ССЫЛКИ

  1. 1978 Preamble to the Good Manufacturing Practice Final Regulations – Federal Register Docket No. 73N-0339] http://www.fda.gov/cder/dmpq/preamble.txt  
  2. CPGM 7356.002 Compliance Program – Drug Manufacturing Inspections http://www.fda.gov/cder/dmpq/compliance_guide.htm
  3. Quality Planning and Analysis, 3rd Ed. by J.M. Juran, F.M. Gryna (McGraw-Hill, New York, N.Y. 1993)
  4. ANSI/ISO/ASQ Q9000-2000: Quality management systems – Fundamentals and vocabulary, (American Society for Quality, 2000)
  5. Guideline of General Principles of Process Validation, May 1987 – http://www.fda.gov/cder/guidance/pv.htm
  6. FDA Compliance Policy Guide 7132c.08 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval, updated 03-12-2004 – http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg490-100.html
  7. 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 See also the draft guidance on investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
  8. 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
  9. Criteria for Performance Excellence, Business (Baldrige National Quality Program, NIST 2003) http://baldrige.nist.gov/PDF_files/2003_Business_Criteria.pdf
  10. ANSI/ISO/ASQ Q9001-2000: Quality management systems – Requirements (American Society for Quality, 2000)
  11. ANSI/ISO/ASQ Q9004-2000: Quality management systems – Guidelines for performance improvement (American Society for Quality, 2000)
  12. ANSI/ISO 17025-1999: General requirements for the competence of testing and calibration laboratories (American Society for Quality, 1999)
  13. 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
  14. The Balanced Scorecard Institute: http://balancedscorecard.org
  15. Guidance for Developing Quality Systems for Environmental Program (EPA QA/G-1, Nov 2002) http://www.epa.gov/quality/qs-docs/g1-final.pdf
  16. 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) .
  17. Good Manufacturing Practices for Pharmaceutical Products: Main Principles (World Health Organization Technical Report Series, No. 908, 2003) http://www.who.int/medicines/library/qsm/trs908/trs908-4.pdf
  18. Procedures For The Implementation of The Federal Managers’ Financial Integrity Act (FMFIA); (FDA Staff Manual Guide 2350.1)
  19. Managing the Risks from Medical Product Use: Creating a Risk Management Framework (U.S. FDA, 1999) http://www.fda.gov/oc/tfrm/1999report.html
  20. Framework for Environmental Health Risk Assessment – Final Report, Vol.1 (Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997) http://www.riskworld.com/Nreports/1997/risk-rpt/pdf/EPAJAN.PDF
  21. Report on FDA Quality System Framework for Pharmaceutical Product Regulation Activities; (Quality System Framework Subcommittee, December 2003)
  22. Tutorials for Continuous Quality Improvement (Clemson University, 1995) http://deming.eng.clemson.edu/pub/tutorials/
  23. Variation Risk Management – Focusing Quality Improvement in Product Development and Products by Anna C. Thornton (John Wiley and Sons, Inc.; Hoboken, New Jersey, 2004
  24. 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
  25. 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)