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I think , the distribution of time during laboratory activities can be diffrent based analyst experience and preferences, also with factors like the complexity of test, number of steps , extent of manipulation . For example some tests can have an long test duration not due to manipulation but more due to numerous steps, such as drying time , injection time, shaking time, .. From my experience in the pharmaceutical industry, with GDP and GLP requirements, approximately 40 to 50% of the total time for documentation , data transcription and calculations needed to ensures clarity, reproducibility, transparency, and traceability of the analysis process and results. For regular analysis I would say: 1- 15% 2-40% 3-20%, 4-10%, 5-15 %

Attention laboratory chemists! We need your feedback for a case study aimed at enhancing the efficiency of laboratory analysis process. We want to identify the activities that consume the most time during the process. As a laboratory chemist, your input is invaluable to us. Please take a moment to estimate the percentage of time spent on each of the following activities during the analysis process: 1- Reflection on the Analytical Method 2- Method Execution 3- Documentation 4- Data Transcription 5- Calculation We would appreciate it if you could rate each option in the comment section. Unfortunately, LinkedIn does not provide poll options with rating functionality, but we hope to have this feature soon. Copy this in to the comment and change the percentages to reflect your experience 1- 20% ,2-20%, 3-20%, 4-20%, 5-20% Thank you for your cooperation. #laboratory #laboratorytechnician #laboratoryprofessionals #qc #pharma #continuousimprovement #lims #eln #quality

good opportunity

Differences between #Chemical and #Biological #CleaningValidation:Similarities between Chemical and Biological Cleaning Validation: 1. Validation Purpose: Both chemical and biological cleaning validation aim to ensure that cleaning processes effectively remove contaminants and maintain cleanliness in a #laboratory or manufacturing #facility. 2. Validation Documentation: Both types of cleaning validation require thorough documentation of the validation process, including cleaning procedures, sampling plans, test results, and any corrective actions taken. 3. Risk Assessment: Both chemical and biological cleaning validation involve assessing potential risks associated with inadequate cleaning, such as cross-contamination, product quality issues, or compromised safety. 4. Validation Team: Both types of cleaning validation typically involve a multidisciplinary team comprising microbiologists, chemists, engineers, quality assurance personnel, and facility staff to ensure comprehensive validation. 5. Validation Strategy: Both chemical and biological cleaning validation require the development of a validation strategy that outlines the scope, objectives, methods, acceptance criteria, and validation frequency. 6. Equipment Monitoring: Both types of cleaning validation may involve monitoring equipment performance and cleanliness to ensure effective cleaning and prevent contamination. 7. Training Requirements: Both chemical and biological cleaning validation necessitate training programs for personnel involved in the cleaning process to ensure proper implementation of cleaning procedures. 8. Validation Reports: Both types of cleaning validation require the preparation of validation reports summarizing the validation activities, results, conclusions, and any recommendations for improvement. 9. Validation Review: Both chemical and biological cleaning validation should undergo periodic review to assess the effectiveness of the cleaning process and identify opportunities for optimization. 10. Compliance with Standards: Both types of cleaning validation should comply with applicable regulatory standards, guidelines, or industry best practices to ensure the validity and reliability of the validation process. #Similarities in first Comments

Dear Laboratory Professionals, We are pleased to announce our forthcoming 2-day virtual workshop on Analytical Instrument Qualification scheduled for the 27-28 May 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. Kind Regards, Bridget Sithole Email:info@cstvalconsulting.co.za Mobile:0606837455

