Full compliance with FDA cGMP
Based on the following key standards and guidelines:
Based on the following documentation hierarchy:
AccelPharms's facilities and processes will implement using a QbD risk-based approach (FDA Process Validation 2011, ICH Q8, ICH Q9, ICH Q10, GAMP, ISPE Commissioning & Qualification Baseline, 21 CFR 211 and EU GMP regulations) within a Defined Life Cycle (ASTM E2500) for implementation, qualification and validation of process and facilities.
This approach uses the highest quality and compliance standards. The facility and process implementation, qualification, validation, and revalidation are based on the following hierarchy:
Please do not hesitate to contact us with any inquiries