VINDAIR ENGINEERS PVT.

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VALIDATION MASTER PLAN
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VALIDATION MASTER PLAN

FOR THE

CLEANROOM FACILITY OF VINDAIR

This Document Containing 15 Pages is Prepared, Approved and authorized by the following
personnel.

FUNCTION DEPARTMENT DESIGNATION NAME SIGN AND DATE

Prepared By Services

Checked By

Approved by

REVISION NO. CHANGES INCORPORATED EFFECTIVE DATE

R0 New Validation Master Plan introduced

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TABLE OF CONTENTS
Sr. No. Description Page No.

1.0 Introduction 05

2.0 Purpose 06

3.0 Scope 06

4.0 Validation Process 06

5.0 Validation Philosophy and approach 07

6.0 Validation Team Members 08

7.0 Risk Analysis and Impact Assessment 10

8.0 Key Elements of Validations 11 - 14

9.0 Qualification Process and Elements of Qualification 14

10.0 Approach for new instrument validation 15 - 17

11.0 Vendor Qualification 18

12.0 Support Programmes 18 - 19

13.0 Validation Review 19

14.0 Actions to be taken following Test Failures 20

15.0 Personnel Qualification 20 - 21

16.0 Training 22

17.0 Review and approval of VMP 23

18.0 Annexure List 23

19.0 Glossary 24 - 25

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1.0 INTRODUCTION:

is a Bangalore based company engaged in offering projects, turnkey clean room solutions, and
services. It has rich experience in the field of simulation, treatment, contamination control of
indoor environment for air and do provide complete clean room air control, simulation,
Commissioning, TAB & validation services to the esteemed customers.

was established in 2004, with three specific service divisions to provide complete turnkey
solutions to clean room Civil, structural, HVAC, Electrical, Automation, facility commissioning &
TAB, validation and qualification services for clean rooms

Over the year of experience in the clean room build, design, commissioning and validation, we
have thoroughly understood the intricacies of the clean room air control, simulation, validation
and qualification services in sync with the current standards required by various user industries
like: Pharma, Health care, Manufacturing sectors … etc. and with the experience of our own team
of engineers and the help of industrial users we have developed the procedure, systems as per
the standard for various equipments / systems for the above industries.
2.0 PURPOSE:
Validation Master Plan (VMP) is a dynamic, instructive, commitment document, which
summarizes, overall philosophy, intent and approach to be used for establishing performance
adequacy by means of Validation program of its own projects, other services in house and at site.
FREQUENCY OF REVIEW: MINIMUM ONCE IN TWO YEARS.
3.0 SCOPE:
This VMP covers the Validation of the clean rooms and clean room accessories, which needs to be
in validated state and delivering the consistent output to maintain the customer specific parame-
ter requirements to maintain good quality of product, directly or indirectly produced in the facil -
ity. It identifies the scope of validation and the extent of such testing as per the applicable stan-
dards, Standard Operating procedures and frequencies.
This VMP addresses Documentation requirements during validation, change control, periodic
review of project implementation, Instrument Qualifications, Risk and impact Assessments and
training of personnel involved in the qualification and validation activities.
4.0 SERVICES PROCESS:
– Services Division”, is dedicated team of experienced engineers to provide comprehensive
solution to Project Material Quality, Quality Installation at site, Facility Commissioning, TAB,
Validation and Qualification for your clean room facility.
"Our Customer is our business. We must provide innovative services that excite our customers
and exceed their expectations of quality, features and enduring value. We will consistently

