Howard Systems International’s Post

General process flow of activities typically performed in a raw material quality control lab in a pharmaceutical industry: 1. **Sampling:** - Collecting representative samples of raw materials. 2. **Identification and Verification:** - Verifying the identity of received raw materials. - Performing visual inspections and comparing against specifications. 3. **Physical Testing:** - Determining physical characteristics like particle size, density, and moisture content. 4. **Chemical Testing:** - Analyzing chemical composition through methods like titration, chromatography, and spectroscopy. 5. **Microbiological Testing:** - Conducting tests to ensure raw materials are free from microbial contamination. 6. **Purity Testing:** - Assessing the purity of raw materials, checking for impurities and unwanted substances. 7. **Quantitative Analysis:** - Determining the quantity of active ingredients in the raw materials. 8. **pH Testing:** - Measuring the acidity or alkalinity of materials. 9. **Dissolution Testing:** - Evaluating how well the raw material dissolves in a specific solvent. 10. **Stability Testing:** - Assessing the stability of raw materials under different conditions. 11. **Documentation:** - Maintaining accurate and detailed records of all tests performed. 12. **Calibration of Equipment:** - Regular calibration of lab equipment to ensure accurate results. 13. **Method Validation:** - Validating the testing methods used in the lab to ensure reliability. 14. **Quality Assurance:** - Implementing quality control processes to meet regulatory standards. 15. **Data Analysis and Reporting:** - Analyzing test results and preparing reports for further action or documentation. 16. **Storage and Handling:** - Ensuring proper storage conditions for raw materials to maintain their quality. 17. **Training and Development:** - Continuous training of lab personnel on new methods and technologies. 18. **Compliance with Regulations:** - Ensuring that all activities comply with relevant pharmaceutical regulations. 19. **Out-of-Specification Investigations:** - Investigating and documenting any deviations from established specifications. 20. **Communication:** - Communicating results and findings to relevant departments or stakeholders.

CSV and PLC validation is the process of ensuring that your systems meet the requirements of your business and regulatory standards. It is a critical step in ensuring the safety, reliability, and quality of your products . . . #csvvalidation #plcvalidation #industrialautomation #quality #laboratory #pharmacy #nabl #calibration #validation #analysis #qualitycontrol #engineering #manufacturing #industrial #iso #hvac #thermal #technicalanalysis #plcvalidation #instrumentation #research #water #medical #medicine #fda #laboratory #microbiology #chemical #technical #chemical #industrial

CSV and PLC validation Process Framework as per GAMP 5 . . . #csvvalidation #plcvalidation #industrialautomation #quality #laboratory #pharmacy #nabl #calibration #validation #analysis #qualitycontrol #engineering #manufacturing #industrial #iso #hvac #thermal #technicalanalysis #plcvalidation #instrumentation #research #water #medical #medicine #fda #laboratory #microbiology #chemical #technical #chemical #industrial

Here are some key qualities and skills that are important for an Analyst in Quality Control: Attention to Detail: Meticulously observing, recording, and analysing data is essential for ensuring accurate and reliable test results. Technical Proficiency: Expertise in analytical techniques and instruments specific to pharmaceutical quality control, such as HPLC, GC, spectroscopy, and dissolution testing, is crucial. Compliance and Regulations: A deep understanding of regulatory requirements (e.g., FDA, EMA) and strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) are necessary to ensure that all testing procedures and documentation comply with regulatory standards. Problem-Solving Skills: The ability to detect deviations or discrepancies in test results, investigate the underlying causes, and implement corrective actions is key to maintaining product quality and compliance. Teamwork and Collaboration: Effective collaboration in cross-functional teams with chemists, microbiologists, engineers, and regulatory affairs personnel is vital for coordinated quality control efforts. Organizational Skills: The ability to manage multiple tasks, prioritize workloads, and adhere to deadlines while ensuring accuracy and precision in testing and documentation is important. Communication Skills: The ability to communicate testing procedures, results, and any issues or deviations to stakeholders clearly and effectively, both verbally and in written reports, is essential. Critical Thinking: Evaluating data critically, interpreting trends, and making informed decisions about the quality and release of pharmaceutical products are imperative. Adaptability: Being flexible enough to work in a dynamic environment with changing priorities and regulatory requirements while upholding high standards of quality and compliance is necessary. Ethical Standards: A commitment to integrity and ethical behavior in all aspects of pharmaceutical quality control is fundamental, ensuring the safety and efficacy of products for patients. These qualities are not only pivotal to the success of an Analyst in Pharmaceutical Quality Control but also to the integrity of the pharmaceutical industry as a whole. ✍ 📒

Waters Computerized Systems Validation Project The pharmaceutical industry is heavily regulated, and data integrity is essential. That's why Waters offers a comprehensive Computerized Systems Validation (CSV) project to help you meet all current requirements and expectations. Our experienced consultants will work with you to complete a risk assessment, develop a validation plan, and execute all necessary testing. We'll also help you create and implement a configuration specification to ensure that your system is always in compliance. By engaging Waters in your CSV project, you can save up to 50% of the time it would take to do it yourself. And with our expertise on our side, you can be confident that your system will be validated to the highest standards. Benefits of working with Waters for CSV: • Time-saving and increased productivity • Standardized CSV framework per GAMP 5 approach • Customizable validation services according to your needs and budget • Increased confidence in managing user management within Empower Contact us today to learn more about our CSV project and how we can help you achieve data integrity compliance. . . . #kromtekindo #kromtekindoutama #waterscorporation #hplc #uhplc #uplc #chromatography #laboratory #chemical #indonesia #fyp #technology #Networking #Business #community #seminar #workshop #training #educational #education #Event #Follow #Like #Innovation #reels #Markets #SocialMedia #marketing #digitalmarketing #Pharma #Promo

