21 CFR 211.160(a) - Laboratory Controls - General Requirements

What it says

The establishment of any specifications, standards, sampling plans, test procedures or other laboratory control mechanisms must include the required specifications, standards, plans and procedures, with deviations from written specifications documented and justified.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This subsection establishes the overarching structural requirement that laboratory control mechanisms exist and be documented, while 211.160(b) specifically addresses the scientific soundness of those mechanisms, together forming the complete laboratory controls framework.
• Any deviation from a written specification, even one that seems minor or well-justified in the moment, requires documentation and justification under this provision, consistent with the broader GMP principle that undocumented departures from written standards are themselves a finding regardless of the underlying reason.
• This provision's structural framing, requiring specifications and procedures to exist in the first place, is foundational to essentially every other laboratory-related citation in this library, since none of those more specific requirements matter if no documented specification exists to test against.

What FDA inspectors look for

• Whether documented specifications and test procedures genuinely exist for all applicable laboratory control points, not just the most obviously critical ones.
• Whether deviations from written specifications, however seemingly minor, are documented with a clear justification rather than handled informally.
• Whether the overall laboratory controls framework demonstrates internal consistency, connecting specifications, sampling plans and test procedures into one coherent system.

Related regulations