US FDA
21 CFR 211.34 - Consultants
Plain-language explanation, inspection context and common violation patterns.
What it says
Consultants advising on the manufacture, processing, packing or holding of drug products must have sufficient education, training and experience to advise on the subject for which they are retained, and records must be maintained stating the name, address, qualifications and type of service provided by each consultant.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- A consultant's advice does not carry independent regulatory weight simply because the consultant is qualified - the site remains fully responsible for the GMP decisions it makes based on that advice.
- Documented qualification records for consultants are required in the same way personnel qualification records are, just applied to an external advisor rather than an employee.
- This provision is frequently relevant when a consultant's recommendation forms part of the justification for a significant quality decision, such as a root cause conclusion or a validation approach.
What FDA inspectors look for
- Whether documented qualification records exist for consultants whose advice informed significant quality decisions.
- Whether the site's own quality unit exercised independent judgment on consultant recommendations, rather than adopting them without internal review.
- Whether consultant-authored documents, such as investigation reports, went through the same internal approval process as internally authored equivalents.
Most common violation
Significant quality decisions, such as a root cause investigation or validation strategy, based substantially on a consultant's recommendation with no documented internal review or independent quality unit judgment applied to that recommendation.
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