With 2024 coming up fast, we thought it would be good to look back at some of the more impactful changes to the quality landscape that came about this past year. Here are just some of the stories from the Lachman blog that exemplify a productive year 2023 for our industry.

 

Get Ready for a New Approach to cGMP Inspections

“…the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.”

Link: Get Ready for a New Approach to cGMP Inspections (lachmanconsultants.com)

 

Guidance on Post-Warning Letter Meetings: Will They Provide Some for Only a Special Few?

“The GDUFA III commitment letter outlined a number of industry-requested improvements to the GDUFA program. One such request related to the age-old problem of timely resolution of compliance problems resulting in a warning letter at a facility and the clearance of that warning letter.”

Link: Guidance on Post-Warning Letter Meetings (lachmanconsultants.com)

 

The Day is Here – Annex 1 Revisions Take Effect

“After many years of discussion and much preparation, today is the day the revised Annex 1 takes effect, August 25, 2023.”

Link: The Day is Here – Annex 1 Revisions Take Effect (lachmanconsultants.com)

 

New Guidance for Industry – Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

“Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both the FDA and industry are having with Nitrosamine impurities in pharmaceutical products.”

Link: Acceptable Intake Limits for NDSRIs and a New FDA Webpage (lachmanconsultants.com)

 

ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products

“CDER has issued the final guidance, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products, which provides for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM), applying to both drug substances and drug products for chemical entities, therapeutic proteins for new products, and conversion of existing products.”

Link: ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products (lachmanconsultants.com)

 

As always, all of us at Lachman wish you and yours a joyful, healthy, and prosperous New Year! We are here to serve your needs throughout the year.