VALIDATION MASTER PLAN 2014 (VMP)

Document No. : VMP/14/001

Revision No. : 00

Supersedes : None

Effective Date :

Review Date :

Page No. : 1 of 26

SAMRUDH PACKAGING PVT. LTD.,

G-16/2 &3, MIDC, Tarapur, Boisar, Thane-401 506.
Maharashtra, India

APPROVALS

F/QAD-006/01
 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
Page No. : 2 of 26

Approval of this Validation Master Plan indicates agreement with the strategies and principles as outlined,
and commitment to support the ongoing validation activities of Samrudh Packaging Pvt. Ltd., India.

Following signatures signify review, approval and authorization of this plan.

Functional Areas Name Signature Date

Prepared By
(Officer QA)

Reviewed By
(Production Incharge)

Reviewed By
(Quality Control Incharge)

Reviewed By
(Engineering Incharge)

Approved By
(QA Incharge)

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006/01
 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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TABLE OF CONTENTS

Sr. No. Table of Content Page No.

1.0 Objective 6
2.0 Introduction 6
3.0 Scope 7
4.0 Validation Team & Responsibilities 8
4.1 Samrudh Packaging Pvt. Ltd. Validation Team 8
4.2 Production 8
4.3 Engineering 9
4.4 Quality Assurance & Quality Control 9
5.0 Qualification / Validation Overview 10
5.1 Flow Chart for Qualification Activity 11
5.2 Design Qualification 12
5.3 Commissioning 12
5.4 Installation Qualification 13
5.5 Operational Qualification 13
5.6 Performance Qualification 14
6.0 Process Validation (PV) 15
7.0 Cleaning Validation (CV) 17
8.0 Validation Requirements 18
8.1 Production Equipment / Utilities 18
8.1.1 Utility Qualification 19
8.2 Validation in Quality Control (QC Instruments) 20
9.0 Control System Validation / Computer Validation 21
10.0 Premises Validation 21
11.0 Personnel Validation 22
12.0 Vendor Audit 22
Sr. No. Table of Content Page No.
13.0 Supportive cGMP Programmes 22
13.1 Standard Operating Procedures (SOP) 22
13.2 Change Control 23
13.3 Annual Product Review 23
13.4 Deviations 23
14.0 Training and Personnel Qualification 23
15.0 Calibration and Preventive Maintenance 24
16.0 Revalidation / Requalification 25
17.0 Revision Control 26
18.0 Reference 26

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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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ANNEXURE DETAILS

SR. NO. DOCUMENT NAME ATTACHMENTS

PRODUCTION EQUIPMENT MATRIX AND ANNEXURE I

01. (F/QAD-006/02)
QUALIFICATION STATUS.
QC INSTRUMENT MATRIX AND QUALIFICATION ANNEXURE I
02. (F/QAD-006/02)
STATUS.
MICROBIOLOGY EQUIPMENT/INSTRUMENT MATRIX ANNEXURE I
03. (F/QAD-006/02)
AND QUALIFICATION STATUS
SYSTEM/UTILITY MATRIX AND QUALIFICATION ANNEXURE I
04. (F/QAD-006/02)
STATUS.
CALIBRATION SCHEDULE OF QUALITY CONTROL ANNEXURE II
05. (F/QCCAL-001/04)
AND MICROBIOLOGY DEPARTMENT.
ANNEXURE III
06. PREVENTATIVE MAINTANANCE SCHEDULE
(F/ENGEN-001/01)
PROCESS VALIDATION STATUS MATRIX ANNEXURE IV
07. (F/QAD-005/01)
PRODUCTWISE
MASTER VALIDATION SCHEDULE FOR THE YEAR ANNEXURE V
08. (F/QAD-006/03)
2014 FOR HVAC SYSTEM

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006/01
 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
Page No. : 5 of 26

1.0 OBJECTIVE
Objective of this VMP is to provide the written plan establishing the validation approach to be
followed to assess the facility, systems, methods, equipment, instruments, training and document
the same.
This VMP is written to identify the following-
o Sequences of activities
o Resources
o Responsibility
o Equipment / Facility/Systems / Methods / Training which will need to be considered for
assessment.

2.0 INTRODUCTION

“Samrudh Packaging Pvt. Ltd.” is an Indian pharmaceutical company established in the year
2013.
“Samrudh Packaging Pvt. Ltd.” is the manufacturing site for manufacturing of External Dosage
Form ( Ointment & Suppository). The plant was started in the year 2013.
The plant is well equipped and self-reliant. The utilities are appropriately set-up and meet the
Production requirements.
This Validation Master Plan (VMP) documents the overall philosophy, intentions, validation
approach, organizational structure and approach taken by “Samrudh Packaging Pvt. Ltd.” to
establish performance adequacy. This VMP is reviewed and revised periodically at every
Three years to assure that the site validation activities and status is kept current.
Approval of the Validation Master Plan signifies agreement with the validation strategy as outlined
and support for the ongoing control and maintenance of the Samrudh Packaging Pvt. Ltd..
The following topics will be discussed in this Validation Master Plan:
 A qualification / validation overview and approach, including a general discussion of the
philosophy and definitions of what constitutes the Qualification/ Validation Package, Installation
Qualification, Operational Qualification and Performance Qualification.
 The qualification of specific items of equipment, utilities and methods.
 Validation of manufacturing processes and cleaning procedures.
 Additional programs such as Documentation, SOPs, Change Control, Annual Product
Review, Deviations, Training, Calibration and Preventive Maintenance and Revalidation.

