a Warning Letter on January 25th, 2024... Violations include: 1️⃣ Failure to Conduct Component Identity Testing The company failed to conduct at least one test to verify the identity of each component of a drug product before use, and failed to establish the reliability of supplier certificate of analysis (COA) results at appropriate intervals. This violates 21 CFR 211.84(d)(1) and (d)(2). 💡Corrective Actions - Conduct a comprehensive review of the material system to ensure all suppliers of components, containers, and closures are qualified. - Establish adequate procedures for testing and release of each incoming batch of components. - Implement a validation program for supplier COAs and specify methods for confirming supplier results. 2️⃣ Lack of Written Procedures for Production Control The company failed to establish written procedures for production and process control to ensure drug products have the identity, strength, quality, and purity they purport or are represented to possess. This violates 21 CFR 211.100(a). 💡Corrective Actions - Develop and implement procedures for process performance qualification (PPQ) and ongoing process monitoring. - Provide a timeline for PPQ completion for all marketed drug products. 3️⃣ Inadequate Oversight by the Quality Control Unit (QU) The QU did not adequately ensure drug products complied with CGMP and met established specifications for identity, strength, quality, and purity. This violates 21 CFR 211.22. 💡Corrective Actions - Conduct a comprehensive assessment of QU procedures and resources. - Enhance QU oversight throughout manufacturing operations. - Implement training programs to ensure employees are adequately trained in CGMP requirements. 💡Immediate Steps to be Taken ✅ Engage an independent third-party consultant to perform a comprehensive audit and assist in remediation efforts. ✅ Develop a detailed plan with timelines to address each violation and proposed corrective actions. ✅ Suspend manufacturing of drug products until procedures are validated and adequate oversight is ensured. These actions are critical to ensure compliance with CGMP regulations and maintain the quality and safety of drug products. Thanks for reading! 🙌

👨💻Name & Position: Luke Fitzgerald - Compliance Specialist 🔎Background Info: With 4 years of experience with Pharmalliance and the Life Science compliance field, I have gained a tremendous amount of recent experience and knowledge. My background, with a BSc in Food Science and Health, is soon to be enhanced with an MSc in Quality Management and Validation, graduating this year! My focus has always been improving the quality systems and compliance of our clients. ✨My Passion: I am always excited by the prospect of working with new clients in a range of industry niches, and getting to come to grips with the specific challenges their operation faces. This involves building a lasting relationship with clients themselves, while delving into the particulars of their production process, quality system, and operating procedures. There’s no better feeling than finding the right solutions for a client after coming to learn and love their unique way of doing things! 🖐️Interesting Fact: I’m an avid traveller and always enjoy travelling to new places whenever the opportunity arises including, most recently, Vietnam! If you have any favourite destinations to recommend, please let me know! 👀Ambition for the Future: I’m enthusiastic about using my past experience and qualifications for the benefit of a wide range of industry partners. By driving success in this critical sector as part of Pharmalliance, I’m hoping to make a meaningful contribution to the life sciences landscape, while enhancing the company’s reputation, making our quality services available to more operations. The sky is the limit!

Contamination Control Tip No. 86 Transform your operation with our Contamination Control Strategy Services! 🌟 We offer: - CCS Audit - CCS Remediation - CCS Generation We have a suite of services to support you, no matter your phase of development. Our clients experience enhanced compliance with FDA, EU, and TGA standards, significant reductions in contamination risks, and improved product quality. Elevate your operation's standards and witness the difference in efficiency and safety. Find out more about our CCS services here: https://zurl.co/VuyO #fda, #contaminationcontrol, #ccs

🌟 Corrective Actions and Preventive Actions 🌟 CAPAs drives continuous improvement of your Contamination Control Strategy! 🛠️ Key benefits: 🔍 Informed by investigations and routine monitoring for informed decisions. 🔄 Evaluates all impacted elements to enhance CCS effectiveness. 🎯 Enhances multiple CCS controls for heightened quality assurance. 📝 Periodic lifecycle reviews incorporate new insights to refine practices. Let's empower excellence through proactive CAPA strategies! 💡 #CAPAs #QualityControl #ContinuousImprovement #ContaminationControl

