What are the Current Good Manufacturing Practices?
The current good manufacturing practice or cGMP are a set of standards and regulations which have been put in place by legislation to ensure high quality, safe products. The current good manufacturing practices include guidelines that protect consumers through:
- consistent, secure, precise and controlled manufacturing of products
- clear documentation of processes and tests
- a traceable history of products and procedures during the manufacturing
- records of all medicines produced for future reference in the event of recalls or adverse reactions
- an organized team in charge of assessing complaints and documenting manufacturing procedures
How will the Consent Decree for Permanent Injunction Affect Ranbaxy?
As of the mandate requested by the U.S. Food and Drug Administration, Ranbaxy must make sufficient changes to its plants in both the United States and India in order to meet standards. The FDA has prohibited certain manufacturing plants of Ranbaxy from further producing medicine until making these changes. To prevent obstructions of these principles in the future, the FDA will require Randbaxy to have their tests, data and procedures examined by an outside source to enforce integrity.
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