The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.
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| May 28, 2013 By: Patricia Van Arnum |
FDA has issued draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which describes the agency’s current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in contract cGMP manufacturing of drugs.
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DRUG REGULATORY AFFAIRS INTERNATIONAL 