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VMP Gap Assessment

PIC/S PI 006-4 validation master plan topics, scored in the browser.

Based on:PIC/S PI 006-4

Rules version 1.85 · Last checked 2026-11-06

PIC/S PI 006-4 entered into force on 1 October 2026. Section 3.4.3 states: “A VMP should contain information on the following topics:” covering (a) through (m). This checklist is a planning aid, not a substitute for a site validation master plan.

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PI 006-4 §3.4.3 (a)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

The manufacturer’s validation approach, general description of the scope of operations covered by the VMP, location and schedule (including priorities).

Quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

PI 006-4 §3.4.3 (b)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Name who is responsible for the VMP; for protocols of individual validation projects; for doing the qualification and validation work; for preparing and controlling reports and documents; for approving and authorising protocols and reports at each stage; for the system that tracks those documents; and for training needs that support qualification and validation.

Paraphrase of PIC/S PI 006-4 §3.4.3 (b) (1 October 2026). Not a quotation.

PI 006-4 §3.4.3 (c)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Explain the reason for a challenge or a worst-case condition. Consider grouping products or processes so a worst case can be validated. Where that situation cannot be simulated, define why the grouping was chosen. Base these choices on quality risk management. A worst case is used so the process is robust across expected variation. It is not a test aimed at the point of failure.

Paraphrase of PIC/S PI 006-4 §3.4.3 (c) (1 October 2026). Not a quotation.

PI 006-4 §3.4.3 (d)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Point to other documents instead of repeating them. Include why qualification or validation is included or left out, which validation approach the site uses, and how far that validation extends.

Paraphrase of PIC/S PI 006-4 §3.4.3 (d) (1 October 2026). Not a quotation.

PI 006-4 §3.4.3 (e)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Includes specific characteristics or requirements of the plant, process, etc. that are critical for yielding a quality product and need extra attention.

Quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

PI 006-4 §3.4.3 (f)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Summarise every qualification and validation activity. Include each facility, supporting utility, equipment, system, and process that is in scope, and describe how much qualification or validation it needs. State whether validation is prospective or concurrent, and list the products if concurrent validation is used. Justify the re-qualification frequency and describe the system for ongoing process verification. Record the current status and future plans.

Paraphrase of PIC/S PI 006-4 §3.4.3 (f) (1 October 2026). Not a quotation.

PI 006-4 §3.4.3 (g)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

The template document format to be used for any qualification and validation protocols and reports should be defined.

Quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

PI 006-4 §3.4.3 (h)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

A list of all relevant SOPs for qualification and validation should be included.

Quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

PI 006-4 §3.4.3 (i)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Guidance should be given on developing acceptance criteria.

Quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

PI 006-4 §3.4.3 (j)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Consider staffing, including training, ancillary testing equipment, and other specific needs while planning. Those items do not all have to be written into the VMP. The VMP should define how often it is updated.

Paraphrase of PIC/S PI 006-4 §3.4.3 (j) (1 October 2026). Not a quotation.

PI 006-4 §3.4.3 (k)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

A statement of the manufacturer’s commitment to controlling changes to facilities, supporting utilities, equipment, processes, and systems which may directly or indirectly affect the quality of the medicinal product.

Quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

PI 006-4 §3.4.3 (l)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Describe how deviations during qualification and validation are handled. Besides a protocol that was not run as written, a deviation also includes a result that misses the acceptance criteria defined beforehand. Discuss what the deviation means for the qualification or validation in the report. Also make the deviation visible in the manufacturer deviation system, so later investigations during routine production can find it.

Paraphrase of PIC/S PI 006-4 §3.4.3 (l) (1 October 2026). Not a quotation.

PI 006-4 §3.4.3 (m)

Topic label quoted from PIC/S PI 006-4 §3.4.3 (1 October 2026).

Define what is required to confirm data integrity in qualification and validation reports. Someone who is not performing that qualification or validation work should complete the confirmation. Whether it is done as a formal protocol depends on the nature of the work.

