Never Replace Approved SOPs with Verbal Instructions in GMP

Follow Approved SOPs—Never Use Verbal Instructions in GMP

Remember: Verbal instructions must not replace approved SOPs in any GMP-regulated activity.

Why This Matters in GMP

Standard Operating Procedures (SOPs) are the backbone of GMP compliance. They ensure consistency, reproducibility, and control across all operations. When personnel rely on verbal instructions, there’s a high risk of misinterpretation, deviation, or undocumented changes. This undermines traceability and creates variability in product quality. Verbal instructions often lack approval, version control, and review, making them unreliable. In critical manufacturing or testing operations, any deviation from the written process could result in contamination, OOS results, or batch rejection. Regulatory agencies expect every GMP activity to follow a documented, approved procedure. Using verbal shortcuts signals a weak quality culture and poor training compliance.

Also Read: The Benefits of EMA GMP Certification for International Pharma Operations

Regulatory and Compliance Implications

FDA 21 CFR Part 211.100 and 211.22 mandate that written procedures must be followed and deviations documented and justified. EU GMP and WHO GMP explicitly state that all instructions must be documented and controlled. Schedule M prohibits undocumented practices and requires SOP adherence for all GMP operations. Reliance on verbal guidance has led to 483s and warning letters citing “failure to follow written procedures.” Auditors review training logs, SOP revisions, and deviation reports to assess adherence. Noncompliance can trigger investigations and affect product disposition decisions.

Implementation Best Practices

Train all staff to refer to current SOPs before starting any GMP activity.
Restrict floor supervisors from giving verbal instructions that conflict with SOPs.
Maintain a controlled master SOP list with distribution records and revision logs.
Document any verbal guidance given as a deviation and investigate its root cause.
Use job aids only as supplements, never as replacements for SOPs.

Also Read: Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas

Regulatory References

FDA 21 CFR Part 211.100 – Written Procedures; Deviations
FDA 21 CFR Part 211.22 – Responsibilities of Quality Control Unit
EU GMP Chapter 4 – Documentation
WHO GMP – Documentation Practices
Schedule M – Standard Operating Procedures and Instructions