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🔍 Quality assurance and quality control are essential pillars in ensuring superior product and service delivery. Quality assurance sets the stage by proactively preventing defects through robust processes and standards. On the other hand, quality control steps in to detect and correct any issues that slip through the cracks. 🚀 QA focuses on prevention, setting stringent guidelines to ensure products meet quality standards upfront, saving time and resources. QC, on the flip side, is all about correction, pinpointing and rectifying defects in the final product or service through inspections and tests. 🎯 Balancing prevention and correction is key for businesses striving for excellence in their quality management. By melding the strengths of both QA and QC, organisations can elevate their quality control processes and surpass customer expectations. 🌟 How do you harmonise prevention and correction in your quality management strategy? Share your insights below or personal message me, happy to deep dive! #QualityAssurance #QualityControl #QualityManagement #BizzMine #pharmaceuticals

𝘿𝙤𝙘𝙪𝙢𝙚𝙣𝙩𝙖𝙩𝙞𝙤𝙣 𝙄𝙨 𝘾𝙤𝙢𝙥𝙡𝙚𝙩𝙞𝙤𝙣: 𝘼 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝘾𝙤𝙣𝙩𝙧𝙤𝙡 𝙀𝙨𝙨𝙚𝙣𝙩𝙞𝙖𝙡. In the realm of quality control and assurance, the adage "𝐈𝐟 𝐢𝐭'𝐬 𝐧𝐨𝐭 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐞𝐝, 𝐢𝐭'𝐬 𝐧𝐨𝐭 𝐝𝐨𝐧𝐞" underscores a fundamental truth: effective documentation is the backbone of any successful quality management system. Whether in pharmaceuticals, manufacturing, or any other industry, meticulous documentation practices are essential for ensuring accuracy, traceability and accountability of our processes. Recently, I encountered a challenging situation where I couldn't prove to my technical director that I had performed a critical task for a particular analysis. Despite completing the task, I had not documented it in the equipment usage logbook. This experience taught me the importance of thorough and immediate recording or documentation of our work in ensuring accountability and traceability. I've since implemented a more rigorous documentation process to avoid similar issues in the future. Learn from my mistake and always document your work diligently. How has the lack of proper documentation impacted your work or organization? Share your experiences and let's discuss the importance of documentation in ensuring quality and compliance. Have a wonderful week ahead. Still your girl, Jennifer Quality Control Expert ................................................. If you're just seeing my post for the first time, I'm Jennifer Assayomo, a Quality Control Expert in the pharmaceutical industry. I ensure pharmaceutical products meet the highest standards of quality and safety. With a background in Biochemistry and years of experience, I'm dedicated to upholding excellence in every aspect of my work. #Documentation #QualityControl #Compliance #20daylinkedinchallengewithhaoma

It is used in the everyday life, e.g. commodities of (good) quality • Whatever the quality means: we feel that it is a positive value • (It costs money!) • If it is value then it is valued • If it is valued: this depends on the concrete society. Decision on the value – it means we should measure the quality! •„Measure everything what is measurable and make measurable what is not!” Quality from the point of view of the producer Quality defined through conformity • Ability of the technology to assure that the product will conform to the requirements specified during planning • It depends on several factors, such as • planning and organisation of the production technology • performance of the equipments and of the technology • the starting materials • training of workers and management’s control • level of final quality control based on statistical considerations. #qa #qms #quality #assurance #pharmaceuticals #pharmaceuticalindustry #managementsystems #regulatoryaffairs #hireme #hire #hiretalent #jobfinder #training #qmstraining #qmsjobs

"Cultivating Quality Excellence: The Role of #IPQC and #QCSampling in Manufacturing" In-Process Quality Control (IPQC) and QC Sampling: The Pillars of Product Excellence: In the world of manufacturing, quality control is paramount. That's where In-Process Quality Control (IPQC) and QC Sampling step in as the guardians of consistent product quality. 🛠️ IPQC Essentials: IPQC ensures that every step in the production process is a well-oiled machine. It's all about: 1.Monitoring Process Parameters: Keeping a close eye on critical factors that influence the final product's quality. 2.Real-time Inspection: Vigilant operators spot abnormalities and deviations in real time. 3.Testing and Analysis: Sampling and testing to ensure product properties are A-OK. 4.Documentation: Keeping meticulous records to track changes and maintain product quality. 5.Process Optimization: Identifying opportunities for efficiency and excellence. 🔍 The Art of QC Sampling: QC Sampling is like quality control's Sherlock Holmes. It works its magic through: 1.Sample Selection: Carefully chosen samples to represent the entire batch. 2.Inspection and Testing: Rigorous examination of the samples to meet established standards. 3.Evaluation: Decisions made based on test results. 4.Decision Making: To accept, reject, or further investigate the batch. 5.Statistical Techniques: Using data to make informed decisions. 6.Documentation: Keeping the story of quality control. 💡 Both IPQC and QC Sampling are your allies in the quest for unmatched product quality. They keep defects at bay, maintain customer satisfaction, and ensure manufacturing efficiency. 👏 #QualityControl #ManufacturingExcellence #ProductQuality #PHARMA #pharmaceutical #Foodsafety

