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cGMP Defined

  
 
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cGMP Defined



 

Note regarding links on this page:  These links lead to HTML versions of these documents for ease of navigation.  Better formatted PDF versions are usually also available on the FDA site, if you would prefer this format.  
    

 

 
CGMP are the Current Good Manufacturing Practices followed by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity.  FDA regulates these industries to ensure CGMPs are being followed by using the following tools:
bulletCGMP regulations:   Laws which can incur criminal penalties when they are not  followed; for example:
bullet21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part 
bullet21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
bullet21 CFR Part 600 - Biological Products: General
bullet21 CFR Part 11 - Electronic Records; Electronic Signatures

 

bulletFDA Guidance Documents (CDER and CBER): Formal documents representing the Agency's current thinking on a particular subject.  Though guidelines are not legally binding, non-compliance may still lead to FDA actions.  Alternate procedures and practices may also be acceptable but they must be carefully justified and adopting them presents a certain risk. These documents usually contain much more detail and "how to" information than FDA regulations.  For example:
bulletGMPs for Bulk Drugs:  Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients 
bulletStability Testing:  Q1A(R) Stability Testing of New Drug Substances and Products
bulletValidation of Analytical Procedures
bulletQ2A Text on Validation of Analytical Procedures
bulletBioanalytical Method Validation
bulletAnalytical Procedures and Methods Validation
bulletGuideline on General Principles of Process Validation 
bulletPoints to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use 
bullet

Guide To Inspections Validation Of Cleaning Processes

bulletPlus many, many more.  Full listings: CDER and CBER.

 

Please visit our Document Library for a full list of helpful FDA documents as well as many others from other regulatory agencies and industry groups.

The GMP Institute, a division of ISPE, has published a more detailed explanation about GMPs that is very helpful.

 

 

The GMP Continuum 
During Drug Development
The FDA considers the GMPs to be a "sliding scale", meaning that they must be more rigorously applied as products move forward in development.  In other words, during manufacture of Phase I material less detailed application of the regulations will be expected.  By the time a product reaches Phase III Clinical trials, GMPs are expected to be fully followed during manufacturing.  

"CGMPs that develop with clinical studies, examples:  process validation (e.g. manufacturing, cleaning and sterilization), methods validation, and process controls (e.g., in-process testing and specifications)."  

Mary Malarkey
CBER, FDA
May, 2000


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