2.1 CONCEPT OF VALIDATION

Validation ensures that chances of deviation in actual operations are reduced to an achievable
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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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lowest level and high degree of assurance that the specific process / equipment / facility system will
consistently perform to its predetermined requirements is attained, when performed within given
parameters.
2.2 PHILOSOPHY AND APPROACH
Validation is an essential requirement of current good manufacturing practice (cGMP) and is a
primary requirement of quality assurance system. Documentation is the key ingredient of validation.
Validation Master Plan will cover the basic validation needs of the organisation. The plan is
necessary to ensure validity of the QA system in the organisation.
2.3 VALIDATION POLICY

All the critical systems, equipment, procedures and processes shall be validated with a view to
establish, assure and provide documentary evidence that they consistently perform as per the
design, comply all specifications and satisfy all predetermined requirements, when performed.

3.0 SCOPE
This Validation Master Plan documents the approach that is taken by the site to qualify the
products manufactured and the manufacturing equipment and supporting utilities/systems
contained within the facility.
This Validation Master Plan cover the operations carried out at drug facility of “Samrudh
Packaging Pvt. Ltd.” situated for manufacturing of finished pharmaceutical product at:
SAMRUDH PACKAGING PVT. LTD., G-16/2 &3, MIDC, Tarapur, Boisar, Thane-401 506.
Maharashtra, India.

This Validation Master Plan is the guideline for the approach taken in:
 Production Equipment Qualification,
 Utilities / Services Qualification,
 Laboratory Equipment Qualification ,
 Process Validation (PV),
 Cleaning Validation study (CV),
 Analytical Method Validation
 Microbiology Method Validation.
 Process control/ PLC validation
 Personnel validation
 Vendor qualification
The approach discussed in this document applies to all the qualification/validation activities to
be carried out at the site from the date effective.

F/QAD-
006/01
 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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The VMP defines responsibilities; the areas addressed, outline the programs applicable to this
facility, responsibilities, lists the equipment/utility systems qualified, and lists key activities for
major equipment/utility systems.

4.0 VALIDATION TEAM AND RESPONSIBILITIES

Validation is a cooperative effort between Quality Assurance/Quality Control, Production and
Engineering; the following is Validation Team for Samrudh Packaging Pvt. Ltd..
4.1 SAMRUDH PACKAGING PVT. LTD. VALIDATION TEAM
The validation team is responsible for carrying out the site validation activities. The team shall
comprise the Head personnel from following functions:
1) QA
2) Production
3) Engineering
4) Quality Control.
5) Any other department personnel required, as per the specific validation project needs,
such as Warehouse.
The responsibilities of the members of validation team are detailed below:

4.2 PRODUCTION
The Production Incharge or designee is responsible for ensuring the qualification of equipment and
validation of processes used within the department. These responsibilities include
 Review Validation Master Plan.
 Execution and review of validation/qualification protocols and reports, as required.
 Ensuring the execution of validation/qualification as per the sequence given in the protocol.
 Provision of resources for the operation of equipment during qualification studies.
 Manufacture in accordance with the validated processes.
 Review of Validation and qualification reports.

4.3 ENGINEERING

The responsibilities of the Engineering Department include

 Review Validation Master Plan.

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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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 To ensure the measuring instrument and equipment are in calibrated state.

 Execution of validation/qualification protocols, as required.
 Supply support documentation for equipment/utility qualification.
 Provide technical assistance in protocol execution as appropriate.
 Review of Validation / qualification reports.
 The maintenance and calibration of production facilities and instrumentation, utilities
and air handling systems.
 Maintain equipment qualification related documents.

4.4 QUALITY ASSURANCE & QUALITY CONTROL

4.4.1 QUALITY ASSURANCE

 Responsible for the co-ordination of all the validation activities at the site.
 Preparation of Qualification, process and cleaning validation protocols/report in co-
ordination with concerned department.
 Preparation of validation schedules.
 Maintain the completed and approved process related validation documentation.

4.4.2 QUALITY CONTROL

 Responsible for validation activities of laboratory equipment/instrument.
 Develop and review relevant validation protocols and reports.
 Manage the laboratory testing necessary for protocol execution.
 Develop, review and approve departmental Sops as appropriate.

4.4.3 QA INCHARGE
 Review and approve Site Validation Master Plan and schedules.
 Review and approve validation protocols and reports.