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provide the highest quality services in every market we serve. Our name will signify reliability and
quality to the countless people who use our services."
Over the year of experience in the clean room build, design and validation, we have thoroughly
understood the intricacies of the clean room air control, simulation, validation and maintenance
services in sync with the current standards required by various user industries like: Pharma,
Health care, Manufacturing sectors … etc. and with the experience of our own team of engineers
and the help of industrial users we have developed the procedure, systems as per the standard
for various equipments / systems for the above industries.
5.0 SERVICES PHILOSOPHY AND APPROACH:
The Services approach is to review the design, maintaining quality in material supply & installation
of the system at project site, facility commissioning and TAB, validate/qualify as per
client/customer requirement.
The basic approach towards validation / qualification is as follows:
Qualification / Validation shall be carried out as per written, approved and authorized SOPs
Our Services activity plan consists of the following:
a) Facility Design Review with respect to URS & Basis of Design at project site
b) Quality Control in Supply of Material/Equipment
c) Quality Assurance in Site Installations.
d) Preparation & Execution of Installation, Operation & Performance Qualification as per cGMP
Guidelines and Customer requirement
e) Clean room Facility Commissioning by means of installation checks, pre-functional checks,
system start up checks and system functional tests.
f) Preparation and approval of Validation Protocol and approval from the customer.
g) Clean room Facility Performance Tests Execution and validation report preparation
h) Submission of Reports and system handover after approval from customers.
We are very specific on design qualification and installation shall start only after prior approval of
the design we proposed from Customer.
Preparation and execution of Facility Qualification documentation shall be taken care in
consultation with customer.
Validation is started, only when specific, approved, validation protocol or SOP is available and
issued.
For every new project or up gradation of an existing facility (to upgrade the same), the validation
activities shall be carried out as defined in the respective Validation Plan for such projects.
Any deviations observed during the validation shall be investigated through quality management
system, impact assessment shall be done and the rationale shall be developed.

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All validation documents shall be archived in secure locations as a

permanent document for one year.
Preventive Maintenance Plans (PMP): Planned PMPs (including periodic calibration of
instrument) as per SOPs shall be available to keep all instruments, in validated state.
Training and Education: All personnel involved in the testing of validation are trained regularly on
cGMP and SOPs.
6.0 SERVICES TEAM MEMBERS:
The responsibility of qualification and validation is multi-disciplinary in nature. Team members
from various relative disciplines comprising, but not limited to, the following will perform the
qualification/validations:
Team Leader - Operations
Group Leader/Engineers – QA, QC & Documentation
Group Leader/Engineers – Commissioning & TAB
Group Leader/Engineers – Validation
Technicians –Commissioning, TAB & Validation
In addition to these members, any other representatives from contactors and vendors will also be
a part of the validation team.
VALIDATION TEAM RESPONSIBILITIES:
Members from all departments will participate in planning and execution of VMP based on their
respective area of operations. Heads Services, Services Quality Assurance, and Client
Representative will review and witness the tests or document approval; as the case may be
approval of QA is a must for all quality related documents. It is the responsibility of team leader of
validation execution to define the responsibility of its team member and of external contractors in
the qualification and validation programme.
The core responsibilities of the validation team are;
- To create, update and review/approve validation plans and deliverables.
- To ensure validation compliance with respect to the Validation Master Plans (VMP).
- Approve Qualification / Validation procedures and plans.
- To ensure, implement, and verify all elements of the VMP, to evaluate and approve changes,
if any during the execution.
- Review the test results and make recommendation for approval.
- Assess risks and develop contingency plan.
QUALITY ASSURANCE TEAM:
Quality Control and Assurance Team member shall coordinate the entire validation process by
scheduling meetings and discussion with other team members. The QA member shall ensure the
release of relevant protocols, training, monitoring of validation process, compiling and analyzing
validation data and test results and preparing final report. He/She shall also coordinate with the
equipment suppliers and contractor for the completion of relevant Equipment Qualification
documentation. The QA Group Leader shall provide necessary GMP training to all involved in
qualification and validation. He/She shall ensure retention of records related to qualification and

