안녕하세요. GMPSchool입니다.

FDA에서 새롭게 개정된 GMP Guidance 초안이 2017년에 발간될 예정입니다.
다음의 원문과 링크를 참고하시기 바랍니다.

-------------------------------------------------------------------------------------------------------------

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

The items of the Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 reflect draft and revised draft guidances under development as of the date of FDA's posting. So there might be more to come.