FDA publishes List of Guidances planned for 2015

At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. The list is subdivided into different categories. It contains for example also guidances planned in connection with the topics Clinical Pharmacology or Clinical/Statistical.

CGMP is a category of its own for which "only" three new guidances are planned for 2015: 

  • A questions & answers (Q&A) paper on the topic data integrity 
  • CGMP rules for outsourced facilities (pharmacy compounding) 
  • Rules for the repackaging of certain drug products by pharmacies and outsourcing facilities

Especially the Q&A document could be interesting.
The guidances planned for the category "Pharmaceutical Quality/CMC" are also closely related to GMP. The following guidances are examples of the 13 guidances planned altogether in this category:

  • A guidance on the development of NIR procedures 
  • A guidance on microbiological quality considerations in non-sterile drug product manufacturing
  • A guidance on quality metrics and risk-based inspections.

Concerning biotechnology specifically there are two separate categories with the topics biopharmaceutics and biosimilarity.

Conclusion: The number of new guidances in the GMP environment planned for 2015 is relatively limited but some of the topics (such as data integrity and quality metrics) could be very interesting. Furthermore, it remains to be seen if all of the planned guidances will really be published in 2015.

Please also see the "New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015".

Postscript: If you are interested in the topic quality metrics: In the framework of the 6th European GMP-Conference the ECA offers a Pre-Conference on this topic taking place in Heidelberg on 8 June 2015.

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