The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Facts About Current Good Manufacturing Practices (cGMPs)

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
cgmp (current good manufacturing practices), fda (food and drug administration), pharmaceuticals and pharmaceutical industry, quality, medical devices
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 4.00 average. Display Modes
  Post Number #1  
Old 30th March 2013, 10:31 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,219
Look! Facts About Current Good Manufacturing Practices (cGMPs)

http://www.fda.gov/Drugs/Development.../ucm169105.htm

Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs. This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

What are cGMPs?

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "c" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

It is important to note that cGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.
Thank You to Ajit Basrur for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 30th March 2013, 12:54 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Re: Facts About Current Good Manufacturing Practices (cGMPs)

Where does the WHO GMP stand in this. Is this WHO GMP auditable ?
  Post Number #3  
Old 30th March 2013, 01:00 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,219
Re: Facts About Current Good Manufacturing Practices (cGMPs)

Quote:
In Reply to Parent Post by somashekar View Post

Where does the WHO GMP stand in this. Is this WHO GMP auditable ?
The link is from FDA which gives info on cGMP
  Post Number #4  
Old 30th March 2013, 01:27 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Re: Facts About Current Good Manufacturing Practices (cGMPs)

Quote:
In Reply to Parent Post by Ajit Basrur View Post

The link is from FDA which gives info on cGMP
Yes. I am trying to get more information about the WHO GMP and how this will align with the FDA cGMP from a global perspective.
  Post Number #5  
Old 27th May 2013, 12:39 PM
v9991

 
 
Total Posts: 967
Re: Facts About Current Good Manufacturing Practices (cGMPs)

related interesting references at...
http://www.fda.gov/InternationalProg.../ucm114333.htm

http://www.csas.ed.ac.uk/__data/asse...maIndustry.pdf

http://rahul-regulatoryaffairs.blogs...n-fda-and.html

WHO GMP references...
http://www.who.int/medicines/areas/q...production/en/
http://apps.who.int/prequal/training...icTraining.htm
http://apps.who.int/prequal/training...modulesgmp.htm

hope this adds onto the contents...
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf ISPE_NJChHistoryGMPs.pdf (632.1 KB, 52 views)
Thanks to v9991 for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
GMP (Good Manufacturing Practices) for Wind Turbine Manufacturing and Exporting LadyOrgana Other ISO and International Standards and European Regulations 3 31st January 2012 10:10 AM
GMP (Good Manufacturing Practices) for IVD Manufacturer davidespada - 2011 ISO 13485:2016 - Medical Device Quality Management Systems 12 20th July 2010 07:12 AM
Good Manufacturing Practices (GMP) for Spices Ajayqms Food Safety - ISO 22000, HACCP (21 CFR 120) 4 7th July 2010 05:07 AM
Why "c" is small for cGMP (current Good manufacturing Practices) Ajit Basrur US Food and Drug Administration (FDA) 4 28th June 2009 08:41 AM



The time now is 02:53 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"