Tag: Cleaning in Shared Facilities

Establishing MACO and PDE Values for Shared Equipment

Establishing MACO and PDE Values for Shared Equipment Establishing MACO and PDE Values for Shared Equipment Step 1: Understanding the Basics of MACO and PDE The determination of Maximum Allowable Carryover (MACO) and Permissible Daily Exposure (PDE) values is critical…

Validating Shared Equipment Across Potent and Non-Potent Products

Validating Shared Equipment Across Potent and Non-Potent Products Validating Shared Equipment Across Potent and Non-Potent Products In the pharmaceutical industry, ensuring the safety and efficacy of products manufactured in shared facilities is paramount. The validation of shared equipment used for…

Setting Worst-Case Product and Equipment for Cleaning Validation

Setting Worst-Case Product and Equipment for Cleaning Validation Setting Worst-Case Product and Equipment for Cleaning Validation Cleaning validation is a critical aspect of the pharmaceutical production process, particularly in shared facilities where cross-contamination poses a significant risk. This article offers…

Cross-Contamination Risk Assessment in Shared Facilities

Cross-Contamination Risk Assessment in Shared Facilities Cross-Contamination Risk Assessment in Shared Facilities Step 1: Understanding User Requirements Specification (URS) and Risk Assessment In the context of pharmaceutical validation, the User Requirements Specification (URS) acts as the foundational document that delineates…

Product Changeover Cleaning SOP: Step-by-Step Guide

Product Changeover Cleaning SOP: Step-by-Step Guide Product Changeover Cleaning SOP: Step-by-Step Guide 1. Understanding User Requirements Specification (URS) and Risk Assessment Creating an effective cleaning validation program begins with a comprehensive User Requirements Specification (URS) that outlines expectations and requirements…

Cleaning Validation in Multi-Product Pharma Facilities

Cleaning Validation in Multi-Product Pharma Facilities Cleaning Validation in Multi-Product Pharma Facilities The validation lifecycle in pharmaceutical manufacturing is critical to ensuring the efficacy and safety of both products and the processes involved. This article will serve as a comprehensive…