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validation of instruments used for the validation and the validations done at customer site.
(Control of documents either by soft copy or by Hard copies) retention of the documents for
validation done at site shall be maintained for one year.
Instruments used for the validation shall be qualified on the receipt of the new equipment and
periodically qualified once in Two years.
All master instruments shall be calibrated once in a year.
RISK ANALYSIS (RA) AND IMPACT ASSESSMENT:
RISK ANALYSIS:
Purpose of Risk Assessment is to identify critical and non-critical validation activities. By
conducting Risk Assessment it is confirmed whether the risks are acceptable for the cGMP
requirement. Risk analysis identifies the activities necessary for calibration, maintenance and
validation.
IMPACT ASSESSMENT:
Before identifying the type of qualification / validation, all systems need to be evaluated for the
impact such a way that whether it can have the impact on the predetermined specification of the
system.
ASSESSMENT OF NEED TO VALIDATE:
Validation assessment shall be made based upon the predetermined validation plan and area
criticality. To asses the system validation trend shall be maintained, if required same can be
produced based upon the customer requirement.
DEFINITION OF VALIDATION:
Establishing documentary evidence, which provides high degree of assurance that a specific
process will consistently produce a product, meeting the predetermined specifications and quality
attributes.
KEY ELEMENTS OF CLEANROOM VALIDATION:
AIR VELOCITY TEST:
This test is performed to determine the supply airflow rate in a non-unidirectional clean room and
the air velocity distribution in a unidirectional clean room. Typically, either airflow velocity or
airflow rate testing will be performed, and results will be required in only one format: average
velocity, average airflow rate or total airflow rate. Total airflow rate may, in turn, be used to
determine the air exchange rate (air changes per hour) for a non-unidirectional installation.
FILTER INTEGRITY TEST:
These tests are performed to confirm that the final high efficiency air filter system is properly
installed by verifying the absence of by pass leakage in the installation, and that the filters are free
of defects (small holes and other damages in the filter medium and frame seal) and leaks (bypass
leaks in the filter frame and gasket seal, leaks in the filter bank framework). The tests are

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performed by introducing an aerosol challenge upstream of the filters and scanning downstream
of the filter sand support frame or sampling in a downstream duct.
NON VIABLE PARTICLE COUNT AS BUILT, AT REST, OPERATION:
The purpose of this test is to measure the quantity (number or mass) or the effects (light scatter
or area coverage) of particles deposited upon surfaces at any orientation.
TEMPERATURE AND HUMIDITY TEST:
The purpose of these tests is to demonstrate the capability of the clean room air-handling system
to maintain air temperature and moisture (expressed as relative humidity or dew point) levels
within the control limits over the time period specified by the customer for the area being tested.
PARTICLE COUNT RECOVERY TEST:
The recovery test is performed to determine whether the installation is capable of returning to a
specified cleanliness level within a finite time, after being exposed briefly to a source of airborne
particulate challenge.
CONTAINMENT LEAKAGE TEST:
This test is performed to determine if there is intrusion of unfiltered air into the clean room or
clean zone(s) from outside the clean room or clean zone enclosure(s) through joints, seams,
doorways and pressurized ceilings.
SOUND LEVEL MEASUREMENT:
This test is performed to determine that the system generates the noise level of with in the design
specifications or pre determined acceptance criteria.
LIGHT LEVEL ( LUX INTENSITY MEASUREMENT):
This test is performed to determine that the inside the clean room Lux level (Light Level) is
maintained as per the design or pre determined acceptance criteria.
PRESSURE BALANCING:
The purpose of the air pressure difference test is to verify the capability of the clean room system
to maintain the specified pressure differential between the installation and its surroundings. The
air pressure difference test should be performed after the installation has met the acceptance
criteria for airflow velocity or volume, airflow uniformity and other applicable tests
CHILLED WATER / CONDENSER BALANCING:

AIRFLOW DIRECTION TEST AND VISUALIZATION

The purpose of this test is to confirm either the airflow direction or airflow pattern or both in
regard to the design and performance specifications. If required, spatial characteristics of airflow
in the installation may also be confirmed.
CONTAINMENT LEAK TEST

