Pda Technical Report 90 May 2026

While Annex 1 mandates the what (a holistic, risk-based CCS), it leaves significant room for interpretation on the how . Enter , titled "Development and Application of a Contamination Control Strategy (CCS) for Drug Product Manufacturing."

Introduction: A New Era of Aseptic Processing In the pharmaceutical industry, few documents have reshaped facility design, operational philosophy, and regulatory inspection readiness as profoundly as the EU GMP Annex 1 revision (2022). At the heart of this groundbreaking regulation lies a single, non-negotiable requirement: the Contamination Control Strategy (CCS) . pda technical report 90

Published by the Parenteral Drug Association (PDA), TR-90 serves as the essential industry guide for designing, implementing, and maintaining a compliant CCS. It bridges the gap between high-level regulatory expectations and practical, day-to-day execution. Released in 2023, PDA TR-90 is a comprehensive, 100+ page technical document that provides a structured framework for developing a CCS. It is not a regulatory standard, but rather a consensus-based industry best practice guide . The report synthesizes input from global regulators, industry experts, and technology suppliers. While Annex 1 mandates the what (a holistic,

Every sterile drug product manufacturer should designate a CCS owner, purchase PDA TR-90, and conduct a gap assessment within the next six months. The cost of non-compliance is far greater than the investment. About the Author: This article is based on PDA’s published Technical Report No. 90 (2023). For the full report, including case studies and detailed risk assessment tables, visit the PDA bookstore. Published by the Parenteral Drug Association (PDA), TR-90