Validation master plan, VMP contents , how to prepared vmp, why VMP , who perform vmp ,organization chat ,documentation involed , factor considering in vmp, cleaning validation , etc

1. 1
Validation Master Plan (VMP)
Presented By:
Assistant Professor
Miss.Priyanka Kandhare
Dept:-Pharmaceutical Quality Assurance
AISSMSCOLLEGEOF PHARMACY

2. INTRODUCTION
2
Defination:
A validation Master Plan (VMP) is a comprehensive document
describing the applicable validation requirements for the
facility, and providing a plan for the meeting those
requirements
• It is a documented programme, which provides a high degree
of assurance that a specific process will consistently produces,
a product meeting its pre-determined specifications and quality
attributes.
• The VMP should be a summary document, which is brief,
concise and clear.

3. Validation Master Plan
3
Computer
Qualification
SOP’s OQ
DQ
IQ
Calibration
SOP’s
Records
PQ
Cleaning
Qualification
Preventative
maintenance
plan
Personnel
-Training
- Experience
Change
Control
-Project
-ProcessIdentify items
to be qualified
Approved design
documentation List system
to be
qualified
Identify items to be
calibrated for GMP
and safety
Identify
systems and
subsystems
Identify systems
to be qualified
(includes dust
control)

4. Why to perform VMP?
4
 VMP is not a requirement of the FDA, but it has become almost
an industry standard.
 It is important to include such a document, as it sets the overall
goals and limits that will be followed during validation, and can be
referred to throughout the project.
 As a reference document, the plan permits the reviewer
immediately to understand the scope of the validation and so avoid
misconceptions.

5. Who performs VMP?
5
Members:
 Validation manager, Quality Assurance department.
 Member from production
 Member Engineering (utilities)
 Member from Calibration lab
 Member from QC lab
 Member from Maintenance
 Member from HVAC department.
 Member from Product development lab

6. Who performs VMP?
6
Organization chart
Validation team
(review-team)
Validation
representative
Qualification
team
Process
Validation
team
Cleaning
Validation
team
Computer
Validation
team
External
Validation
service

7. Which Factors are considered in VMP?
7
Contents of VMP:
•Introduction
•Methodology
•Qualification
DQ
IQ
OQ
PQ
•Personnel
•Schedule
•Preventative maintenance
•Change control
•Procedure
•Documentation
•Appendices

8. VMP Contents
8
Introduction:
 This section is written as an introduction to the validation process
and the facility, and it is intended to set the scene.
 The introduction of a VMP should include following details:
 a description of facility, its premises and equipment, and its
purpose.
 intension and scope of validation.
 - other relevant site policies and plans, like factory or corporate
policy statements on GMP, QA, etc,.

9. VMP Contents .)
9
Methodology :
 This section should address the predetermined requirements by
identifying the standards that are to be applied to the facility.
 These are then used in the development of the acceptance criteria
that are used to judge the validation.
 The standards will involve three elements:
• Regulatory and guidance documents
• National standards
• Company standards

10. VMP Contents )
10
Qualification:
 This section include all aspects of the design, procurement,
installation, and commissioning process.
 It cover all aspects of the validation process, and that the
validation structure and organization is clear to any inspection
authority.

11. VMP Contents
11
Personnel
The CFR 21 states “ Each person engaged in and each person responsible for
supervising the manufacture, processing, packaging or holding a drug
product shall have the education, training, and experience, or a combination
there of, to enable that person to perform the assigned functions.”

12. VMP Contents )
12
Schedule
The work program is essential and should be prepared at an early
stage. A good plan will contain all the necessary features which are to
be considered during execution of a plan and determines the control
of the project.
Preventative maintenance
-This is the responsibility of Site maintenance and Operation
department.
-This activity should be performed during the design phase, and the
documentation required should be, included in the requisition.

13. VMP Contents
13
Change Control
This section of VMP should lay down requirements for a set of
procedures for change control that cover:
- The project through design, construction, and commissioning
- The ongoing change that will inevitably occur in both the process
and the equipment and engineering aspects.
Procedures
These cover engineering standards used in the project design, through
to commissioning phases, and the facilities standard procedures
(SOPs).

14. VMP Contents
14
Documentation
This section usually used to identify the documentation that should be
produced for the processing like;
•Engineering drawing
•Equipment supplier drawing and documents
•Factory acceptance documents
•IQ documents
•OQ documents
•PQ documents
Appendices
The appendix is mostly used VMP to hold the information of type of
documents and formats that will be used in the execution stage.

15. How VMP is prepared?
15
Installation Qualification: IQ
It is performed to verify that the installed components are the ones
specified, that they are properly identified, and so on, as stated in the
construction documents in accordance with the specific requirements
of the user.
IQ protocol includes:
•Verification of procedure (e.g., operation, maintenance, cleaning,
change control)
•Verification of major components
•Verification of control and monitoring devices
•Verification of utilities connections
•Lubricants
•Final drawing, Reference manuals

16. How VMP is prepared?
16
Operational Qualification: OQ
This involves the testing of various components of the system,
process, or equipment to document proper performance of these
components.
OQ protocol includes:
•Verification of test equipment calibration
•Verification of controls and indicators
•Computer control system testing
•Verification of sequence of operations
•Verification of major components of operation
•Verification of alarms
•Power failure/recovery testing

17. How VMP is prepared?
17
Performance Qualification: PQ
•This involves challenging the system, process, or equipment to
provide evidence of appropriate and viable operation.
PQ protocol includes:
-System sampling
-Equipment cold-start tests
Operating Procedure:
• Procedures must be prepared for all operations to be performed
during the execution of a protocol called as Validation operating
procedures, SOP’s, operating manuals.
• It ensure that the system, process, or equipment is operated
consistently during validation and exactly as it should during normal
operating conditions.

18. How VMP is prepared?
18
Change control procedure:
 This procedure is essential for the continuous operation of the system
,process, or equipment and provides a formal mechanism for
monitoring changes during the continued operation of the system.
 The proposed changes that can affect the validated status of a system
are reviewed by the validation team or responsible personnel and the
proposed corrective action is approved.
 Sufficient detailed documentation is necessary for each critical change
to maintain control over the system with the passage of time.

19. Cleaning validation
19
 Cleaning validation (CLV) is a written evidence that determines the a
specified cleaning procedure will lead to reliable and repeatable results
in the cleaning of surfaces with and without contact with the product.
It is shown that the following criteria are fulfilled:
 The concentration of active substances on product contact surfaces will
not exceed specified limits.
 The concentration of highly active substances on surfaces without
contact with the product will not exceed specified limits.
 The concentration of other pharmacologically active substances in the
product to follow will not exceed specified limits

20. References
20
 Potdar M.A ,Pharmaceutical Quality Assurance, Third
Edition, Nirali Prakashan,2013.page no:8.42-8.43.

21. Thank you...!!
21