Hi,
I am currently developing a MVP for a small laboratory, which will include validation approach etc etc plus a grid with each piece of equipment in the lab that needs to be validated with sections detailing what documents that need to be generated in order to be validated.
Now each piece of equipment will have it’s own validation plan, question I have is do I need to place in here all the documents that need to be generated in order for the equipment to be validated. Hence I will have all this documentation information in the MVP and the VP for the equipment.
Is this normal protocol?
Regards
Hi,
Yes for the MVP you should list all the documents required to be generated, in the VP you further explain what is in the documents and usually dates that they are required by.
Ruth
Hi,
I have seen MVP’s where all possible documents that can be used are stated, and then usually in the VP’s for specific projects the actual documents that will be generated are stated.
It’s all a matter of preference really different companies different policies.
As long as everthing is justified in the VP’s then there should be no issue
Dear Maryacton
As per WHO TRS 937 eng 2006,
validation master plan (VMP)
“VMP is a high-level document which establishes an umbrella validation plan
for the entire project, and is used as guidance by the project team for resource and technical planning (also referred to as master qualifi cation plan)”.
and as per PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
“A Validation Master Plan is a document that summarises the firm’s overall
philosophy, intentions and approach to be used for establishing performance
adequacy.”
So now its clear that a VMP is a master document which represents the entire project, Organization Structure Of All Validation Activities, Facility Description Summary, Utilities And HVAC Description Summary, Validation Program Overview, Change Control Program Description, Key SOP’s and Valdation schedule. Validation schedule covers AMV, Cleaning Val, Area Val, Mfg Equipment Qualification, Lab equipment Qualification and Process Validation. Any way you seem to have VMP for a small lab so i think u should consider the Lab area space for equipment placement, utilities, Testing area categorize for wet chemistry and instrument room, Lab Safety, Personnel safety, All lab equipment Qualification schedule, Calibration and maintenance shedule. Key Sops (ref) for all equipment operation, cleaning, maintenance and calibration. Qualification protocols are to be generated individually for all equipments and reports to be attached later after execution of all activities.
Regards,
Shahid Ali
Addis Pharmaceutical Factory Sc, Ethiopia
Mr. Shahid is right, but i wanna add up some more things in it that in VMP there must suitable to include validation master schedule (VMS), which deals the future intentions and project time lines regarding overall yearly validation activities. Planning the validation activities in diferent quarters.
Dear Maryacton,
Your Question:
Do I need to place in here all the documents that need to be generated in order for the equipment to be validated. Hence I will have all this documentation information in the MVP and the VP for the equipment.
Is this normal protocol?
Answer:
The entire approach, strategy & policy of validation, etc. will be the part of MVP / VMP. (as per the info given by Shahid Ali)
As per the words of Shahnawaz, MVP / VMP should have the Validation Master Schedule (VMS), which deals the future intentions and project time lines regarding overall yearly validation activities. Planning the validation activities in diferent quarters.
Though, all the above-mentioned info is defined in MVP / VMP, you have to have all the docs in place, before going for validation of a particular equipment. It is must.
The protocol for any equipment shall be prepared according to the approach defined in MVP / VMP.
Regards,
Sudarshan