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This test is performed to determine if there is intrusion of unfiltered air into the clean room or
clean zone(s) from outside the clean room or clean zone enclosure(s) through joints, seams,
doorways and pressurized ceilings.
TEST REPORTS
The result of each test shall be recorded in a test report, and the test report shall include the
following information:
a) Name and address of the testing organization, and the date on which the test was performed;
b) Number and year of publication of ISO 14644, i.e. ISO 14644-3: date of current issue;
c) Clear identification of the physical location of the clean room or clean zone tested (including
reference to adjacent areas if necessary), and specific designations for coordinates of all sampling
locations;
d) Specified designation criteria for the clean room or clean zone, including the ISO classification,
the relevant occupancy state(s), and the considered particle size(s);
e) Details of the test method used, with any special conditions relating to the test or departures
from the test method, and identification of the test instrument and its current calibration
certificate;
f) Test result, including data reported as specifically required in the relevant clause of and a
statement regarding compliance with the claimed designation;
g) Any other specific requirements defined relevant to the clause for particular tests.
DEFINITION OF QUALIFICATION:
Identification of equipment attributes related to the performance of a particular function or
functions and allocation of certain limits or restrictions to those attributes.
QUALIFICATION PROGRAMME FOR INSTRUMENTS, EQUIPMENTS AND ASSOCIATED
ACCESSORIES:
ELEMENTS OF QUALIFICATION:
Every step of qualification / validation in this VMP is in accordance with the requirements of
current Good manufacturing Practice (cGMP), Schedule M and ISO-14644 guidelines
All Qualification protocol must include the following;
Title page
Pre-approved Qualification protocol (with purpose, scope, responsibilities, execution
team, procedures, general checks, IQ checks, OQ checks, PQ checks, Change
Controls, Deviations, Deficiencies in the system, Preventive maintenance plan,
safety precautions, Abbreviations, calibration requirements, review and summary,
Conclusion and all checks shall be with the verification lists and pre defined
acceptance criteria).
Cross reference to other documents
Review and approval by Quality assurance Team.

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INSTRUMENT / EQUIPMENT QUALIFICATION:

The Team members shall coordinate with all suppliers, contractors and customers
for planning the qualification of master instruments, periodic master instruments
calibrations and validation activities at customer’s site.
Upon receipt of any master instruments to the organization the validation team
member shall ensure the receipt of design specification, (DQ, IQ, OQ, PQ)
maintenance and operation manuals from the instrument suppliers. The team
member shall coordinate with the equipment suppliers and Quality Assurance team
member for preparation of in house IQ, OQ, PQ.
The purpose of new master instruments qualification and validation instruments
calibration provide documentary evidence that;
a) The Master instruments are designed in accordance with the requirement of
current GMP.
b) The Master instruments have been supplied and operational in accordance with
cGMP.
The Team members shall ensure master instruments calibration, preparation of
maintenance programs, and training of operators on the operation and
maintenance of master instruments.
The Team members shall ensure the preparation of Standard Operating Procedure
(SOP) for the operation and maintenance of the individual instruments.
APPROACH FOR NEW INSTRUMENT VALIDATION:
A User requirement specification (URS) and functional specification shall be pre-
pared.
A detailed Design qualification (DQ) shall be prepared and shall be finalized upon
discussion with the supplier / vendor, selected based on the technical capabilities to
meet the URS and functional specification, track record and deliverance.
Validation protocols with acceptance criteria shall be developed with necessary ap-
provals from the validation team and quality assurance team which is used to qualify
or validate the instrument, during/for installation (IQ), operational (OQ) and perfor-
mance (PQ).
Supplier(s)/vendor(s) shall be then called for evaluation of the required instrument.
Draft Standard operating procedures shall be developed during the qualification
program.
After receipt of instrument, Installation qualification (IQ) shall be performed.
After successful IQ, operational qualification (OQ) tests shall be conducted and the
criteria’s mentioned in protocols are checked for adequacy/compliance
If the acceptance criteria are not met, the instrument is again checked for compli-
ance to the same unchanged acceptance criteria. If the problem still exists, the sup-
plier / vendor to be informed to rectify the problem or replacement.