good opportunity

Open to work! Hello Connections! I am looking for a job change as a QC Officer, Experience: 11 Months Job role: Raw material analysis, Packing material analysis, Prepared - COA, SOP, RDS Industry: Pharmaceutical Industry Here are some skills highlights Analytical Chemistry: Proficiency in HPLC, GC, FTIR, and UV-Vis spectroscopy. Pharmacopeial Standards: Knowledge of USP, EP, and BP standards. QC: Understanding of GMP and GLP guidelines. Documentation: Ability to prepare COAs, SOPs, and RDS accurately. Data Analysis: Proficiency in analyzing and interpreting analytical data. Problem-Solving: Ability to troubleshoot issues and propose solutions. Communication: Effective communication skills for collaboration and reporting. Attention to Detail: Ensuring accuracy in testing and documentation. Regulatory Knowledge: Understanding of relevant regulations. Teamwork: Collaboration in cross-functional teams to achieve objectives. Kindly connect and provide references. #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #analyticalchemistry #qc #gmp #dataanalysis #documentation #teamwork #careerempowerment #professionalgrowth #careergrowth #openforwork #lookingforjobchange #connect #share

🔍 Analyzing Steam-In-Place (SIP) Process Data for Biotech/Pharmaceutical Manufacturing Process Compliance 🦠🌡️💊 Ensuring the integrity and compliance of biotech and pharmaceutical manufacturing processes is paramount. An in-depth Steam-In-Place (SIP) process analysis should leverage advanced statistical techniques and visualization tools. 📊 Visualizing Variation: Intuitive visualizations can track variation over time for different process cycles using temperature and pressure data collected during the SIP process. These insights are crucial for identifying trends and anomalies. 🔍 Statistical Insights: Calculating measures such as mean, standard deviation, and CPk (Process Capability Index) for temperature and pressure can yield deeper insights into process stability and performance. This quantitative analysis forms the foundation of quality assurance efforts for SIP processes. 🔄 Understanding Relationships: Exploring the correlation between temperature and pressure allows for uncovering any dependencies and a better understanding of their impact on the SIP process. This knowledge is instrumental in optimizing process parameters for maximum efficiency. 📈 Validation and Recommendations: Based on the analysis, a comprehensive report assessing the validation status of the SIP process should be completed. In instances where temperature and/or pressure exceeded acceptable ranges, actionable recommendations should be implemented to ensure compliance and product quality. 🎯Targeted Recommendations: Based on the findings, the following targeted actions for enhanced process consistency were proposed: + Temperature Control: - Implement tighter control limits around the mean temperature to reduce fluctuations. - Introduce automated monitoring systems to detect and correct deviations promptly. - Adjust heating or cooling rates to achieve more uniform temperatures throughout the process. + Pressure Regulation: - Optimize pressure regulation mechanisms to minimize variations during the SIP cycle. - Conduct a thorough review of equipment and piping systems for potential leaks or inefficiencies. - Explore using advanced pressure control technologies for finer adjustments and stability. + Continuous Improvement: - Foster a culture of continuous improvement, encouraging cross-functional collaboration to identify and address process inefficiencies. - Regularly review and update standard operating procedures (SOPs) based on data-driven insights and best practices. - Invest in training programs to empower staff with the skills and knowledge required for optimal SIP process management. 👉 In the biotech and pharmaceutical settings, strengthening commitment to quality and regulatory compliance underscores companies' dedication to continuous improvement while performing manufacturing processes. #QualityAssurance #Biotech #Pharmaceuticals #SIP #DataAnalysis #ProcessOptimization #ProcessImprovement #ProcessEngineering #OpsEngineering #Python #Visualizations

Dear Laboratory Professionals, We are pleased to announce our forthcoming 2-day virtual workshop on Analytical Instrument Qualification scheduled for the 4 -5 June 2024. Objective Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance’s. Recent EU and FDA regulatory enforcement actions demonstrate that qualification, validation and electronic records are priority areas for inspection. Recently there have been many FDA warning letters and the frequency of EU enforcement action in these areas. This training course guides you through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidances from national and international regulatory sources. Once completed you will have the confidence to conduct analytical instrument qualification and computer system validation, ensuring you are compliant with global regulations. Learning Outcomes · Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5 · Be able to allocate equipment and systems to USP <1058> and GAMP 5 categories and to design and execute suitable qualification/validation protocols · Understand the logic and principles of instrument qualification and system validation from planning to reporting · Be able to develop a qualification and validation strategy · Understand how to archive raw data from hybrid systems: electronic vs. paper · Be able to define and demonstrate regulatory compliance to auditors and inspectors · Learn how to ensure, document and audit the integrity of GMP records Target Audience This course is aimed at professionals involved in qualifying and validating analytical equipment and computer systems. These includes IT/IS managers and system administrators | Quality Assurance Personnel | Quality Control Professionals | Laboratory Personnel | Analytical Scientists | Validation Scientists | Regulatory Affairs |Training Departments | Documentation Departments. Booking Should you require booking prior to our sales staff contacting you, kindly complete the registration form (last page of the brochure). Limited seats available. For more information and to get the registration form.kindly send an email at info@cstvalconsulting.co.za