Free practical tool · Version 1.0

GMP Self-Inspection Starter Checklist

Use objective evidence—not impression—to identify the first system priorities.

Site/area: __________________________________

Reviewer: __________________________________

Date: ______________________________________

For each statement, mark Yes, Partial, No or Not Applicable. Record the evidence reviewed and the action needed. This starter tool is not a substitute for a risk-based self-inspection programme.

Need the complete process? Read the practical GMP self-inspection guide.

01

Procedures at the point of work

Current approved instructions are available where the activity is performed.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Obsolete or uncontrolled copies are prevented from use.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

The instruction matches the actual process, equipment and responsibilities.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

02

Training and competence

Personnel are trained before independently performing assigned GMP tasks.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Effectiveness is assessed through observation, questioning, demonstration or performance evidence.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Retraining needs are linked to changes, deviations, trends and periodic review.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

03

Deviation investigation

Events are reported promptly and immediate containment is documented.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

The investigation considers process, material, equipment, method, environment and human factors.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

The conclusion is supported by evidence and addresses recurrence or related-system risk.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

04

CAPA effectiveness

Actions address the verified or most probable cause, with owners and due dates.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Implementation evidence is retained and overdue actions are escalated.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Effectiveness criteria, timing and evidence are defined before the check is performed.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

05

Data and records

Entries are attributable, legible, contemporaneous, original or true copies, and accurate.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Corrections preserve the original entry and include an appropriate reason when required.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Reviewers assess content and process evidence—not only signatures and completion.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

06

Change control

Changes are described, justified and risk-assessed before implementation.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Impacts on validation, regulatory commitments, documents, training and supply are evaluated.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

Post-implementation checks confirm the intended outcome without adverse consequences.

Yes □Partial □No □N/A □

Evidence / action: ________________________________________________

First three priorities

1. ________________________________________________________________________

2. ________________________________________________________________________

3. ________________________________________________________________________

Prepared by Pharma Ops Academy · Version 1.0 · 21 September 2026 · Review before use within your approved quality system.