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If the acceptance criteria’s are met, write the validation report and an OQ summary
report.
After successful OQ, performance qualification (PQ) tests shall be conducted and the
criteria mentioned in the protocols shall be checked for adequacy/compliance.
The validation/qualification documents shall be reviewed, approved and authorized
by the validation team and Quality Assurance Team.
All validation/qualification documents shall be archived in secure locations as a per-
manent document.
APPROACH FOR EXISTING (LEGACY) INSTRUMENT:
For those legacy instruments where in necessary modifications or additions have
taken place, without any change in the basic design parameters. Installation
qualification (IQ), Operational qualification (OQ) and Performance qualifications
(PQ) shall be performed.
Impact assessment: Further impact on quality is identified for all Instruments.
Standard operating procedures shall be developed in those cases where the same is
not available and for those, which are available, the same shall be reviewed and
that can be used to qualify or validate the instruments, during validation
qualification (VQ).
VALIDATION QUALIFICATION:
The IQ, OQ and PQ may be combined in certain situations into a single study called a
VQ. These situations typically involve qualification of non-complex equipment or
systems or certain legacy equipment which need to be qualified based on historical
data and these should be approved by the engineering, QA and the user
departments.
RE-QUALIFICATION:
Modification to the instrument should follow satisfactory review and approval of the
change proposal through change control procedure. Instrument Change Control
procedure should include consideration of re-qualification of the Instrument.
Review mechanism shall give due consideration to the requirement of validation
activity to be performed by the instrument.
DOCUMENTATION FORMAT AND NUMBERING SYSTEM:
All documents shall at the minimum bear the title of the document, facility name,
document code, page numbering, signatures of prepare, reviewer, approver and
issuing authorities (where applicable). All signatures shall accompany date.
Procedures on document control, data entry and error correction, record
maintenance shall address the various requirements of formatting, document
numbering, and date of entry, data entry, archiving, and retrieval system. GMP

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Policies on various subjects shall address the GMP requirements to be followed

throughout the Validation Documentation.
VENDOR QUALIFICATION:
Qualification of Vendors for all instruments suppliers shall be followed with the
following steps
 Instrument Supplier Details
 Approved Vendors list for new procurement / calibration of instruments
List of approved vendors shall be maintained.
SUPPORT PROGRAMS:
Each support program for the validation/qualification shall be carried out during the
validation program. Based on the validation reports obtained for the instruments.
The support programs shall be scheduled and executed. The support programs for
validation are as follows:
- Calibration.
- Preventive maintenance.
- Standard Operating Procedures (SOP)
- Change control.
CALIBRATION:
Calibration of the instruments shall be done once in a year. All the calibration
activity to be done by external agency, the same shall be reviewed and approved.
Agencies performing the calibration of master instruments shall be approved and
documented in approved vendor list.
PREVENTIVE MAINTENANCE:
Preventive maintenance is primarily based upon the recommendations of the
instrument Manufacturer. Preventive maintenance schedule will be prepared for
individual instrument and compliance shall be recorded. Preventive maintenance
shall be scheduled during the qualification. The procedures shall be reviewed and
verified during operational qualification based on its performance. The Preventive
Maintenance is done as per an authorized standard operating procedure and
relevant records shall be maintained.
STANDARD OPERATING PROCEDURES (SOP’S):
Standard operating procedures required for each instrument will be identified and
prepared during the instrument qualification programme and checked for its
adequacy during implementation. Subsequently these SOP’s will be reviewed and
authorized. SOP for the entire organization will be prepared as per the SOP: SRP/----
“Guidelines for Preparation of Standard Operating Procedures”
CHANGE CONTROL:

