March 11, 2026
USP Draft Chapters on Contamination Control Strategies (CCS): What You Need to Know
Contamination control is the cornerstone of sterile drug product manufacturing. As therapies become more complex and patient safety expectations rise, regulators and standards-setting bodies are sharpening their focus on holistic contamination control strategies. When the European Union, World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised the GMP Annex 1 guidelines for sterile medicinal products, it raised the bar on expectations of manufacturers and their sterile product suppliers, by extension. Since the publication date, several other global jurisdictions have adopted these guidelines into their national law or developed complementary requirements.
Lauren Orme
Sr. Director, Regulatory Policy and Intelligence