eu gmp annex 11 computerised systems

Cross-Site Vendor Performance Benchmarking

Cross-Site Vendor Performance Benchmarking Cross-Site Vendor Performance Benchmarking This article provides a detailed step-by-step tutorial on the validation lifecycle as it pertains to cross-site vendor performance benchmarking in compliance with EU GMP Annex 15 and related regulations. The focus is…

Visual Inspection Criteria Specific to Shared Facility Cleaning

Visual Inspection Criteria Specific to Shared Facility Cleaning Visual Inspection Criteria Specific to Shared Facility Cleaning In the pharmaceutical and biologics industries, effective cleaning processes are crucial to ensure product quality and compliance with regulatory standards. This step-by-step validation tutorial…