Institute of Good Manufacturing Practices India
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Yearly List of New and revised draft guidances published by The U.S. Food and Drug Administration (FDA)

The yearly list of new and revised draft guidances had been published by The U.S. Food and Drug Administration (FDA). A total of 102 planned guidance documents have been published out of which some have been carried forward from 2015 such as documents on the drug supply chain security act, on biosimilars..

The guidances have been categorized under 15 different themes. Out of 15 three documents have been listed under the category of “Pharmaceutical Quality /Manufacturing Standards (CGMP)".as listed below:


• CGMP Data Integrity Questions and Answers (already listed 2015)
• Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
• Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities (already listed 2015)


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