Luigi Roggia’s Post

WHY ARE THERE THREE BATCHES USED FOR EXHIBIT/VALIDATION? is there any regulatory requirements for 3 batches? Why just three batches, not one, two, or four? The FDA / ISO have not specified the three batches concept, so the answer to your questions is that there are no criteria for it. The concept of three batches is not discussed in the "FDA guidelines for industry on process validation general principles and practices," nor is the number of batches specified. Actually, the amount of risk involved determines how many batches are needed for validation. It is up to the pharmaceutical company to figure out how many batches are needed for manufacturing. To support the statistical data, the number of batches is chosen primarily for that reason. For the product, we will need to validate on more batches because we have less data. Reasons for the Three Batches? The conventional reason for choosing three batches is that quality could inadvertently get incorporated into the product during the first batch's manufacture. The quality may be regular throughout the second batch's manufacturing. The third batch's quality delivers us confidence that our technique has been validated if the same level of quality is attained, indicating that our results are reliable and consistent. It may be an incident, coincidental, or consistent occurrence if the required quality standards are met in the first batch, coincidental if the same requirements are met in the second batch, and consistent if the same standards are met in the third batch. Why not three or fewer? Conclusion There are no guidelines limiting the selection of three batches for validation; the intention of using three batches is to provide more reproducible statistical data. #analyticalchemistry #pharmaceutical #regulatorycompliance #validation #pharmaceuticalindustry #manufacturingexcellence #

2 Days Away: LighthouseAI is hosting the webinar, How to Avoid 5 Common Mistakes When Compiling a List of Required State Licenses, this Thursday, July 25th at 1:00 pm ET. Learn about the 5 most common mistakes state licensing professionals make while compiling a list of required licenses for a facility. Register Now: https://lnkd.in/eeGDCTyW #PharmaSolutions #LighthouseAI #Webinar #StateLicensing #Compliance #Regulatory #Pharma #Pharmaceutical 

2 Days Away: LighthouseAI is hosting the webinar, How to Avoid 5 Common Mistakes When Compiling a List of Required State Licenses, this Thursday, July 25th at 1:00 pm ET. Learn about the 5 most common mistakes state licensing professionals make while compiling a list of required licenses for a facility. Register Now: https://lnkd.in/eeGDCTyW #LighthouseAI #Webinar #StateLicensing #Compliance #Regulatory #Pharma #Pharmaceutical 

[On-Demand Webinar]: LighthouseAI recently hosted, How to Avoid 5 Common Mistakes When Compiling a List of Required State Licenses. Watch this on-demand webinar to learn about the 5 most common mistakes state licensing professionals make while compiling a list of required licenses for a facility. Watch Now: https://lnkd.in/eEjZchXn #LighthouseAI #Webinar #StateLicensing #Compliance #Regulatory #Pharma #Pharmaceutical 

🌡️🔬💡 If your business operates under FDA 21-CFR Part 11 Compliance, consider the data loggers and monitoring systems that we offer for your pharmaceutical, healthcare, or food production needs. The software included enables these solutions to meet regulatory requirements, ensuring the safety and security of your products and processes! Learn More:https://lnkd.in/etf5ETWF #DataLogger #Monitoring #MonitoringSystems #FDACompliance #QualityAssurance #RegulatoryCompliance #FDA21CFRPart11 #LifeSciences #Pharmaceutical #FoodProduction #CASDataLoggers #Manufacturing #FoodAndBeverage #Industry

It’s not just your clinical data that’s subject to GxP regulations. Avoid making data integrity mistakes in your daily routines. Read more: https://lnkd.in/e-Hcnk-a #DataIntegrity #Pharmaceutical

[On-Demand Webinar]: LighthouseAI recently hosted, How to Avoid 5 Common Mistakes When Compiling a List of Required State Licenses. Watch this on-demand webinar to learn about the 5 most common mistakes state licensing professionals make while compiling a list of required licenses for a facility. Watch Now: https://lnkd.in/eEjZchXn #LighthouseAI #Webinar #StateLicensing #Compliance #Regulatory #Pharma #Pharmaceutical 

🔦 Customer complaint data in the pharmaceutical and medical device industries is often treated similarly to other quality systems data, such as manufacturing deviations, non-conformances, or adverse event reports. While it's essential to collect and analyze all quality-related data diligently, customer complaints deserve special attention due to the unique insights they offer. 🔍 This week, we will discuss the five reasons why you should pay attention to your customer complaint data. 📧 Message me or comment below if you would like to know more. #pharmaceutical #meddevice #datainsights #complaints #qualitysystem

Understanding air classification is key for pharmaceutical and life sciences companies to meet stringent regulatory requirements. Our services offer precise control over particle counts, safeguarding your processes and products. Partner with us for trusted guidance and dependable solutions in maintaining clean room standards. #RegulatedSectors #ProductIntegrity #CleanRoomStandards

Self-Inspections are designed to highlight any non-conformities and gaps within your business in relation to GDP so you can address them using your CAPA process, during a self-inspection it’s also good to highlight the positives you find which can be fed back into your management review meetings and could also be fed back to employees should you find a positive where 1 or more are specifically responsible to help with morale. Read More: https://bit.ly/3WBy89d #export #exporttraining #training# #GDP #reposnsibleperson #qualitymanager #logosticsmanager #medicinialproducts #pharmaceutical #pharmacy #pharmacyeducation #pharmacycourses