Paraphrase of PIC/S PI 006-4 §3.4.3 (m) (1 October 2026). Not a quotation.

Planning aid only. Not a certified audit, not a site validation master plan, and not legal or regulatory advice. Confirm the current PIC/S PI 006-4 text. Runs in your browser. Invented example data only. Nothing is uploaded.

VMP GAP

Set Present, Partial, Missing, or N/A on the PI 006-4 VMP topics to see the gap score.

% complete = Present ÷ (Present + Partial + Missing) × 100

N/A and blank rows are excluded. Partial is a gap.

Calculation values stay on this device.

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CH 25 · notes

How it works

PIC/S PI 006-4, Recommendations on Qualification and Validation, entered into force on 1 October 2026. Section 3.4.3 says a validation master plan should contain information on topics (a) through (m). This page scores those thirteen topics and no others. Each topic label is quoted from that section. Quoted supporting sentences: 6. Paraphrased supporting sentences: 7. A paraphrase is marked on the row. It is not a quotation.

Section 3.1.1, paraphrased, says the plan should be risk-based and scientifically sound, and that it sets the manufacturer’s overall approach to qualification and validation. Section 3.4.1, paraphrased, says the VMP is a short summary: it should not repeat other documents, and it should include at least the information in §3.4.3 or point to policy documents, SOPs, protocols, and reports. Section 3.4.2, paraphrased, says management approves the VMP, and that it is reviewed and updated when facilities, supporting utilities, equipment, systems, or processes change. Those three sentences are context. They are not extra scored rows.

Percent complete is Present divided by Present + Partial + Missing, times 100, half-up to one decimal. N/A and blank rows are excluded. Partial is a gap and does not count as complete. The score is a planning tally. It is not an audit rating.

Planning aid only. Not a certified audit, not a site validation master plan, and not legal or regulatory advice. Confirm the current PIC/S PI 006-4 text.

Last checked 2026-11-06.

Worked example

Invented title VMP-DEMO-001. Eight topics are Present, two are Partial (organisational structure, and planning and scheduling), two are Missing (required SOPs, and deviation management), and specific process considerations is N/A. Applicable count is 12. Percent complete is 66.7 %. The N/A row is not in that denominator. Load example fills the same invented notes. Clear returns every row to Not assessed.

Related tools

Topic (l) is deviation management. Draft an investigation structure on the CAPA & 483 Response page. The CCS Gap Assessment page scores EU GMP Annex 1 contamination-control elements. The MACO / HBEL page calculates a cleaning limit from a PDE. This checklist does not score those other documents.

Sources

FAQ

How is the VMP gap score calculated?

Percent complete is the count of Present divided by Present + Partial + Missing, then multiplied by 100 and rounded half-up to one decimal. N/A and blank rows are left out of that denominator. Partial is a gap. It does not count as complete. The thirteen topic labels are quoted from PIC/S PI 006-4 §3.4.3 (a)–(m), in force 1 October 2026. Short supporting sentences are quoted. Longer paragraphs are marked paraphrases. No topic is added beyond (a) through (m).

What should a validation master plan contain under PI 006-4?

Section 3.4.3 states: “A VMP should contain information on the following topics:” and then lists (a) Introduction through (m) Data Integrity. Section 3.4.1, paraphrased, says the VMP is a short summary and may point to other documents instead of repeating them. Section 3.4.2, paraphrased, says management approves it and that it is updated when facilities, supporting utilities, equipment, systems, or processes change.

Does Partial count as complete?

No. Partial stays in the denominator and is counted as a gap, together with Missing. Only Present counts toward the percent. N/A and rows left as Not assessed are excluded.

Is this checklist a site validation master plan?

No. It is a planning tally against the thirteen §3.4.3 topics. It is not a certified audit, not a controlled VMP, and not legal or regulatory advice. Confirm the current PIC/S PI 006-4 text.

Does this page upload my gap notes?

No. The score and the DOCX or XLSX export stay in the browser. Planning aid only. Not a certified audit, not a site validation master plan, and not legal or regulatory advice. Confirm the current PIC/S PI 006-4 text.