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Change control system will describe the action to be taken if a change is proposed to
a document, instrument and validation at site etc which shall affect the functioning
of the quality or support system operation at customer site. The request will list out
the following;
Description of change proposed, current status, reason and supporting data
justifying the change, nature of change, evaluation of change, comments from
applicable cross functional departments, details of corrective / preventive actions
taken supporting the change and post introduction and corrective actions review.
QA team members shall review the details of change and the decision will be taken
for further calibration or validation/qualification or authorization of activity. This
document will also form the part of validation document specific to the validation
and instrument. Change control procedure shall be adopted in stages as one
proceeds from Design to Performance validation/qualification to incorporate any
change that may be warranted.
VALIDATION REVIEW:
After the completion of the validation activities, the reports shall be reviewed by QA
team member and service engineers to plan out for monitoring the validated
systems.
ACTIONS TO BE TAKEN FOLLOWING TEST FAILURES:
Any test failure during a validation exercise shall be reviewed or analyzed to identify
the origin of their failure. Action to be taken following test failure must be
documented and authorized through the Quality Management System of the
location. Test failures should be considered during the validation exercise as the
more failures that are detected during the validation studies. QA team member
must study the results to identify the reason for failure. The failure may not be due
to the facility operations under test or instruments under use, but may, or due to
isolated incidents.
ACTIONS TO BE TAKEN DURING FAILURE INVESTIGATION:
All failures must be fully investigated and reasons for the failure is documented. It
is not satisfactory to repeat a qualification test if the reason for failure is unknown.
Actions to be taken once the source of the defect has been identified will depend
upon the source. For failures due to incomplete or sub standard installation during
IQ or early stages of OQ, authorized remedial action may be taken, and the test
repeated. When investigating the reason for failure, it may be best to suspend the
validation work and to conduct an investigation that includes a series of tests that
will help to define the operating parameters, sampling plan or testing conditions.
The results should be reported separately from the validation work but may be
referenced in a revision of standard operating procedures or protocols.
PERSONNEL QUALIFICATION:
PHYSICAL FITNESS:

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Pre-employment medical test is carried out for the new employees before they are
employed. After that, annual medical check up is carried out for all the employees as
per the approved procedure.
KNOWLEDGE:
Employee training programs are conducted to create and update self- awareness,
improving of the working skill and overcoming of their identified deficiencies.
Training is also necessary to ensure uniform systems (Quality Systems) and
objectives of the Company. There is a comprehensive training programme. In-house
experts are conducting in house training programme to all the officers. We invite
external experts to support our training programme too.
Each employee on joining the company will undergo induction training program to
familiarize him/her with the activities of organization and to know the requirement
of related activities. Training need of the employees will be identified by the
department heads. Apart from technical training, specific cGMP training will be
imparted to all personnel involved in Validation Services and Quality Assurance.
The effectiveness of the training will be assessed and the same will be documented
for each one who undergone training. Evaluation of training shall also be done by
observation of employee at the work place (on the job) and also formally by
continual assessment based on written questionnaires. Training records of each
employee will be maintained after signing by the trainee and certified by the trainer.
All the personnel concerned with an instrument will be trained in minimum for the
following, apart from other related GMP aspects;
Components and critical parts of the instrument and validation activities
Preventive Maintenance and Operation Procedures for Validation activity
Various operating controls and precautions to be taken during operation of
instrument
Safety controls and features of the instrument.
Detailed awareness of the validation activity
Guidelines awareness and SOPs.
TRAINING:
TRAINING PROGRAM:
An overall training program must be described in a general procedure. Training
program is required for each job classification. The program must include GMPs,
SOPs, Guidelines, Documentations, etc. The trainee should progress through all
stages of training before being "certified" to perform the job. Each training event
shall be fully documented and signed by the trainee, trainer and direct supervisor.
BASIC REQUIREMENTS:
All personnel hired to work at the facility shall have adequate technical and
educational backgrounds. All personnel must complete the training program

