Guidance for Industry — Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice – September 2004. See also the draft guidance on investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
FDA Compliance Policy Guide Sec. 130.300, FDA Access to Results of Quality Assurance Program Audits and Inspections, (CPG 7151.02) http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg130-300.html
ANSI/ISO/ASQ Q9001-2000: Quality management systems – Requirements (American Society for Quality, 2000)
ANSI/ISO/ASQ Q9004-2000: Quality management systems – Guidelines for performance improvement (American Society for Quality, 2000)
ANSI/ISO 17025-1999: General requirements for the competence of testing and calibration laboratories (American Society for Quality, 1999)
CMMI-SE/SW, V1.1: Capability Maturity Model Integration for Systems Engineering and Software Engineering, Staged Representation (Software Engineering Institute, Carnegie Mellon University, 2002) http://www.sei.cmu.edu/pub/documents/02.reports/pdf/02tr002.pdf
Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (U.S. Department of Health and Human Services/ Food and Drug Administration, August 2001) .
Variation Risk Management – Focusing Quality Improvement in Product Development and Products by Anna C. Thornton (John Wiley and Sons, Inc.; Hoboken, New Jersey, 2004
Руководство для промышленности – Представление документации по валидации процесса стерилизации при регистрации лекарственных препаратов для человека и ветеринарных медикаментов) Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products – http://www.fda.gov/cder/guidance/cmc2.pdf
Глава 3, «Управление качеством в американской фармацевтической отрасли, Фармацевтическое качество» («Quality Management in the American Pharmaceutical Industry, in Pharmaceutical Quality», под редакцией R. Prince (DHI Publishing, River Grove, IL, 2004)