Navigating the complexities of Quality Control (QC) in the pharmaceutical industry requires not just a keen eye for detail, but also a partner who truly understands the intricacies of the field. As a Technical Resourcer at LSC, my focus is on connecting QC professionals with opportunities that not only match their skill set but also propel their careers forward. For QC professionals looking to advance their careers, consider these five must-haves: 1. Regulatory Knowledge: Stay updated with FDA, EMA, and other regulatory bodies' guidelines. This knowledge is crucial for ensuring compliance and maintaining the highest quality standards. 2. Analytical Skills: A robust understanding of analytical techniques and the ability to interpret data accurately are essential for making informed decisions that impact product quality. 3. Attention to Detail: Precision is key in QC. A meticulous approach to your work can prevent costly errors and ensure product integrity. 4. Communication Skills: Clear and effective communication is vital when collaborating with cross-functional teams and when documenting processes and outcomes. 5. Continuous Improvement Mindset: The pharmaceutical industry is ever-evolving. Embrace ongoing learning and adaptability to stay ahead in your field. If you are a QC professional, looking for a new opportunity, connect with me to discover what opportunities await you!

Aastrid Lifesciences Pvt. Ltd. – Quality Management Quality Management at Aastrid Lifesciences is multifaceted and involves a holistic approach encompassing compliance, control, improvement, and a commitment to delivering safe and effective products to consumers. We at Aastrid believe that Quality Management should drive innovation, operational excellence and customer satisfaction in our company. Stability and sustainability are biproducts of Quality Management. Brief overview of our Quality Management philosophy: Regulatory Compliance: 1.      Adherence to stringent regulations and standards set by health authorities and other regulatory bodies. 2.      Compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) is fundamental to quality management. Quality Control (QC): 1.      Monitoring and testing products during various stages of manufacturing to ensure they meet predetermined quality standards. 2.      Testing of raw materials, intermediate products, and final products for safety, purity, potency, and other specifications. Quality Assurance (QA): 1.      Establishing processes and procedures to ensure that products are developed and manufactured in a consistent and controlled manner. 2.      Compliance, auditing, documentation, and validation of processes. Quality Improvement: 1.      Continuous improvement for enhancing processes and achieving better quality outcomes. 2.      Use methodologies of Lean and Total Quality Management (TQM) to identify areas for improvement and implement changes for increased efficiency and quality. Risk Management: 1.      Identifying and managing risks related to product quality is crucial. 2.      Proactive assessment of potential risks throughout the product lifecycle and implementing strategies to mitigate these risks effectively. Training and Education: 1.      Employees to be informed about quality standards, procedures, and regulations. 2.      Enhancing awareness and fostering a culture of quality within the organization. Miscellaneous Aspects: 1.      Documentation and Record Keeping. 2.      Supplier and Vendor Management. 3.      Customer Feedback and Monitoring. #aastridlifesciences              #pharmaintermediates        #specialitychemicals #apiintermediates  #researchanddevelopment             #innovation               #CDMO  #CRO #qualitymanagement