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specific to their assignment. Personnel who have not completed the required
training program shall not be allowed to perform the job.
GOOD MANUFACTURING PRACTICES (GMP):
The training program shall require that all personnel participate in GMP training.
All personnel are expected to conduct themselves in a manner consistent with GMP
operation at customer sites.
STANDARD OPERATING PROCEDURES (SOP):
All personnel shall be trained on general procedures so that there is an
understanding of the overall instrument operations, documentations, validation
principles and guidelines etc.
TRAINING RECORDS:
Training events shall be documented (i.e. Course identifier, instructor, date,
participant name) and/or qualifications of personnel involved. The training records
shall be retained by the QA team.
MAINTENANCE AND OPERATION PROCEDURE:
These procedures shall address actions to support the preventive and corrective
maintenance for all instruments used for the validation activity.
Calibration Procedures:
These procedures shall detail the actions to either calibrate or check the calibration
of instruments where the accuracy and repeatability of control settings and or
operating parameters are within limit.
REVIEWS AND APPROVAL OF VMP:
The Review and Approval section of the VMP is intended to ensure that the contents
of the VMP are accurate and that they cover all of the relevant issues to ensure that
the instruments and validation activity are in compliance with cGMP and ISO 14644,
Schedule M requirements. Key team members are from Services Quality Assurance,
Services Validation Team, Head Services and Director Services.
ANNEXUERES:

1. Quality policy
2. Services Planning
3. Corrective and preventive action
4. Organization Chart
5. Service Flow Chart
6. Employees Qualification Levels, Job Responsibility and technical skills
7. Instrument Master Lists, Operating Procedure, master instruments
calibration, log books, PMP and planner, Brake down maintenance, History cards
8. Validation and testing procedures
9. Trainings
GLOSSARY:

CLEANROOM

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Room in which the concentration of airborne particles is controlled, and which is

constructed and used in a manner to minimize the introduction, generation and
retention of particles inside the room, and in which other relevant parameters, e.g.
temperature, humidity and pressure, are controlled as necessary
CLEAN ZONE
Dedicated space in which the concentration of airborne particles is controlled, and
which is constructed and used in a manner to minimize the introduction, generation
and retention of particles inside the zone, and in which other relevant parameters,
e.g. temperature, humidity and pressure, are controlled as necessary
AEROSOL GENERATOR
Instrument capable of generating particulate matter having appropriate size range
(e.g. 0,05 μm to 2 μm) at a constant concentration, which may be produced by
thermal, hydraulic, pneumatic, acoustic or electrostatic means
DESIGNATED LEAK
Maximum allowable penetration, which is determined by agreement between
customer and supplier, through a leak, detectable during scanning of an installation
with discrete-particle counters or aerosol photometers
INSTALLED FILTER SYSTEM LEAKAGE TEST
Test performed to confirm that the filters are properly installed by verifying that
there is absence of bypass leakage in the installation, and that the filters and the
grid system are free of defects and leaks
STANDARD LEAK PENETRATION
Leak penetration detected by a discrete-particle counter or aerosol photometer
with a standard sample flow rate when the sampling probe is stationary in front of
the leak
AIR EXCHANGE RATE
Rate of air exchange expressed as number of air changes per unit of time and
calculated by dividing the volume of air delivered in the unit of time by the volume
of the space
AVERAGE AIRFLOW RATE
Averaged volume of air per unit of time, to determine the air exchange rate in a
clean room or clean zone
UNIDIRECTIONAL AIRFLOW
Controlled airflow through the entire cross-section of a clean zone with a steady
velocity and approximately parallel streamlines
AEROSOL PHOTOMETER

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Light-scattering airborne particle mass concentration measuring apparatus, which

uses a forward-scattered light optical chamber to make measurements
DISCRETE-PARTICLE COUNTER: DPC
Instrument having a means of displaying and recording the count and size of
discrete particles (with a size discrimination) for specific air volume condition where
the installation is complete with all services connected and functioning but with no
production equipment, materials, or personnel present
AT-REST
Condition where the installation is complete with equipment installed and operating
in a manner agreed upon by the customer and supplier, but with no personnel
present
OPERATIONAL
Condition where the installation is functioning in the specified manner, with the
specified number of personnel present and working in the manner agreed upon.

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