ISPE Regulatory Committees and Groups

ISPE’s Regulatory Committees and Groups bring visibility and solutions to major challenges faced by the industry with regard to regulatory/quality aspects and ensure  ISPE members have access to the latest regulatory developments and expectations.

Standing Committees

Regulatory Steering Council (RSC)

Establishes ISPE’s global regulatory priorities and strategy in alignment with the direction of the ISPE Strategic Plan.

Regulatory Quality Harmonization Committee (RQHC)

Provides ISPE with intelligence and identifies opportunities for ISPE to provide input, guidance, and scientific/technical support on evolving regulatory issues and concerns. The management body, which is referred to as “RQHC Global,” provides direction and oversight to the Regional Focus Groups.

RQHC Regional Groups: Asia-Pacific, EMEA, Latin America, North America.

Initiative Teams

Advancing Pharmaceutical Quality (APQ)

Advances quality in all sectors of the pharmaceutical industry via a quality maturity program aligned with ICH Q10 via ISPE products and services. Identify systematic approaches, tools and education necessary to assure reliable manufactured product quality. More about ISPE’s APQ Program

Drug Shortages

Provides guidance, tools, and education to assist companies and support regulatory collaboration in the prevention and mitigation of drug shortages. Work toward harmonization of expectations. More about ISPE’s Drug Shortages Initiative

Product Quality Lifecycle Implementation (PQLI)®

Integrates science and regulatory approaches for advancing manufacturing science and pharmaceutical quality across the product lifecycle. Develop solutions in emerging regulatory and scientific topics related to CMC and GMP approaches to ensuring product quality. Lean more about PQLI

How You Can Get Involved