3. Introduction
The design, construction, and commissioning of a new facility
for the pharmaceutical industry is a complex.
The approach that can be used by the designer to ensure that the
design, engineering and construction process can meet the
GMP requirements are completely based on the plan of a
validation strategy.
4. Definition:-
Validation master plan is an internallly approved
document that describes in clear and concise wording
the general expection method and approach to be used
during the entire validation effort.
Scope:-
VMP includes all relevant aspects to the Production of
pharmaceuticals in the production facility.
The principle of validation, the organization of
qualification and equipment are also described.
It covers all facilities used in variation production areas,
storage, services and the rooms for staff.
5. General Requirement
Validation Master Plan may be defined as an internally
approved document that describes in clear, unequivocal
and concise wording, the general expectations,
intentions, methods and approach to be used during the
entire validation effort.
The FDA inspectors during their audit ask for VMP as a
source document along with other important source
documents like:- site Master File or Calibration Master
Plan etc. Hence, this document must always be updated
and in the presentable form.
The size of the master plan cannot be defined, but it
should not be just 4 or 5 pages, at the same time it
should not be as bulky as 400/ 500 pages also. Only acid
test for this is it must explain precisely and concisely
time table and persons responsible for carrying out
various activities. Normally a V.M.P. runs to about 40-
50 pages.
6. The main advantages of the VMP is for the validation
people of the organization and the FDA and other auditors
and inspectors.
Validation master plan must start as early as possible of in
case of new pharmaceutical plants.
For new facilities it should be ready even before the
building plans are ready. In short U.R.S. and D.Q. should
be the beginning of the facility validation. Similarly before
selecting the equipment the D.Q. of the proposed
equipment should be ready and then it should follow the
I.Q., O.Q. and P.Q. Etc.
7. User Requirement Specification
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Step of validation
Change Control
8. Validation master plan
DQ
• Approved
documentation and
spacs.
IQ
• List system to be
qualified
OQ
• Identify
systems
and
subsystems
Calibration
• Identify
iteam to be
calibrated
for GMP
and safety.
• SOP’S /
Records
Cleaning
qualification
• Identify
systems to
be qualified
10. Specific Requirements
1) Approval page and table of content:
Normally this document should be prepared by
one person, checked by another person and
approved and authorized by the head of QA or
location head, as per the policy of the company.
The contents can ideally be in the following
sequence:-
a) Approval page
b) Table of contents
c) Introduction of objectives
d) Plant and process description
11. e) Personnel Planning and Scheduling
f) Responsibilities of committee members
g) Process control aspects
h) Equipment and apparatus, instruments to be
qualified
i) Process and systems to be validated
j) Acceptance criteria
k) Documentation required including reference to
validation protocols
l) SOP,s
m)Training requirements
12. 2) Introduction and objectives:
In this section you should introduction the
objectives of the documents.
Te objectives may be something like this.
- to vaidate all facilities, equipment and
processes in this plan.
13. 3) Plant and process description:
A brief outline of the plant like where the plant
is situated age of the plant, technology used in
the plant e.g. you can mention we have fluid
bed processing technology in tableting high
output equipment in injectables RO. and EDI
system in water treatment plants. The idea here
is to give a feel for volumes of production
handled, caliber of people, you have advanced
analytical instruments in your Q.C lab etc.
14. 4) Personnel, planning and scheduling:-
In short describe in brief the team members of
validation team with their names, educational
qualification, experience they have in their field
and in the validation activities in this company as
well as in their earlier employment.
This is actually to provide the auditor the
confidence in the work of validation that this
company is doing.
15. Planning :- descibe complet scop of your
planned activies here, preferably in a proper
logical sequence like...
a. Facility validation
b. Equipment validation
c. Utilities validation like HVAC, water, electric
power etc.
Scheduling:- time table to activity will start and
when it will get over.
So normally all the activity are fist listed
vertically on the left side giving serial numbers
and right side provide three columns..
-date of start, date of completion, remarks
Date may be replaced by week the month and the
year.
16. 5) Responsibilities of committee members:
Responsibilities of all the team member, e.g
responsibility of head of validation team can be
stated like this:
-to select and train team members
- to execute plans timely and satisfactorily.
6) Process control aspects:
You have to identify all the controls you are
going to monitor during the process validation
and other activities. e. g. In sterilization process
you have to identity that tou are going to
maintain temp. and pressure.
17. 7) Processes and System to be validated:
Here also you have to make a list of processes and
systems which you plan to validate, e.g.
a) List of processes to be validated can run something
like this:
Shifting Mixing
Milling Autoclaving
Filling
Tab compression
b) List of system to be validated can run some thing
like this:
HVAC
Purified Water Water for injection
Granulation of tablets etc.
18. 8)Acceptance Criteria:
Here define the parameters in each validation
activity and the limits of acceptance, e.g. in case
of mixing of dry powers the assay of the active
substance should be within 99 to 101% etc..
10)Documentation:
List all documents related to validation activities,
e.g. various protocols and reports that you are
going to generate, SOPs. training manuals and all
deliverables from the validation department..
It is advisable to specify who is going to
generate, approve and authorize these documents.
19. 11)SOPS:
List of SOPs relatedto validation activities
including those of calibration activities also.
12)Training requirements:
Identify all persons who are responsible for
carrying out various validation activities and
their training needs and comment on how these
need will be satisfied.
