Tag: validation software for pharma

PQ for SIP of Bioreactors and Fermenters

PQ for SIP of Bioreactors and Fermenters PQ for SIP of Bioreactors and Fermenters This article serves as a comprehensive guide for pharmaceutical professionals on the validation of Steam-In-Place (SIP) systems utilized in bioreactors and fermenters. It aims to provide…

Continuous vs Batch Process Considerations in Blend Uniformity

Continuous vs Batch Process Considerations in Blend Uniformity Continuous vs Batch Process Considerations in Blend Uniformity This step-by-step validation tutorial provides a comprehensive approach for pharmaceutical professionals involved in ensuring blend uniformity throughout the validation lifecycle. The focus will be…

Statistical Evaluation of Blend Sampling Data

Statistical Evaluation of Blend Sampling Data Statistical Evaluation of Blend Sampling Data This article presents a comprehensive step-by-step guide for the statistical evaluation of blend sampling data within the context of process validation in pharmaceutical manufacturing. This tutorial covers critical…

Regulatory Guidance (FDA, EMA, WHO) on Blend Homogeneity

Regulatory Guidance (FDA, EMA, WHO) on Blend Homogeneity Regulatory Guidance (FDA, EMA, WHO) on Blend Homogeneity In the pharmaceutical industry, ensuring quality through validated processes is non-negotiable. One critical aspect of pharmaceutical validation is assessing blend homogeneity. This article provides…