FDA Publishes Guidance Agenda for the Coming Fiscal Year 2007

 
Every year, the FDA publishes a Guidance Agenda. It lists documents that the FDA intends to publish in the next fiscal year.

This year's list includes a number of interesting initiatives:

In the field of biologics (CBER):

• Design, Operation, and Validation of Heating, Ventilation, and Air Conditioning (HVAC) Systems Used in the Manufacture of Products Regulated by the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
• Validation of Rapid Microbiological Methods for Assessing Sterility of Cellular and Gene Therapy Products.
• Characterization and Qualification of Cell Substrates and Other Biological Starting Materials for the Production of Viral Vaccines.
• Changes to an Approved Application: Biological Products.

In the field of veterinary drug products (CVM):

• Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA.

In the field of drug products/chemistry (CDER):

• Quality by Design.
• Process Validation: General Principles and Practices.
• Penicillin as Defined in the CGMP Regulation under 21 CFR 211 and Separation Requirements for Manufacturing.

What will certainly also be interesting is the Guidance "Importation of Active Pharmaceutical Ingredients". Another remarkable fact is that the FDA plans to issue a guidance on Quality by Design. Since documents that are being harmonised through the ICH process are marked in the list, it seems as though the FDA wanted to publish a guidance in addition to the document ICH Q8.

The pharmaceutical industry has been waiting a long time for the review of the guidance on process validation: general principles and practices. Now that the corresponding Compliance Policy Guide (CPG) has been adapted, this document is overdue. According to the information in hand, the guide will continue the new risk-based implementation (among other things waiving the 3 magic validation runs) in a consistent way.

On the whole, one can say that the FDA stays on the course of the cGMP for the 21st Century Initiative (http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm).
  

GMP Events with FDA Speakers!

At the following events in Europe, you have the opportunity to discuss the implementation of the different requirements directly with official FDA representatives:

Conference organised by APIC/CEFIC:
9th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Prague, Czech Republic, 9-11 October 2006
FDA speakers: Dr Moheb Nasr, Grace McNally
www.api-conference.org

Conference organised by ECA:
Setting Specifications and Stability Testing, Berlin, Germany, 23-25 October 2006
FDA speaker: Dr Norman R. Schmuff

The following ECA events also deal with FDA compliance:

• FDA Compliance in Analytical Laboratories
  Prague, Czech Republic, 4-6 October 2006
• How to Pass EU and FDA Inspections - GMP-Compliance Auditor
  Barcelona, Spain, 4-6 October 2006
• GMP and FDA Compliance in Quality Assurance Units
  Prague, Czech Republic, 8-10 November 2006
• Successful HPLC Management in a GMP-/FDA-Regulated Environment
  Prague, Czech Republic, 22-23 November 2006

 
Author:
Oliver Schmidt
On behalf of ECA

Source: Guidance Agenda http://www.fda.gov/OHRMS/DOCKETS/98fr/oc0689.pdf