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All of Bio-Link.org
Good Manufacturing Practices
Madison Community Technical CollegeCreative Ideas for Teaching GMP
By Madison Area Technical College
Biotechnology Department


GMP Table of Contents
View related websites on GMP

  What is GMP?

cGMP: The Regulatory Environment for Biological Pharmaceutical Manufacturing by Sonia Wallman New Hampshire Community Technical College

These two introductory texts describe the regulation of the pharmaceutical / biotechnology industry by the Food and Drug Administration.

  What is an SOP?

Learn about Standard Operating Procedures and why they are important in GMP. Examples of SOP's are included.

  How do you access the Code of Federal Regulations?

The Code of Federal Regulations contains documents pertaining to GMP. This section explains how to find the Regulations on-line.

  LABORATORY EXERCISE: Using Absorption Spectra for Quality Control in a Pharmaceutical Company

Perform a quality control assay on niacin, practice your spectrophotometry skills, and learn how to use an SOP.

  CLASSROOM ACTIVITY: Batch Records

Batch records are used to record important steps in the manufacturing process. This activity teaches students about batch records by having them find the errors in a poor batch record.



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Links to other information on
Good Manufacturing Practices

A Tour of FDA New on-line tutorial developed by the FDANew Item
A Tour of FDA is a multi-media web-based course offered as part of the FDA's Office of Regulatory Affairs University. This courses is a tutorial for federal, state, and local regulators as well as employees of regulated industries. It is presented in an easy to read format with on-line quizzes at the end of each section.

21CFR.com
This is a commercial site that provides regulatory information to FDA regulated industries (e.g., pharmaceutical, biotech, medical device, chemical, and food-related companies) and to regulatory professionals.

Current Good Manufacturing Practices
This site is brought to you by Learning Plus. This site focuses on "GMP training and performance solutions for healthcare manufacturers". It features documents such as "What are GMPs", "Food GMPs", and "Device GMPs". This is a good site to get information about the GMP regulations in a number of areas. Easy to use with a lot of links.

FDA CDER
FDA (Center for Drug Evaluation and Research) web site where the GMP regulations published. (21 Code of Federal Regulations Parts 210 and 211) can be found.

FDA CDER Home page
This is the government site for the FDA Center for Drug Evaluation and Research. It contains all kinds of information from consumer information to information useful for industry for new drug applications. It also contains the CDER Handbook that includes information on the New Drug Development Process.

FDA Current Good Manufacturing Practice (CGMP) Regulations
This is another FDA site that has many useful GMP Links. It is the FDA site where the Current Good Manufacturing Regulation 21 CFR as well as in-process changes and GMP Notes are found.

FDA LABORATORY PROCEDURE MANUAL
The entire FDA Procedure manual is available on this site. The Manual has chapters on everything from Laboratory accountability, Laboratory Safety as well as Training and Courtroom testimony.

FDA Office of Regulatory Affairs
This site has information related to the FDA Regulatory Affairs, the ORA laboratory, laboratory procedures, new techniques and useful analytical findings in support of FDA regulatory activities.

Food Quality Magazine
Food Quality is a online magazine "written to keep the food and beverage industry informed about the very latest technologies, techniques and legislation in food quality assurance and control." It focuses on Quality Assurance, as well as the Laboratory and Plant Operations found in the food Industry. This site has an archive of the Best of Food Quality Magazine with articles concerned with all aspects of Quality and Regulation.

GMP Institute
This is a commercial site. The GMP Institute is a consulting and training business for GMP. On this site they include many links to GMP regulatory web sites. They publish videos, training manuals and handbooks on GMP principles. They also hold workshops and training sessions.

Novation
Novation is a software supplier that makes electronic data forms and retrieval services. They are concerned with supplying forms that comply with the regulations of GMP. Some of the forms that they sell are for SOP's, Change Management as well as Batch Records.

PharmaPortal.com
This is a commercial site that publishes two industry-related magazines Pharm Tec and Pharm Exec. Both of these magazines are available on-line. This site also has a published list of Internet GMP Resources. It is divided into FDA sites, other government sites, International, Industry Publications and other sites of interest. The links are well annotated and are comprehensive.

Quality Assurance
This is the web site of The University of Georgia's Quality Assurance Unit. It includes many links to both federal sites and other sites.

Quality Assurance
This is a professional organization for Quality Assurance professionals. They are working in the areas of quality in the EPA, GLP, and GMP. "The Society of Quality Assurance (SQA) was organized to promote the quality assurance profession through the discussion and exchange of ideas and the promulgation and continued advancement of high professional standards. The members of the SQA are dedicated to promoting the highest quality and integrity in studies under their jurisdiction." Includes a certification process for quality professional.

The Regulatory Forum
This is a commercial site of AccuReg which is a regulatory and compliance consulting firm. The Regulatory forum is a site that has links to documents, new developments and a series of quizzes that deal with GMP regulation. They also have a list of good links on federal regulation within the Regulatory and Compliance Information Resource.

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