Guidelines on the principles and content to be included in preparing a Validaiton Master Plan
1.0 Principle
Validation requires careful preparation & planning of different steps that need to be carried out during the process. Additionally the process needs to be done in a structured way in accordance with the authorized standardized administrative & working procedures
1.1 Characteristics of Validation plan
a) Approach
A valid plan should be made by taking experts advice from various departments like technologists, chemical analysts, engineers, pharmacists, meteorologists and microbiologists on QA\ validation
b) Time
Validation work is to be submitted in rigorous time schedules. These studies help in applying new process and facilities into routine operation
c) Costs
Validation studies involve huge expenditure as they require specialized technology & personnel
The above factors require a structured plan which is to be adequately described in the validation plan
1.2 Purpose
Validation master plan should give an overview of entire process of validation, organizational structure, planning & content. The main aim of VMP must be listing the items that need to be validated and planning schedule
A Validation master plan should
1.3 Definition
A VMP is a document which summarizes firm’s philosophy, approach & intention in order to establish performance adequacy
1.4 Scope
All the crucial validation activities related to processes and products should be included in VMP along with control equipment & critical manufacturing
It should include all concurrent, prospective, retrospective validation and re validation activities
If large projects are undertaken then a separate VMP should be created and the best approach is to include VMP as a part of total project management
2.0 Format & Content
The VMP document should include summary document in a brief and concise manner.
The information should be free from copyright issues and it may refer to the documents like policy documents, validation reports SOPs. The VMP should be accepted by the management
Data on proposed chapters should be included in VMP
Validation policy, description of the operations and its location & schedule should be included in the VMP
2.1 Organizational structure of validation activities:
Personnel responsible for the VMP, Validation work, document preparation & control, training with respect to validation needs, system for tracking the reference & reviewing, approval & authorization should be assigned with a proper organizational flow.
2.2 Description of Product or Process or Plant
They provide a cross reference to the document along with the rational either to include or exclude the validation process for the validation approach and additionally providing the extent of validation
2.3 Process considerations
Extra attention and supervision is needed for few products or processes which may yield a quality product.
2.4 List of products or Processes or systems
The validation activities should be in a matrix format in VMP with including the following
All the items that need to be validated along with the extent of validation whether it is IQ or OQ or PQ
Revalidation activities
Present status and planning for the future
Validation approach
2.5 Key acceptance criteria
For the list of products that are described above key acceptance criteria should be established
2.6 Documentation
The format for reports and protocols should be referred or described
2.7 SOP’s
All the relevant standard operating procedures should be elucidated
2.8 Planning
All the needs during training or staffing should be estimated and in accordance with it the vacancies should be filled. Project should be detailed with proper timeframe. Even the subprojects should be detailed and included in the matrix
The validation master plan should be regularly updated
2.9 Change control
Statement should be made when any critical changes are made to facilities, equipment’s, processes, analytical techniques and materials
Vmp, validation master plan, key acceptance criteria
