Validation plan vs. Validation protocol


I would be very grateful if someone could explain to me what is the difference between validation plan and validation protocol.


A validation plan (VMP) outlines the scope of the work to be done, responsibilities, the approach to be taken etc. It may relate to a new product or a new system or the qualification of your computer network.

The validation protocols are the documents with tests and instructions that are executed for a process, equipment validation or analytical method validation etc. These are cited by the VMP as being required.

A VMP is not always required and is dependant upon the size of the project, whereas you will nearly always have validation protocols in some way shape or form.

Hope this helps

In Validation Master Plan describe the Plan for Validation like which equipment will go for validation & in Validation protocol we describe how to carried out Validation. We write a brief procedure with acceptance criteria in validation protocol.

Validation Master Plan cover following points:

  1. Facility
  2. Authorized person of Plant
  3. Validation Team
  4. Impact Assessment
  5. list of System/Equipment to be validation
  6. Risk assessment of equipment/System departmentwise
  7. format for DQ, IQ, OQ.& PQ
  8. Content of Validation protocol & Validation report.

Mahak Singh
Executive: QA Validation
Promed Exports Pvt. Ltd.
Nalagarh (H.P.)


Validation Plan v’s Validation Protocol

Validation plans seem to slightly vary in content from one company to the next. I am working on a new product at the moment we have a Master Validation Plan which briefly gives a summary of each section of the process and for each piece of equipment we have a Validation Plan which contains the following information

2.Overview of equipment and process
3.References i.e. GAMP. internal SOP’s and teh Master Validation Plan
5.Organizational Structure i.e. System Owner, Technical rep.,QA their role and responsibilities are listed here.
6.GxP assessment, to include info on the vendor audit, risk assessments and regulatory impact and risk critically assessments
7.Validation strategy, v-model. All of the required documentation is listed
and described under the following headings: Step number, Task,Description, Document ref no., Responsibiliyt, Status/ Timeline
8.List of Validation deleverables
9. Acceptance criteria
10.Change control (if your company follows this policy)
11. SOP’s (should list sections that need to be included) by the vendor etc
13. Document Management, who is responsible etc

Validation protocols contains the following information;
1.1 Purpose
1.2 Scope
1.4 Reference Documents
4.1 Methodology
4.2 Installation Qualification Verifications
6.0 Addendum Page


Thanks Ruth

Very comprehensive listing


Dear Ruth
Validation protocol and its component u r talking abt is more relevent to Qualification protocols which not only cover IQ but also OQ and PQ. Anyway as per WHO TRS 937
validation protocol (or plan) (VP)
"A document describing the activities to be performed in a validation, including
the acceptance criteria for the approval of a manufacturing process — or a part thereof — for routine use."
Qualification is a Part of Validation
Relationship between validation and qualification
Validation and qualification are essentially components of the same concept. The term qualifi cation is normally used for equipment, utilities and systems, and validation for processes. In this sense, qualification is part of validation.

All of the responses to the post are very accurate and concise. I would however, also like to add that similar to protocols and subsequent reports the VMPS should have some type of closure. I have seen on many sites that these plans inlcude a scope of work specific to a project and the approaches/strategies may differ based on the project requirements. It is a good idea to list out all deliverables of a particular VMP and close it out with a final report. For ongoing operations this also helps to eliminate the possiblility of one VMP outlieing diffeent strategies than onther one at the same site ( a situation I have seen many get into).


The VMP describes clearly and concisely the company’s philosophy, expectations and approach to be followed. It identifies the systems and controls to be validated and the level of testing required. It covers all aspects of the project as equipment qualification, training, maintenance, and change control. It should be developed in the early stages of a project and allow a logical progression from plan to validation schedule. The VMP can also assist in monitoring and tracking the progress of the project by performing periodic audit reviews v/s the approved version of the VMP. Validation master Plan is complete planning and scheduling of the validation activities to be carried out. it defines outlines the scope of the work to be done, responsibilities, the approach to be taken etc. It may relate to a new product or a new system or the qualification of new area or project.A development of a Validation Master Plan (VMP) early in the validation activities is important to communicate the planned Validation activities to the organisation and validation activities scheduling.

Validation protocol is just the set of procedure or instruction to execute the validation of a particular equipment, system, process e.t.c.

To my understanding, in brief, validation plan describes what to do and when to do and who will do, while validation protocal describes how to do.