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

Differences between #Chemical and #Biological #CleaningValidation:Similarities between Chemical and Biological Cleaning Validation: 1. Validation Purpose: Both chemical and biological cleaning validation aim to ensure that cleaning processes effectively remove contaminants and maintain cleanliness in a #laboratory or manufacturing #facility. 2. Validation Documentation: Both types of cleaning validation require thorough documentation of the validation process, including cleaning procedures, sampling plans, test results, and any corrective actions taken. 3. Risk Assessment: Both chemical and biological cleaning validation involve assessing potential risks associated with inadequate cleaning, such as cross-contamination, product quality issues, or compromised safety. 4. Validation Team: Both types of cleaning validation typically involve a multidisciplinary team comprising microbiologists, chemists, engineers, quality assurance personnel, and facility staff to ensure comprehensive validation. 5. Validation Strategy: Both chemical and biological cleaning validation require the development of a validation strategy that outlines the scope, objectives, methods, acceptance criteria, and validation frequency. 6. Equipment Monitoring: Both types of cleaning validation may involve monitoring equipment performance and cleanliness to ensure effective cleaning and prevent contamination. 7. Training Requirements: Both chemical and biological cleaning validation necessitate training programs for personnel involved in the cleaning process to ensure proper implementation of cleaning procedures. 8. Validation Reports: Both types of cleaning validation require the preparation of validation reports summarizing the validation activities, results, conclusions, and any recommendations for improvement. 9. Validation Review: Both chemical and biological cleaning validation should undergo periodic review to assess the effectiveness of the cleaning process and identify opportunities for optimization. 10. Compliance with Standards: Both types of cleaning validation should comply with applicable regulatory standards, guidelines, or industry best practices to ensure the validity and reliability of the validation process.

𝗚𝗢𝗢𝗗 𝗟𝗔𝗕𝗢𝗥𝗔𝗧𝗢𝗥𝗬 𝗣𝗥𝗔𝗖𝗧𝗜𝗖𝗘-𝗚𝗟𝗣 Ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. 𝙀𝙨𝙨𝙚𝙣𝙩𝙞𝙖𝙡 𝙀𝙡𝙚𝙢𝙚𝙣𝙩𝙨 𝙤𝙛 𝙂𝙤𝙤𝙙 𝙇𝙖𝙗𝙤𝙧𝙖𝙩𝙤𝙧𝙮 𝙋𝙧𝙖𝙘𝙩𝙞𝙘𝙚 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝙈𝙖𝙣𝙖𝙜𝙚𝙢𝙚𝙣𝙩 It's the importance of a robust quality management system to ensure that all aspects of a study are conducted in accordance with predefined protocols and procedures. This includes documentation of all study procedures, data collection, analysis, and reporting. 𝙁𝙖𝙘𝙞𝙡𝙞𝙩𝙞𝙚𝙨 𝙖𝙣𝙙 𝙀𝙦𝙪𝙞𝙥𝙢𝙚𝙣𝙩 The must maintain appropriate facilities and equipment to ensure the accuracy and reliability of data. This includes calibration and maintenance of instruments, proper storage of chemicals and samples, and appropriate laboratory conditions 𝙚𝙭𝙖𝙢𝙥𝙡𝙚-𝙩𝙚𝙢𝙥𝙚𝙧𝙖𝙩𝙪𝙧𝙚, 𝙝𝙪𝙢𝙞𝙙𝙞𝙩𝙮 as required by the study protocol. 𝙋𝙚𝙧𝙨𝙤𝙣𝙣𝙚𝙡 It's appropriately trained and qualified to perform their assigned tasks. Standard operating procedures, safety practices, and data recording requirements. Clear lines of responsibility should be established to ensure accountability for each aspect of the study. 𝙎𝙩𝙖𝙣𝙙𝙖𝙧𝙙 𝙊𝙥𝙚𝙧𝙖𝙩𝙞𝙣𝙜 𝙋𝙧𝙤𝙘𝙚𝙙𝙪𝙧𝙚𝙨-𝙎𝙊𝙋𝙨 GLP requires the development and implementation of SOPs for all critical laboratory procedures. SOPs help to standardize processes, minimize variability, and ensure consistency in data collection and reporting. 𝘿𝙤𝙘𝙪𝙢𝙚𝙣𝙩𝙖𝙩𝙞𝙤𝙣 𝙖𝙣𝙙 𝙍𝙚𝙘𝙤𝙧𝙙-𝙠𝙚𝙚𝙥𝙞𝙣𝙜 All data, observations, calculations, and interpretations must be recorded in a timely manner and maintained in an organized and secure manner to facilitate review and audit. 𝙎𝙩𝙪𝙙𝙮 𝙋𝙧𝙤𝙩𝙤𝙘𝙤𝙡 The study protocol that outlines the objectives, design, methodology, and data analysis procedures. Any changes to the protocol must be documented, justified, and approved by the study director before implementation. 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝘼𝙨𝙨𝙪𝙧𝙖𝙣𝙘𝙚 Quality assurance activities, including internal and external audits, are essential to verify compliance with GLP standards and identify any deficiencies or opportunities for improvement. 𝗖𝗔𝗣𝘼 - 𝗖𝗼𝗿𝗿𝗲𝗰𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗽𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝘃𝗲 𝗮𝗰𝘁𝗶𝗼𝗻𝘀 should be implemented in response to audit findings to ensure ongoing compliance. 𝙍𝙚𝙥𝙤𝙧𝙩𝙞𝙣𝙜 The accurate and transparent reporting of results, including any uncertainties or limitations in the data. The final report should include a detailed description of the study design, methods, results, and conclusions, presented in a format that is clear and understandable to regulatory authorities. #GLP #pharmaceutical #diagnostic #Foodindustry #laboratory #AnithaGnanasekaran