GMP COMPLIANCE: SUPPLIERS QUALIFICATION - Part I #Supplierqualification is a critical process for #pharmaceuticalcompanies to ensure the #quality and #reliability of the #materials, #components, and #services provided by their #suppliers. Here are some key steps and considerations for approaching supplier qualification: 1. Define #SupplierRequirements: Start by clearly defining the specific requirements for suppliers based on the type of product or service they provide. Consider aspects such as quality standards, regulatory compliance, GMP/GDP requirements, certifications, track record, technical capabilities, and capacity to meet your company’s needs. 2. #SupplierSelection: Identify potential suppliers through market research, recommendations, industry networks, and trade shows. 3. Create a list of potential candidates based on their alignment with your defined requirements. Conduct a #preliminaryassessment of their capabilities, reputation, and suitability. 4. #PreQualificationAssessment: Before engaging in a full qualification process, conduct a pre-qualification assessment to evaluate suppliers’ basic credentials and capabilities. This may involve reviewing their documentation, certifications, quality systems, and past performance. Eliminate suppliers who do not meet the basic criteria. 5. #OnSiteAudit: For suppliers who pass the pre-qualification assessment, conduct an on-site audit of their facilities. This audit should evaluate their manufacturing processes, quality control systems, personnel qualifications, infrastructure, storage conditions, and adherence to GMP/GDP guidelines. Verify their compliance with relevant regulations and standards. 6. #QualityAgreement: Establish a quality agreement with the selected suppliers. This agreement should outline the responsibilities, expectations, and quality standards that both parties need to meet. 7. #OngoingMonitoring: Implement a robust system for ongoing monitoring and assessment of suppliers. This can include regular audits, periodic performance reviews, and monitoring of quality metrics and compliance records. 8. #RiskManagement: Assess the risks associated with each supplier and their impact on your product quality and supply chain. Identify critical suppliers and develop contingency plans to mitigate risks. 9. #ContinuousImprovement: Foster a culture of continuous improvement with your suppliers. Encourage feedback, collaborate on process optimization, and share best practices. 10. #Documentation and #RecordKeeping: Maintain comprehensive documentation and records throughout the supplier qualification process. Supplier qualification is an ongoing process, and it is crucial to periodically reassess and requalify suppliers to ensure their continued suitability and compliance. #qualitycompliance #vendormanagement If you like this post follow me on LinkedIn

GMP COMPLIANCE: SUPPLIERS QUALIFICATION - Part 1 #Supplierqualification is a critical process for #pharmaceuticalcompanies to ensure the #quality and #reliability of the #materials, #components, and #services provided by their #suppliers. Here are some key steps and considerations for approaching supplier qualification: 1. Define #SupplierRequirements: Start by clearly defining the specific requirements for suppliers based on the type of product or service they provide. Consider aspects such as quality standards, regulatory compliance, GMP/GDP requirements, certifications, track record, technical capabilities, and capacity to meet your company's needs. 2. #SupplierSelection: Identify potential suppliers through market research, recommendations, industry networks, and trade shows. 3. Create a list of potential candidates based on their alignment with your defined requirements. Conduct a #preliminaryassessment of their capabilities, reputation, and suitability. 4. #PreQualificationAssessment: Before engaging in a full qualification process, conduct a pre-qualification assessment to evaluate suppliers' basic credentials and capabilities. This may involve reviewing their documentation, certifications, quality systems, and past performance. Eliminate suppliers who do not meet the basic criteria. 5. #OnSiteAudit: For suppliers who pass the pre-qualification assessment, conduct an on-site audit of their facilities. This audit should evaluate their manufacturing processes, quality control systems, personnel qualifications, infrastructure, storage conditions, and adherence to GMP/GDP guidelines. Verify their compliance with relevant regulations and standards. 6. #QualityAgreement: Establish a quality agreement with the selected suppliers. This agreement should outline the responsibilities, expectations, and quality standards that both parties need to meet. 7. #OngoingMonitoring: Implement a robust system for ongoing monitoring and assessment of suppliers. This can include regular audits, periodic performance reviews, and monitoring of quality metrics and compliance records. 8. #RiskManagement: Assess the risks associated with each supplier and their impact on your product quality and supply chain. Identify critical suppliers and develop contingency plans to mitigate risks. 9. #ContinuousImprovement: Foster a culture of continuous improvement with your suppliers. Encourage feedback, collaborate on process optimization, and share best practices. 10. # Documentation and #Recordkeeping: Maintain comprehensive documentation and records throughout the supplier qualification process. Supplier qualification is an ongoing process, and it is crucial to periodically reassess and requalify suppliers to ensure their continued suitability and compliance. #qualitycompliance #vendormanagement If you like this post follow me on LinkedIn

AUDITING AND SUPPLIER QUALITY INSPECTIONS: A CANDID DISCUSSION In our latest unscripted "real talk" conversation, Vanessa Figueroa and Brian Scot Patterson delve into the critical world of Auditing and Supplier Quality Inspections. From the importance of #auditing to the challenges of remote #inspections, they share insights gained from years of experience. They emphasize the need for thorough understanding, good communication, and the significance of in-person audits, especially in industries where transparency and product quality are paramount. Join this insightful conversation to gain valuable perspectives on optimizing supplier relationships and ensuring the highest quality standards. #pharma #biotech #qualityassurance #microbiology