News about GMP/cGMP

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