Overview of
USFDA Audits – Inspections, Expectations & Readiness
in Pharmaceutical Industry
By
P. MUTHURAJ
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Agenda
US-FDA Inspection – Introduction
US FDA – Types of Inspections
US FDA – Inspection Tool & It’s Level
US FDA – Compliance Expectations / Inspection Check List
US FDA – Inspection Process Flow / Inspection Classifications
US FDA - Inspection : Key Factors that Increase Inspection Frequency
US FDA – Inspection : Reasons for the Observations / Failures
US FDA / MHRA – Warming Letter / Deficiencies
US FDA – Form 483 and Warning Letter Issued Key Areas Deficiencies - Statistical Report
( 2017 – 2020 )
US FDA – Inspection Behavioral Approach & Takeaway Learning
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US FDA Inspections – Introduction
The Food and Drug Administration (FDA) is responsible for protecting the public health by
assuring : Safety, Efficacy, and Quality of human and veterinary drugs, biological
products, medical devices, cosmetics, and products that emit radiation.
The primary objective of inspections :
Helps ensure that every single product or component meets Regulatory standards or
requirements.
Lead to improved Quality control testing & ensure the Quality of the Drug Product
entering to Market
Helps in reducing the time to market by eliminating manufacturing defects. 3
US FDA – Types of Inspections
Pre-Approval Inspections – Before approving any New drug, FDA checks: if any
Methods / Facilities are complying the regulations.
Routine Inspections – Surprise Inspections happen to Ensure ongoing compliance
(every 2 years once). Inspection Follow a Method known as QSIT
Compliance Follow-up Inspections - To verify compliance and/or corrective actions in
the wake of previous violative inspections, violative samples, or following official
agency action, form 483 / Warming Letter
For Cause Inspection - focus mainly on the specific issue mentioned, though their
findings could prompt additional inspections into other parts of the operation.
E.g. due to Product recall, Complaints, etc.
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US FDA – Inspection Tool & It’s Level
Quality System Inspection Technique (QSIT)
consists 4 systems :
1. Management Control
2. Design Control
3. CAPA
4. Production and Process Control
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US FDA – Compliance Expectations
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US FDA – Inspection Check List
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US FDA – Inspection Process Flow
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US FDA – Inspection Classifications
Examples Implications
Implications Examples Implications
Examples
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US FDA - Inspection : Key Factors that Increase
Inspection Frequency
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US FDA - Inspection : Reasons for the
Observations / Failures
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US FDA / MHRA – Warming Letter / Deficiencies
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US FDA – Form 483 and Warning Letter Issued in Pharma
Key Areas Deficiencies - Statistical Report ( 2017 – 2020 )
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US FDA – Inspection Behavioral Approach &
Takeaway Learning
A. Keep Calm and Professional:
During Inspection Process, the personnel should be calm and professional.
Don’t argue or dispute with the FDA inspectors. Instead, provide proper information.
Avoid false information, Clear in the Statement
B. Note the Observations:
Keep a note of the officer’s observations and any deficiency found.
All the issues identified in the inspection process will have to be addressed and
corrected without delay.
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US FDA – Inspection Behavioral Approach &
Takeaway Learning
C. Be Open Minded and Cooperate:
The FDA inspector should be provided with all the requested information.
Honesty and Transparency breed trust.
D. Learning and Takeaway from Inspection Observations:
An FDA inspection should be considered a learning experience
Things to see the areas where your approach or methods may need improvement.
Leverage the learnings to strengthen your organization’s compliance.
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Seminar – Significance?
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Seminar – Really Impact?
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Seminar – FDA Audits: Inspections, Expectations &
Readiness
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