Anonymous
|
I would be very grateful if someone could explain to me what is the difference between validation plan and validation protocol.
Alan
|
Anonymous
|
In response to Anonymous
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
Regards
PaulS
|
ValidationSystem
stranger
Posts: 17
|
In response to Anonymous
I pretty much agree. The VMP pretty much summarizes your approach toward validation. It may include systems, equipment, processes, methods, etc... Typically? it will document the "how" relative to validating your system. It will not have many of the technical and grunt level details that are embedded in your validation protocol. Instead it may address what type of testing you will do for each type of system (ie IQ, OQ, PQ,), how you will address reval/change control, how you will address routine monitoring (ie for HVAC/clean room), etc... The VMP may also answer "why" regarding your approach (ie why do you test for 1, 2, 24, or 72 hours...) Think of the VMP as the summary guidance document harmonizing? all the various validations you have under your roof.
The validation protocol will be specific to the validation of a particular item. It will have the basic make, model, function, operation, etc...
|
P Smith
Beginner
Posts: 1
|
In response to
Do you happen to know where I could go to acquire some help in a validation project that I am doing?
|
PaulS
Member
Posts: 177
|
In response to P Smith
What are you validating? is it existing or prospective?
PaulS
|
Johan
Beginner
Posts: 5
|
In response to
Hi Alan,
A good help can be given by the ISPE baseguideline volume 5 commissioning and qualification. this will give you all definition and a view on how to validate/qualify things.
A really brief synopsis of the work can be found here.
http://www.ispe.org/galleries/publications-files/C...
I have to feeling you never qualified something before. There are a lot of engineering companies (pharmaceuticals) that can provide qualification/validation assistance.
Johan Janssens
The Jolly Qualification Engineer
Main Base: Jacobs Office Antwerp
Mobile: +32 498 68 29 56
e-mail: johan.janssens@jacobs.com
|
Edited by Johan on 11-07-06 02:53 AM. Reason for edit: No reason given.
|
maragoni ramu
Beginner
Posts: 2
|
In response to
Validation master Plan is complete planning and scheduling of the validation activities to be carried out.
who is reponsible for the execution
What activities to be tested
how to produce the report
Validation protocol is just the set of procedure or instruction to execute the validation of a particuler equipment
|
07-20-05 07:22 PM -