Validations: Equipment Parity / Non-Parity Justification
Filtration & Sterilization Parity: DP Curves, Integrity, and Cycle Design Filtration & Sterilization Parity: DP Curves, Integrity, and Cycle Design In the pharmaceutical industry, ensuring a robust validation process for filtration and sterilization is imperative for compliance with regulatory standards set forth by agencies such as the FDA, EMA, and MHRA. This tutorial serves as a comprehensive step-by-step guide for…
Automation/Controls Parity: PLC/SCADA Versions and Alarm Strategy Automation/Controls Parity: PLC/SCADA Versions and Alarm Strategy Introduction to Automation and Control Systems in Pharma In pharmaceutical manufacturing, automation and control systems play a pivotal role in ensuring product quality and compliance with regulatory standards. The integration of Programmable Logic Controllers (PLC) and Supervisory Control and Data Acquisition (SCADA) systems is essential for…
Equipment Parity Assessment: Non-Parity Decision Trees and Justifications Equipment Parity Assessment: Non-Parity Decision Trees and Justifications In the pharmaceutical industry, ensuring consistency and reliability in manufacturing processes is paramount. This is particularly true when it comes to equipment used during manufacturing — such equipment is often subject to stringent regulatory scrutiny, from entities such as the US FDA and the…
Scaling Laws in Practice: kLa, Tip Speed, Reynolds, and Residence Time Scaling Laws in Practice: kLa, Tip Speed, Reynolds, and Residence Time Pharmaceutical validation involves multiple layers of rigorous processes designed to guarantee that pharmaceutical products are produced in compliance with good manufacturing practice (GMP). In particular, the examination and control of equipment scaling laws—such as kLa (volumetric mass transfer…
Mixing & Granulation Parity: Impeller Geometry, RPM, and Fill Levels Mixing & Granulation Parity: Impeller Geometry, RPM, and Fill Levels Introduction to Mixing and Granulation in Pharmaceutical Manufacturing In the pharmaceutical industry, ensuring the quality, potency, and reproducibility of products is a key concern throughout the manufacturing process. Mixing and granulation are pivotal steps that lay the foundation for the…