Papers written by members of Kaufman Flynn Consulting Services
(Click following links to download in Chinese)
- Comparison and Research of Drug GMP in China and US. Pharmaceutical & Engineering Design, 2007, 6 (28).
- Organization of URS, IQ, OQ and PQ of Pharmaceutical
Equipment. Pharmaceutical & Engineering
Design, 2008, 3 (29).
- Record Management in GMP Practice. Pharmaceutical & Engineering Design,
2012, 3 (33).
- To Ensure the URS and DQ Practical and Effective. Process, 2013, 8.
- Process Validation based on Risk Analysis. Process, 2013, 11.
- Risk Analysis for Validation Requirements. Process, 2013, 14.
- Calibration and Validation for Instrumentation. Process, 2013, 19.
- Handling GMP Regulatory Inspection from US and EU
Drug Administrative Authorities. Process,
2013, 24.
SOP templates provided by Kaufman Flynn Consulting Services
(Click following links to download in Chinese)
Internet Resources
- Lab Compliance - Free monthly newsletter.
- Cleaning Validation - Monthly memos are worth seeing.
- Microbiology Network - Mailing lists are helpful.
US Law, Regulations and Guidance
- Food, Drug & Cosmetic Act
- 21CFR search
- Orange Book
- Warning Letter
- FDA ORA Electronic Reading Room (483, etc.)
Organizations
- International Conference on Harmonization (ICH)
- International Society of Pharmaceutical Engineering (ISPE)
- AOAC International
- International Pharmaceutical Excipients Council (IPEC)