| Topic : Steps in making manufacturing profitable |
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Regulatory Compliance Management in life sciences industry
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Source : http://www.focusedonmetals.com
Activity:
2 comments
335 views
last activity : 11 29 2010 06:35:36 +0000
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Although specific regulations governing pharmaceutical production are often not feasible when dealing with novel technologies, GMP guidelines establish best practices as they evolve and also provide for extensive record keeping that helps reviewers determine the best way to make a drug. Manufacturers turn to GMP guidelines for direction on how best to perform laboratory processes such as calibrating instruments, preventing contamination, verifying drug stability, and labeling pharmaceutical products.
The FDA has defined current GMPs in 21 CFR 210 and 211. These mandates require drugs to meet quality, potency, and purity standards. In addition to delineating the required characteristics of drugs, GMPs also mandate specialized training and lab environmental controls such as instructions for ensuring freedom from vermin, instructions for how to build and maintain clean rooms, directives on how to house and handle lab animals, and strict policies for compliance.
For manufacturing and other guidelines refer to the link http://www.fda.gov/cder/Guidance/index.htm#newly_added
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Good one suresh...... very informative.... :) |
We have used this kind of tactics earlier also by using messages, warnings and many things in tobacco and cigarette packets. He who is concerned about his health has left intoxicating but the addicted had no effect on them. So, we can be sure of one... |
I think it will take time for the rural market to accept the product. The product should appeal the customers the price should be affordable. It should be easily accessible by people from all the segments of the society they should be informed about... |