I’m trying to work out what the difference between these two documents are. My uderstanding is the the VMP is a general all encompassing document that states the companies position on validation and the process for validating whereas the VP is more specific and deals with a specific process/equipment/system/whatever. However the more information I read on this the more they seem to get used interchangably. Are they interchangable? Is my understanding completely wrong and if so what is the difference?
Normally I prefer following approach:
VMP’s are for Departments,
VP’s are for Projects.
I also think that a customized approach can be taken and the regulatory has nothing to it.
I agree with Bartual overall. Our VMP covers our site and gives our overall approach (ie we will validate processes, cleaning, sterilisation, environments, analytical methods etc) and general responsibilities (by function not by role or person’s name).
We then have at least one VP per validation exercise which shows its scope, objectives, resonsible personnel (by role / job title), the planned documentation and activities which will be carried out, which form of risk assessment(s) will be used and when - and gives the detailed approach to that specific project.
Cat
Dear
Absolutly right ,VMP (Validation Master Plan) as you know VMP it is clearly defined by the name of VMP inwhich all the plan of validation activity, calibaration schedule, Preventive maintenance schedule & description of facility are discussed but in the VP (Validation Protocol) we described only about procedure which is follow by us during a validation of process. like sterilization by autoclave, process validation.
Summarize, in VP we disscussed only a single process/procedure but in in VMP we described how to start validation & calbration activity of plan.
A Validation Master Plan (VMP) is a living document that identifies the planned validation activities for an organization. It provides an inventory of the items that are subject to validation, including an assessment as to whether these items require validation based on their GMP impact and criticality. A VMP is typically prepared for a specific year. It provides management the opportunity to adequately plan and resource the validation activities to be performed for the year. The following items should be included in the VMP:
- Processes;
- Products;
- Equipment;
- Computer Systems;
- Legacy Systems;
- Macros and Spreadsheets (used in the design or manufacturing of a product).
For each item in the VMP, the following information must be included as a minimum:
- Identification
- Owner
- Deployment Status
- Number of Years In Use (if applicable)
- GMP impact Yes/No
- Critical Yes/No
- Validation Status
- Validation Summary Report Date (if applicable)
- Validation required Yes/No
- Planned Validation Activities (if applicable)
- Validation Schedule (if applicable)
Many organizations separate the list of items from the VMP and put them into a Validation Master List. That’s fine as long as the VMP refers to this list. The list of items subject to validation is an integral part of the VMP.
Some organizations also include a high level validation strategy for a specific item type into the VMP. This will provide management insight as to what needs to be done to get these items in a validated state.
A Validation Plan (VP) or Verification & Validation Plan (VVP) is a document that defines the verification and validation activities to be performed to get a specific item (identified in the VMP) in a validated state. If not separately provided, it shall also include the Validation Strategy and the process for deviations from the VP.
A Validation Protocol is a generic term for any protocol that defines the process and responsibilities to perform a specific validation activity. E.g. Operational Qualification Protocol.
My apologies if this post is perceived as lecturing.
Cheers!
Aristoteles
The regulators expect to see no more than two VMP documents in place for any one facility. That is there will only be two top level validation plans representing how validation has been integrated into all production activities. These are usually, a standard VMP covering the facility, plus a secondary VMP covering a subject or subjects that may involved differing methodology from the plant in general, such as computers or software, or extensive equipment systems such as Distributive Networks (DCS) or Building Management Systems (BMS).
However when it comes to projects, the situation is rather different. Validation Plans are used to define scope and document validation requirements, and where equipment or systems have similar validation requirements, a single VP will suffice. However where the; what, where, why and who, criteria’s are different, more than one VP is required. When more than one VP is required, then a VMP is required to explain, define and authorize the additional VP’s. It is therefore quite normal to see major refits and modifications being covered by a VMP.
This does not affect the validity of the main plant VMP.
Alex Kennedy
CEO
Dear all,
Can you explain more detail what is project validation plan?
My understanding is there is a templates, list, and other information which described project more detailed.
For example: Project validation plan for validation process, there is a validated product list.
My question:
If the PVP approved on dec 2009, validated product list is all product that validated before dec 2009, is not it?
Is it necessery to list the product which will be validated in 2010?
How often PVP should be revised to update validated product list?
thanks a lot for your explanation
I do agree.VMP should describe Policy of Validation of the concrned topics/items and frequency thereof, while PV should give details of actual validation process.
Regards,
Dr.Barve
It depends very much upon your local strategy/validation lifecycle and organisational structure.
I use the approach of having a Site VMP (sVMP) which details the yearly approach to Validation at a high level (essentially acknowledging the requirements of our regulators, identifying which areas of the business are subject to regulation, and listing the governance processes in place to ensure compliance with that regulation).
