FDA update – February 15, 2011

FDA Publishes Revised Process-Validation Guidance

The Food and Drug Administration (FDA) released a revised guidance document on process validation in January 2011. The title of this guidance document is “Process Validation: General Principles and Practices”. The purpose of this revised document is to guide industry about principles and approaches which should be consider while validating manufacturing processes.

This guidance is applicable for following categories of products:

  • Human drugs
  • Veterinary drugs
  • Biological and biotechnological products
  • Finished products and Active Pharmaceutical Ingredients
  • The drug constituent of a combination (drug and medical device) product

This guidance does not cover some product categories such as Medical devices, Dietary supplements; Human tissues intended for transplantation (under section 361 of PHS Act) and Type A medicated articles and Medicated Feed.

The quality of the product cannot be assured just by testing finished product; it should be built in the product itself. Process validation is the ultimate tool which assures that the products meets its pre-specified quality. The primary aim of the new guidance is to understand significance of risk based decision making and controlling attributes based on their risk level on product. As per revised guidance, the process validation is the collection and evaluation of the data from process design stages through commercial production, which provides evidence that a process is capable of producing quality product. Hence, this revised guidance includes three stages to ensure proper process validation.

Stage 1 – Process Design: The commercial manufacturing process is defined during this stage depending on product development and scale-up activities; therefore, documenting every single activity of research and development of a product is important.

Stage 2 – Process Qualification: It is the evaluation of stage 1 (Process Design); Process qualification confirms that the capability of process to reproduce commercial manufacturing.

Stage 3 – Continued Process Verification: This stage includes collection, evaluation and ongoing monitoring of production data to assure that a process is in control. The deviation in a process should be identified and corrected to assure that process is in state of control.

Finally, this guidance document is current thinking of FDA on this topic, you can go with different approach if it satisfies and justifies applicable statues and regulations. 

You need to look over this guidance document and see what you need to assure compliance. If you need some assistance on process validations we would be available to provide you an better understanding of the requirements.

For more information on this issue you can go to the following link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf or contact mdi at info@mdiconsultants.com