Glossary

Standard Operating Procedure (SOP)

A document setting out the approved method and sequence for performing a particular operation consistently.

Related sections

EU GMP Part I Chapter 4 21 CFR 211.180–211.194

Findings from regulators' inspection documents in which this term appears.

For example, since September 27, 2022, nine of (b)(4) employees approved as physician substitutes by your Medical Director failed to complete the (b)(4) (minimum) training program required by your Standard Operating Procedure, 03.05, “Physician Substitute Training Program”(Effective Date: 05-27-20).
FDA · FDA Warning Letter · 2024-10-15
Regarding your firm’s deficiency in monitoring environmental conditions, your SOP CSP-080 Viable and Nonviable Air Sampling states viable air sampling “is conducted continuously during the compounding of CSPs in the ISO 5 environment by compounding personnel”.
FDA · FDA Warning Letter · 2026-05-12
Your firm manufactures over-the-counter (OTC) topical drug products, including hand sanitizers, Tincture Green Soap USP, and Isopropyl Alcohol 70% v/v.
FDA · FDA Warning Letter · 2025-07-22

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

GRM Regulatory Glossary

Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.