Compliance Trainings ’s Post

must follow the procedure

Standard Operating Procedure (SOP) on Procedures for Validating and Verifying the Performance of Established HPLC Methods - "Discover how to ensure accuracy and reliability in HPLC method performance with this detailed SOP. Learn the steps for validation, verification, and maintaining compliance in laboratory procedures. Tags: HPLC, SOP, Validation, Verification, Method Performance, Quality Control, Data Management." https://lnkd.in/efYegJ-p

User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) for Radiopharmaceutical With the plethora of new radiopharmaceuticals, manufacturing, dispensing and clinical applications, it is more important than ever to nail down User and Functional Requirement Specifications. There are so many questions to ask. What is the application? What is the general equipment you require? What is the surrounding infrastructure? What are the biological requirements for your product (viable/non-viable/sterility assurance level)? What are the expected dose rates from the isotopes (shielding requirements)? What is the industry best practices, standards and regulatory requirements (in your jurisdiction)? What Materials of Construction are suitable? Is a FAT, SAT, IQ, OQ, PQ required? With a well-established URS/FRS client will get what they need!

I learned basic concept of Pharmaceutical like GLP, GMP, GDP, cGMP, Validation, calibration, OOS/OOT, Deviation, Change control, CAPA, Qualification(IQ/OQ/PQ/DQ), Method validation & Parameter, Preparation & Conversion of Conc./ Calculation. Well known about Section of Quality Control Raw material, Finished product, Stability section, Method validation & Parameter, Lab support section.  Basic knowledge of Working & reference standard, Investigation procedure of Out of Specification / Out of Trend, Data Integrity & ALCOA +, ICH guideline, FDS Study etc.  Below instrument are handled personally during training, and performed calibration and used for assay test. Further I have theoretical knowledge of operation / Calibration Gas chromatography, Karl Fischer, FTIR instrument.

QuantCaps™ test kits are injectable-ready matrix matched reference materials used in drug analysis applications on Gas Chromatography (GC) and Liquid Chromatography (LC) platforms. These products allow laboratories to quickly standardize calibrations, validations, and method development for routine testing of drugs in complex matrices. Learn more here: https://hubs.ly/Q02vLNW_0 #laboratory #testing #workflow

which approach for signal to noise calculation in #pharmaceutical_industry has been accepted for #regulatories? is it acceptable to calibrate #HPLC instruments by #ASTM approach but do the #method_validation and release #analysis by #Peak_to_Peak approach? according to references like #Agilent_protocol, #European_Pharmacopoeia and #United_States_Pharmacopeia, suggested methods is collected in the following post. Are #Analytical_method_validation, #release_test and #calibration_method related in this way?

Understanding the Difference Between Calibration and Performance Verification in QC Labs In the Quality Control (QC) laboratory, ensuring accuracy and reliability of instruments is crucial for producing consistent and compliant results. Two key processes in this regard are calibration and performance verification. While they might seem similar, they serve distinct purposes. Let me explain with a simple example. Calibration involves adjusting an instrument to match a known standard. For instance, consider a pH meter used to measure the acidity or alkalinity of a solution. During calibration, you would use standard buffer solutions with known pH values, such as pH 4, pH 7, and pH 10. You adjust the pH meter to ensure it accurately reads these known values. This process ensures that the instrument provides precise pH readings. Performance Verification, on the other hand, is about ensuring that the instrument performs as expected within specified parameters, but without making any adjustments. Using the same pH meter example, performance verification would involve measuring the pH of a standard buffer solution (e.g., pH 7) to check if the meter still reads 7.0, confirming that it remains accurate over time. If it doesn’t, it may indicate the need for recalibration or maintenance. In summary Calibration = Adjusting the instrument to a known standard. Performance Verification = Checking if the instrument maintains accuracy over time. Both processes are vital for maintaining the integrity of our QC lab results and ensuring compliance with regulatory standards. #QualityControl #Calibration #PerformanceVerification #Pharmaceuticals #LabExcellence #RegulatoryCompliance

🔍 Dive into the world of pharma manufacturing with Principal and Mechanical Engineer Erik Eaves, P.E. in his article “Key Considerations for Designing an Efficient Material Transfer Station Suite” for Pharma Manufacturing’s July issue. 🏭💡 Discover the essential elements for designing top-tier Material Transfer Stations. Learn how containment, HVAC, controls, and electrical needs play a pivotal role in CGMP compliance! 🌟 #drugmanufacturing, #HVAC, #mcclureengineeringpublished, #pharmaceuticalmanufacturing, #mechanicalengineering #mcclureengineeringstl https://bit.ly/4d8Fvui

𝗡𝗲𝘄! 𝗣𝗿𝗼𝗷𝗲𝗰𝘁𝗫: 𝗖𝘂𝘁𝘁𝗶𝗻𝗴-𝗘𝗱𝗴𝗲 𝗦𝗲𝗿𝗶𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝘀 𝗣𝗮𝗰𝗸𝗮𝗴𝗶𝗻𝗴 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗳𝗼𝗿 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 Serialization presents unique challenges because of the regulatory requirements for product traceability and anti-counterfeiting measures in the pharmaceutical industry. Our team’s work falls under GrayMatter’s Automation & Controls Offering, which includes PLC programming, SCADA/HMI design, machine control, control logic testing, and many other services. Full ProjectX Case Study: https://lnkd.in/g65Ch3N3 #serialization #pharmaceuticals #industrialcontrols