Underneath that sVMP hang VMPs. These detail the governance processes required for specific validation activities against a specific project where (generally) a project spans departments or is of a size which is unsuitable to be incorporated into a VP.
VPs hang under VMPs or directly off the sVMP dependent on size of project. If, for example, a project is small and straightforward and doesn’t span departments, a VP can be authored detailing the approach directly in accordance with the sVMP. If a project spans departments e.g. steriles and packaging, a VMP is authored for the project and specific VPs written for the areas as both areas will have different regulatory requirements.
Simple! 
Cheers
Monkey
I agree with Bartual views.
Many studies have examined the effect of testosterone on the embryonic female UGT, and have shown that administration of testosterone leads to prostatic induction in vivo or in vitro (Cunha and Chung, 1981; Jost, 1947; Jost, 1953; Takeda et al., 1986). Androgen signalling via AR in mesenchymal cells is required for prostatic development, but other details of how prostatic induction occurs are not known. Comparison of P0 male and female rat reproductive tracts showed a similarity in the anatomy of the male VP and female VMP. The female VMP induces prostatic development in tissue recombination studies in vivo in response to testosterone (Timms et al., 1995). It is clear that mesenchyme in the VMP has prostatic inductive activity, and that androgens are involved in prostatic induction and growth. What is less clear is how androgens regulate inductive activity of the VMP mesenchyme.
We report that the position of the VMP was coincident with a gap in the SM at the junction of the urethra and bladder. The discontinuity in peri-urethral SM was similar in both males and females from E17 until E19, after which a sexually dimorphic difference was observed. In E20 females, a layer of SM formed between the urethral epithelium and the VMP, whereas in males this SM layer did not become continuous. Ventral prostatic buds that emerged from the male urethra were anatomically positioned in the middle of the SM discontinuity and directly adjacent to the VMP. A model describing the chronology and anatomy of prostatic bud induction is shown in Fig. 8. On the left side is a UGT between E17 and E18.5 showing an ‘open’ SM layer (i.e. a gap between urethral and bladder SM). We propose that the gap in SM allows interaction between the VMP, urethral epithelium and prostatic buds that have emerged from the urethra. The gap in the SM layer may allow inductive signals from the VMP to reach the urethral epithelium and induce budding, or epithelial buds (perhaps made constitutively in males and females) to come into contact with the VMP. Buds of the VP are first observed at E18.5 in the rat (Timms et al., 1994). On the right of Fig. 8 are male and female UGTs at E21.5. Development of the UGT in females (without androgens) leads to thickening of the SM layer and inhibition of prostatic induction, though some budding may have occurred. We propose that separation or isolation of the VMP from the urethral epithelium by SM prevents prostate development in females. In males (with androgens), formation of the SM layer is inhibited or delayed, and prostatic buds emerging from the urethra can penetrate the VMP, which elicits further epithelial growth, mesenchymal/epithelial interactions and branching morphogenesis. This study demonstrates that testosterone can affect the thickness of the peri-urethral SM layer and suggests that inhibition of SM differentiation by androgens enables prostatic induction in males.
Thanx for the information.
Why don’t we think VP is a Validation Protocol which describes about one secific product or process to be carried out validation. Every one know VMP abbreviation but what is the VP abbreviation. Let we know about that please. IN VMP we can describe validation activaties like all i.e Qualifications and Process, analytical. But usually we don’t describe about expected problems in VMP due to it is applicable to all. But VP is limited and concern to only one particular Product or process, activity which is to be validated. It should give more comprehensive details not general like VMP. VMP describe activity as per guidelines but we give the details in VP beyond of Guidelines if possible with scientific judgements.
Thx
Pulla Reddy Karnati
Executive - QA
dear all
as per my concern validation master plan (VMP) is a guide how to approach valiadtion (if any)
and validation shedule is to show the plan for the year
validation protocol (VP) is set of instruction to excute the validation
pls apolgy me
if any wrong
Yep, Quite Interesting !
Validation v/s Verification
Validation v/s Qualification
VMP v/s VP…& lots more isn’t it ? Life becomes tedious at this place.
In fact the terms are having a littile LOS (Line of separation) which some time overlap with each other & started confusing the users. It is absolutely fine from Individuals point of view that these are different terms & should be properly segregated but is it really matters…? What if had putted the corrected terminology but content is inadequate…?
Rather than this I would like to suggest that the approach should be clear. use the block / flow diagrams for explaning the term what means what…? during audits & other stuff we should be very clear about the flow & generation of document as well as the content of that document…
Happy Reading !
Im looking for a sample template of VMP. Can anyone share a sample? Thanks