The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has published a Guidance Agenda with planned new and revised Draft Guidances for the calendar year 2017. Amongst these documents are a few which might be interesting for the GMP area, for example:
Bioanalytical Method Validation; Revised Draft
Container Closure Systems for Packaging Human Drugs and Biologics; Revised Draft
Drug Master Files; Revised Draft
Visual Inspection of Injectable Drug Products
Current Good Manufacturing Practice for Medical Gases; Revised Draft
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
Field Alert Report Submission
Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities