Other Publications

Concept Papers

Concept Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. These papers may interpret or clarify a regulatory position, and may seek to influence. View all Concept Papers.

Discussion Papers

Discussion Papers promote discussion and creates awareness on new or emerging topics; they often solicit feedback, gauge interest, and seek member or industry input. They may state a problem, provide the tentative exploration of solutions and options, and may suggest potential next steps. View all Discussion Papers.

GMP Mini Regulation Handbooks

These handy pocket-size booklets are an ideal way to keep everyone informed of FDA regulations and guidelines.  See all GMP Mini Regulation Handbooks.

21 CFR Part 11: Electronic Signatures

21 CFR Part 111: Dietary Supplements

21 CFR Part 210 & 211: Pharmaceutical

ICH Q10: Quality Systems

ICH Q11: Development and Manufacture of Drug Substances

ICH Q7A: Active Pharmaceutical Ingredients

ICH Q8R2: Pharmaceutical Development

ICH Q9: Quality Risk Management

Initiative Reports and Tools

Drug Shortages Publications & Tools

ISPE Quality Metrics Initiative: Wave 1 Report

ISPE Quality Metrics Initiative: Wave 2 Report