QC LAB REFRESH: Recommendations on setting the expiry period for commercial and in-house-prepared reagents used in the laboratories _ Part II- EDQM #Reagents are an integral part of any #laboratory and as such play a vital role in ensuring the validity of #analyticalresults. Reagents must be suitable for the intended use. ‼️👀 Consideration should be given to the #accompanyingdocumentation and appropriate physico-chemical or biological #criticalqualityattributes for the intended purpose/s. In the laboratory, two major types of reagents are generally distinguished: 1️⃣commercial (off-the-shelf, #readytouse) 2️⃣ prepared in the laboratory (#inhousereagents) using the former. These two types of reagents are mainly dealt with separately throughout this document. ‼️👀 It should be noted that the principles of #FIFO (First In-First Out) or #FEFO (First Expired-First Out) should be applied when using reagents. The #shelflife for an unopened product or expiry period after first opening is usually set taking into account its #stability. This can be a challenging task because most manufacturers give the shelf life of the unopened product and do not provide information on how long the reagent is stable once the container has been opened. The recommendations for the shelf life of reagent solutions prepared and used in laboratories and presented in this document were established based on #scientificdata (including validation data obtained from quality control charts, guidelines, standards, pharmacopoeias, publications, etc.) and on the analytical experience and knowledge of OMCLs. ✅ Preparation times, costs, sustainable waste management policies and environmental protection concerns were also considered during the preparation of these recommendations. ✅ This document is based on the laboratory experience of the #OMCL Network. Its purpose is to help maintain the quality of the work carried out in the laboratory on a daily basis and ensure that the results obtained are valid. ✅ The recommendations on the shelf life of reagent solutions provided herein should allow laboratories to assess whether a given solution can be used safely and reliably as they take into account various factors that contribute to the degradation of some reagents (temperature, air exposure, moisture, ...). ‼️ For the purpose of this document, the #expiryperiod of a #reagentsolution should be understood as the period of time during which the reagent is stable and can be used for a given type of analysis. ‼️It should be noted that the same reagent may be unfit for use for some purposes because it has expired, but still suitable for other purposes. ‼️Purchase or preparation of reagents and reagent solutions in quantities (volumes) not adapted to current needs should be avoided, as unnecessary disposal that does not take into account the possibility of prolonged use potentially constitutes a direct threat to the environment. If you like this post follow me on LinkedIn