The Analytical Chemistry Springboard
Good Laboratory Practice [GLP] and Good Manufacturing Practice [GMP]
- A Guide to Good Laboratory Practices for Students
This link contains pages for chemistry students pages on useful topics such as: "Basic Laboratory Safety Rules", "How to Prepare for Laboratory Experiments", "How to Write a Good General Chemistry Laboratory Report" and "Tips for Organic Laboratory Experiments".
- A Practical Guide to Analytical Method Validation
"Doing a thorough method validation can be tedious, but the consequences of not doing it right are wasted time, money, and resources." The link leads to is complete text of an article by J. Mark Green which appeared in Analytical Chemistry 1996, 68, 305A-309A.
- Collaborative Electronic Notebook Systems Association
This site collects pertinent information on collaborative computing and electronic recordkeeping systems for scientific and technical purposes. It covers software, hardware and standards systems.
- Current Good Manufacturing Practices
This site helps you access the cGMPs and provides a special emphasis on the drug cGMPs.
- FDA - GMP820.60/61
This is an excerpt from he complete good manufacturing practice documentation of the U.S. Food & Drug Administration.
- FDA Cosmetics Handbook
This page handbook contains valuable information on FDA's requirements and policies for safe production and accurate labeling of cosmetics. The material in it has been carefully selected for use in the production and distribution of cosmetic products.
- FDA Guidance Documents
Guidance documents represent FDA’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office. Most documents are in Adobe Acrobat format. This area will reorganized and largely expanded to hundreds of guidance documents.
- FDA Regulatory Procedures Manual
This hypertext appears to cover the entire title manual.
- Genetic Manipulation Advisory Committee Guidelines
These Australian pages contain regulatory guidelines for genetic manipulation work on a small and large scale, as well as guidelines for the planned release of genetically manipulated organisms.
- Good Automated Laboratory Practices
An EPA handbook available in Adobe PDF format. If this link fails, the file should also be available at this FTP site.
- Good Laboratory Practice Online
This commercial site has lots of useful information, mostly gathered in the Resources Pages.
- Good Manufacturing Practice - Validation Guidelines [Seems to be gone off the web!]
How to validate a pharmaceutical process according to GMP.
- OECD Principles of GLP
The OECD Principles of GLP were first published in 1982 in Good Laboratory Practice in the Testing of Chemicals (OECD, 1982, out of print). This publication also contained guidance provided in the final report of the Expert Group. Since the early 1980's OECD has continued to elaborate and refine this guidance, and has undertaken further work on national and international aspects of compliance with the GLP Principles and monitoring of such compliance. The results of that work are being published (or reprinted) in this OECD Series on Good Laboratory Practice and Compliance Monitoring, beginning in 1991. It is therefore appropriate that the OECD Principles of GLP and the Council Acts concerning GLP be the subject of this first number of the series.
- Society of Quality Assurance - Regulatory Reviews
This index was originally prepared by Donald E. Mayer and Thomas W. Purdue as a poster presented at the 1995 Society of Quality Assurance annual meeting in Phoenix, AZ. This index has been reprinted and modified for the Internet with permission of the authors by Michael E. Mispagel.
- Spectroscopy, Radiometry, Photonics, Quality and Validation Resource Center
"Your central Internet Resource for information on spectroscopy, radiometry, photonics, electro-optics, quality management and standarization compliance."
- U.S. Pharmacopeia
USP is the worldwide standard for drug information and source of drug standards. This home page contains links to their Publications Catalog with a comprehensive collection of print and electronic products, the Reference Standards Catalog containing the world's largest collection of pharmaceutical reference standards, the Practitioner's Reporting Network, and more.
Welcome visitor since 1996-03-08.
Last modified Thu Feb 03 09:19:26 2000 by firstname.lastname@example.org - Data is 7481 bytes
Knut Irgum, Analytical Chemistry, Umeå University, S-901 87 Umeå, Sweden.
© Copyright, Knut Irgum, 1995-2000. All rights reserved.