What a validation master plan should contain

Annex 15 requires the key elements of the qualification and validation programme to be defined and documented in a validation master plan or equivalent. The VMP is not a protocol; it is the policy and inventory from which protocols follow.

Typical contents

• Validation policy and the quality risk-management approach.
• Organisational structure, roles and responsibilities.
• Summary of facilities, equipment, systems and processes with their validation status.
• Documentation formats: protocol and report templates, acceptance-criteria conventions.
• Change control and deviation management as they apply to validated state.
• Schedule and prioritisation.
• Reference to existing documents and to periodic review and requalification.

A VMP that lists every storage area with its mapping status and next review date is one of the simplest ways to show control of environmental qualification.

What an inspector is reading it for

The VMP is rarely read cover to cover. It is read to answer one question — does this organisation know what it has and how it decides what to do about it? Two sections carry that answer. The inventory says what exists and what state each item is in. The policy says how the extent of qualification is decided. Everything else is context.

Which makes the inventory the part worth the most effort. A table with one row per storage area, its qualification status, the date of the last study, the next review date and the responsible person is the single most useful page in the document, and the fastest way to demonstrate control of environmental qualification.

Note the last two rows. A VMP that lists an area as not qualified and quarantined is stronger evidence of control than one in which every row says qualified, because it shows the inventory is maintained rather than aspirational.

Keeping it a living document

• Tie it to change control, so a new storage area cannot be brought into use without appearing here.
• Review it on a stated cycle and record the review, even where nothing changed — an unreviewed VMP is quickly contradicted by the site.
• Keep the schedule realistic. A plan committing to eleven studies in a quarter that the site cannot resource is a documented failure waiting to be found.
• Reference rather than duplicate. The VMP points at protocol templates, SOPs and the risk-assessment procedure; copying their content in guarantees the copies diverge.

GDP wholesalers

The term validation master plan comes from GMP and Annex 15, and a GDP wholesale distributor is not obliged to produce a document with that title. The obligation that does apply is to qualify premises and equipment and to demonstrate a systematic approach to it. A documented qualification approach plus a maintained inventory of storage areas and their status serves exactly that purpose, and inspectors will ask for it under whatever name the site has given it.