Glossary
Written Procedures
Instructions written in advance for how production and process control are to be carried out, approved by the appropriate organisational unit and by the quality control unit.
Details
This is the phrase that appears most often in United States findings, cited in two forms: the procedure was never established, and the procedure existed but was not followed. Real cases include no cleaning or equipment maintenance procedure, revisions that did not go through approval by the appropriate unit and the quality control unit, and records written up later in a batch rather than at the time of performance. Because 211.100(b) requires any deviation from the procedure to be recorded and justified, check the approval block and the copy available at the point of work together with the justification records for departures from it.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to follow written procedures regarding storage and warehousing of drug products (21 CFR 211.142).
FDA · FDA Warning Letter · 2021-11-09 -
Your firm also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.
FDA · FDA Warning Letter · 2024-08-27 -
Your firm also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile and that include validation of all aseptic and sterilization…
FDA · FDA Warning Letter · 2026-07-14