🔍 Investigations in Quality Control 🔍 Investigations in quality control are essential! 🛠️ Key points: 📉 Arise from product complaints or testing, ensuring continuous improvement. 🔄 Conducted with an open mind, without predetermined outcomes. 📝 Standardized written plans streamline the investigation process. 🦠 Microbial risk assessments enhance process understanding. 🎯 Identify and strengthen weak points in the CCS for robust quality assurance. Let's enhance our processes and ensure top-tier quality every step of the way! 💪 #QualityControl #Investigations #ContinuousImprovement #MicrobialRiskAssessment

Contamination Control Tip No. 85 Transform your operation with our Contamination Control Strategy Services! 🌟 We offer: - CCS Audit - CCS Remediation - CCS Generation We have a suite of services to support you, no matter your phase of development. Our clients experience enhanced compliance with FDA, EU, and TGA standards, significant reductions in contamination risks, and improved product quality. Elevate your operation's standards and witness the difference in efficiency and safety. Find out more about our CCS services here: https://zurl.co/VuyO #fda, #contaminationcontrol, #ccs

🚨 It's Warning Letter Wednesday 🚨 This time we focus on a U.S. based manufacturer of biological products which received a Warning Letter on June 20th , 2024: Violations include: 1️⃣ Failure to Determine Donor Ineligibility The firm failed to determine as ineligible two donors of ocular Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) who had clinical evidence of sepsis, including two or more systemic responses to infection, documented during their hospital stays immediately preceding death. This failure violates 21 CFR 1271.75(a)(1). 💡Corrective Actions - Revise procedures to ensure all clinical evidence of sepsis and systemic responses to infection are considered during donor eligibility determinations. - Implement comprehensive training for personnel involved in donor screening and eligibility determination processes. 2️⃣ Non-Compliant Donor Eligibility Procedures Procedures used to evaluate donor eligibility did not adequately address clinical evidence and systemic responses to infection of sepsis during a hospital stay immediately preceding death, as required by 21 CFR 1271.47(a). 💡Corrective Actions - Update procedures (T-710 Donor Screening Criteria, TF-710-01 Donor Screening Criteria Guide, T-720 Donor Eligibility Determination, TF-710-02 Sepsis Algorithm) to include all relevant clinical evidence and systemic responses to infection for sepsis evaluation. - Conduct thorough review and approval of revised procedures by qualified personnel. 💡Immediate Steps to be Taken ✅ Engage an independent third-party consultant to assess donor eligibility procedures and provide recommendations for improvement. ✅ Develop and implement a corrective action plan with defined timelines for addressing each violation identified. These actions are crucial to ensure compliance with regulations governing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and to uphold the safety and quality of these products. Thanks for reading! 🙌

Contamination Control Tip No. 84 Transform your operation with our Contamination Control Strategy Services! 🌟 We offer: - CCS Audit - CCS Remediation - CCS Generation We have a suite of services to support you, no matter your phase of development. Our clients experience enhanced compliance with FDA, EU, and TGA standards, significant reductions in contamination risks, and improved product quality. Elevate your operation's standards and witness the difference in efficiency and safety. Find out more about our CCS services here: https://zurl.co/VuyO #fda, #contaminationcontrol, #ccs

Container closure (CC) systems play a pivotal role in pharmaceuticals! 🛡️ Key points to consider: 🔍 Must maintain drug properties and shield from external factors. 📦 Comprise primary and secondary closures for robust protection. 🚫 Critical in preventing product contamination. 📈 Ensures product integrity throughout its shelf life. Let's ensure our products reach their full potential with secure and reliable packaging solutions! 💼💊 #PharmaceuticalPackaging #ProductIntegrity #QualityControl #ContaminationPrevention