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News about GMP/cGMP

2017-01-17

CDER List for 2017 Guidance Documents

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to publish in 2017. A total of 102 planned guidance documents have been set out.

 

The guidances are categorized in 16 different themes.

Three documents are listed under the category „Biosimilarity“:

  • Considerations in Demonstrating Interchangeability With a Reference Product
  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Under the category „Pharmaceutical Quality/Manufacturing Standards (CGMP)“ can be found 4documents:

  • Current Good Manufacturing Practice for Medical Gases; Revised Draft
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft (already listed 2016)
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities (already listed since 2015)

The related category „Pharmaceutical Quality/CMC” lists 11 additional guidances:

  • CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports
  • Container Closure Systems for Packaging Human Drugs and Biologics; Revised Draft
  • Drug Master Files; Revised Draft
  • Drug Products, Including Biological Products, That Contain Nanomaterials
  • GDUFA II Priority ANDA Pre-Submission Communications
  • Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
  • In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
  • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft
  • Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software
  • Use of the FDA Inactive Ingredient Software (IID)
  • Visual Inspection of Injectable Drug Products
If you are interested to take a look at the full list of guidances, please click here.

Source:

FDA: CDER list

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Literature recommendation
GMP Fundamentals – A Step-by-Step Guide (download)
GMP Compliance Adviser
Single User Licence (monthly subscription)
Microbiological Monitoring in Pharmaceutical Manufacturing