21 CFR 211.86: Use of approved components, drug product containers, and closures
Requires manufacturers to rotate approved components, drug product containers, and closures so the oldest approved stock is used first, allowing only temporary, appropriate deviations from this first-in, first-out practice.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart E, Control of Components and Drug Product Containers and Closures
How FDA words it
The opening lines investigators use most when they cite 211.86, from the 483s we hold.
There is a lack of rotation so that the oldest approved stock of components is used first.Most used
Recent 483s citing 211.86
- Form 483 · FEI 3000538793 · Ramos Arizpe, MexicoThe firm’s inventory management process did not prevent the use of newer materials… Sep 23, 2022
- ScinoPharm Taiwan, Ltd. · Tainan, TaiwanThere is a lack of rotation so that the oldest approved stock of components is used… Apr 1, 2022
- Sandoz, Inc. · Broomfield, ColoradoThere is a lack of rotation so that the oldest approved stock of components is used… May 6, 2011
- KV Pharmaceutical · Saint Louis, MissouriThere is a lack of rotation so that the oldest approved stock of components is used… Feb 2, 2009
The regulation text
§ 211.86 Use of approved components, drug product containers, and closures.
Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
Questions
What does 21 CFR 211.86 require?
Requires manufacturers to rotate approved components, drug product containers, and closures so the oldest approved stock is used first, allowing only temporary, appropriate deviations from this first-in, first-out practice.
How do FDA investigators word a 211.86 observation?
The most common opening is: “There is a lack of rotation so that the oldest approved stock of components is used first.”
Which sections are cited alongside 211.86?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance), 211.110 (Sampling and testing of in-process materials and drug products), 211.160 (General requirements).