20.07.2017

Validation Master Plan

Validation Master Plan

A validation master plan (VMP) is a document that summarizes the company's overall philosophy, intentions, and approach towards performing validation.  

“All validation activities should be planned. The key elements of the validation program should be clearly defined and documented in a validation master plan or equivalent documents. 

The validation master plan should be a summary document and should therefore be brief, concise, and clear.  

The validation master plan should contain the following information: 

а) validation policy; 

b) organizational structure of validation activities; 

c) summary of facilities, systems, equipment, and processes to be validated; 

d) documentation format: the format to be used for protocols and reports; 

e) planning and scheduling; 

f) change control; 

g) references to existing documents. 

In the case of large projects, it may be necessary to create separate validation master plans”. 

EU GMP Annex 15: Qualification and Validation. 

Validation master plan 

Recommendations for development documents such as VMP first appeared in PIC/S (Pharmaceutical Inspection Cooperation Scheme) Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation (РI 006). 

EU GMP Annex 15: Qualification and Validation was published in 2001This Annex describes the main principles of qualification and validation. Decisions on the scope and extent of qualification and validation should be based on risk assessment. Every action should be planned, meaning its clear definition and documentation in a validation master plan (VMP) or equivalent documents. 

Our company Validation Center provides services on developing validation master plans, which structure complies with the requirements of PIC/S Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation (РI 006), and EU GMP Annex 15: Qualification and Validation. 

Our company Validation Center provides services on developing validation master plans, which structure complies with the requirements of PIC/S Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation (РI 006), and EU GMP Annex 15: Qualification and Validation.