Basic
This guidance aligns process validation activities with a product lifecycle concept and with
existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH)
guidances for industry,
Q8(R2) Pharmaceutical Development,
Q9 Quality Risk Management, and
Q10 Pharmaceutical Quality System.2 Although this guidance does not repeat the concepts and
principles explained in those guidances, FDA encourages the use of modern pharmaceutical
development concepts, quality risk management, and quality systems at all stages of the
manufacturing process lifecycle
Approach to Process Validation
Stage 1 – Process Design: The commercial manufacturing process is defined during this
stage based on knowledge gained through development and scale-up activities.
• Stage 2 – Process Qualification: During this stage, the process design is evaluated to
determine if the process is capable of reproducible commercial manufacturing.
• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine
production that the process remains in a state of control.
Process Validation: General Principles and Practices
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.