Tag: dry transfer western blot

Examples of KPI Trends in 483 Observations

Examples of KPI Trends in 483 Observations Examples of KPI Trends in 483 Observations In the pharmaceutical and biotech industries, ensuring compliance with regulatory standards is essential. In particular, understanding how to navigate the intricacies of process validation is critical…

Role of Artificial Intelligence in CPV Pattern Recognition

Role of Artificial Intelligence in CPV Pattern Recognition Role of Artificial Intelligence in CPV Pattern Recognition The pharmaceutical industry faces immense pressure to validate processes reliably and consistently while complying with strict regulatory expectations. Continued Process Verification (CPV) is a…

Environmental Monitoring Systems (EMS) Qualification in Grade A/B

Environmental Monitoring Systems (EMS) Qualification in Grade A/B Environmental Monitoring Systems (EMS) Qualification in Grade A/B Ensuring the integrity of sterile products is paramount in the pharmaceutical industry. Environmental Monitoring Systems (EMS) play a crucial role in maintaining aseptic conditions…

EMA Annex 15 and Its Role in Revalidation Protocol Design

EMA Annex 15 and Its Role in Revalidation Protocol Design EMA Annex 15 and Its Role in Revalidation Protocol Design The pharmaceutical and biologics industry continuously evolves to address stringent regulatory requirements and the rising need for quality assurance. In…

Gap Assessment Tools for ICH Q9 Readiness

Gap Assessment Tools for ICH Q9 Readiness Gap Assessment Tools for ICH Q9 Readiness As pharmaceutical and biologics organizations strive for compliance with the evolving regulatory landscape, understanding the requirements of ICH Q9 becomes vital. This article provides a comprehensive,…

SST Results Trending and Control Charting in QC Labs

SST Results Trending and Control Charting in QC Labs SST Results Trending and Control Charting in QC Labs In the pharmaceutical and biopharmaceutical industry, ensuring the reliability and robustness of analytical methods is critical for regulatory compliance and product quality.…

Steam-in-Place (SIP) Cycle Validation: Critical Parameters

Steam-in-Place (SIP) Cycle Validation: Critical Parameters Steam-in-Place (SIP) Cycle Validation: Critical Parameters Validation of steam-in-place (SIP) cycles is a critical aspect of process validation within pharmaceutical and biologics manufacturing. This comprehensive step-by-step guide focuses on the important parameters to consider…

Real-Time Monitoring Tools for Blend Uniformity (eg, NIR)

Real-Time Monitoring Tools for Blend Uniformity (eg, NIR) Real-Time Monitoring Tools for Blend Uniformity (eg, NIR) Achieving blend uniformity is crucial in the pharmaceutical manufacturing process, as it ensures that active ingredients are evenly distributed throughout the product. This article…