On January 25, 2016, this blog posted an article about some of the Guidance documents that FDA was planning to issue as new and or revised this coming year (here).  In that blog post, it was noted that an update to that post would be coming-well here it is!

Some of the other notable documents we can all be looking for this year (with a little bit of editorializing) include, by category:

Pharmaceutical Quality/Manufacturing Standards (CGMP)

  • CGMP Data Integrity Questions and Answers – This should be a very interesting document since many of the CGMP findings over the last few years have been related to data integrity issues. As I have noted previously, the FDA has not taken as an aggressive stance on data integrity issues since back in the Generic Scandal days! The MHRA has also been very active in regard to providing guidance in this area based on their findings of various issues of data integrity during their inspections. Lachman Consultants has been actively involved in data integrity training sessions and seminars recently and has been involved in assisting firms rehabilitate themselves where such problems have been uncovered.
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft – The revision of this old, often misinterpreted Guidance document hopefully will add some clarity about FDA’s stated position. I can tell you that over the years, getting a straight answer from FDA or others in industry has been like asking 10 lawyers the same question and getting 15 different answers!
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities – We are not sure whether this is more directed to compounding/outsourcing pharmacies than to just pharmacies in general, relative to repackaging. We will just have to see when it is issued!



  • Child Resistant Closures and Labeling – It’s about time the Agency addressed this issue as we believe that there needs to be standardization and understanding of labeling, as well as when and what products must be in Child Resistant containers. Many of the older ANDAs may or may notbe as consistent on this issue as we would have hoped.


Pharmaceutical Quality/CMC

  • Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information; Revised Draft – Again, another document whose updating time has finally come. Maybe we will have “one quality voice” on this issue after the revised Guidance hits the street. 
  • Drug Master Files; Revised Draft – Given the age of the last DMF guidance document, it will be nice to welcome its grandson to the table.
  • In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products – Another in a series of important Guidance documents on abuse deterrent products for which the entire industry needs clarity. 
  • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft – What can I say – have you seen many generic MDIs or DPI? Didn’t think so. We need all the Guidance we can get and certainly one that reflects current Agency thinking.
  • Microbiological Quality Consideration in Non-Sterile Drug Product Manufacturing – Here is another issue that has been as clear as mud. Perhaps this will set the ship straight.
  • Regulatory Classification of Pharmaceutical Co-Crystals; Revised Draft – I don’t know about you, but when I read the original Guidance I thought, “what did they just say?”
  • Use of the FDA Inactive Ingredient Software (IID) – The IID has put many regulatory affairs professionals and formulators into a 12-step program. Are we getting close to some meaningful revisions?
  • Quality Attribute Considerations for Chewable Tablets – Given the interest in pediatric patients and the elderly, or patients with dysphagia, having additional clarification on this issue and defining what the dosage form really is will be a big help.


Well, that’s it for now.  Just keep your eyes peeled throughout the year for these and many other documents not specifically covered in this blog.  The full list can be found here.