5.0 QUALIFICATION / VALIDATION OVERVIEW

Validation is a significant part of the Samrudh Packing Pvt. Ltd. quality program. The purpose of
the validation program is to establish documented evidence that provides a high degree of
assurance that the processes will consistently produce materials meeting predetermined quality
characteristics.

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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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The qualification/validation program implemented by the Samrudh Packing Pvt. Ltd. facility shall
be consistent with this Validation Master Plan, and the intent of the cGMPs defined by ICH: Q7A.
Old equipments, which have not undergone qualification when they were commissioned, shall
retrospectively qualified.
Qualification and Validation documentation will consist of a predetermined selection from the
following:
 Design Qualification report (Shall not be part where Retrospective Qualification)
 Installation Qualification (IQ) protocols and reports
 Operational Qualification (OQ) protocols and reports
 Performance Qualification (PQ) protocols and reports (Process Validation document may
replace it)
 Process Validation (PV) protocols and reports
 Analytical Method validation protocols and reports
 Cleaning Validation (CV) protocols and reports

Validation Approach:
Our basic approach is:
 Establishing User Requirements Specification (URS)
 Review of Functional Specification
 Designing of Validation Protocol
 Implementation of Validation activities
 Review and assessment of data
 Certification

Note : The Vendor documents (DQ, IQ & OQ) shall be consider for Qualification purpose after
satisfactory review from all the concern department and verified by QA.

5.1 Flow Chart for Qualification Activity-

USER REQUIREMENT SPECIFICATIONS

DESIGN QUALIFICATION

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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INSTAL LATION AND OPERATIONAL QUALIFICATION (NO PRODUCT)

Equipment verification.
Equipment Calibration
Equipment Documentation

Performance Qualification

PROTOCOL PREPARATION (MINIMUM 2 PRODUCT RUNS)

Product Equipment
Performance Performance Challenge test
Evaluation (Wherever Required)

Process Validation

CERTIFICATE
Documentation Compilation
Review and Approval

Routine Manufacturing

Change Control Procedure

(Required if any)

5.2 DESIGN QUALIFICATION

The equipment / system then shall be subjected to order. Wherever appropriate, design
qualification (DQ) of the equipment shall be carried out before accepting the equipment for
installation.
The equipment / system / facility shall be installed with support of vendor at its designated
location. All the required utilities shall be identified and supported to the equipment / system /
facility based on P&ID.

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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The design of equipment visually verified and crosschecked physically, If in case of absence of
documentary evidence.
Where appropriate, a review of the developed design shall be done to ensure that cGMP
compliance has been addressed at the design stage:
 Compliance with cGMP requirement
 Practical validation tests are possible
The above requirements are ensured through documented review of following documentation,
where appropriate:
 Supplier manual / Technical document.
5.3 COMMISSIONING
All systems and equipment require commissioning to be completed and documented.
Commissioning is the documented evidence of the physical completion of the facility, mechanical
completion of equipment, installation and connection to utilities, and the proof of systems
operations. The commissioning process ensures that systems have been installed and functionally
tested, and are capable of being operated and maintained to perform in conformity with the design
intent.
Typical Commissioning requirements include the following where appropriate: Installation
Inspection, Cleaning Inspection, Component Settings, Utility Connections, Start-up and Shutdown
Sequence Testing, Alarm/Interlock Testing.
All the new equipments installed in the facility will undergo commissioning process.

5.4 INSTALLATION QUALIFICATION

Installation Qualification (IQ) is documented verification that all key aspects of the equipment,
instrument or ancillary systems have been properly selected and constructed, that they are installed
in accordance with the design requirements and established specifications.
The IQ protocol shall define the responsibilities, procedures, documentation, references,
acceptance criteria, deviation and requalification criteria to be used in installation of the
equipment/system.
The IQ protocol shall contain a description of the system, including a discussion of intended
use and major components. The execution of the protocol verifies the system's static
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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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attributes against the user and manufacturer’s specifications prior to normal operation. The
system shall examine for proper connection and installation of supporting services for
example, compressed air and electricity etc. Model, serial numbers and equipment
identification numbers of equipment and major subsystems of each piece of equipment is
recorded. Material of construction shall verify for product contact surfaces. Drawings are
checked during IQ execution.
Critical supporting documentation, such as manufacturer’s manuals, vendor test results,
purchase orders, specifications, drawings and any other required documentation are verified
as available and the file locations noted. All instruments are identified during IQ and
calibration completed prior to the start of OQ.
Standard Operating Procedures (SOP) for Operation, Preventative Maintenance and Cleaning
shall be identified.
Variances encountered during IQ execution shall identify and documented in a variance sheet,
investigated and an appropriate course of action taken is documented.
A summary of IQ is written at the completion of IQ for review and approval before
proceeding to OQ. The IQ documents the existing system/equipment installation.

5.5 OPERATIONAL QUALIFICATION

Operational Qualification (OQ) is documented evidence establishing confidence that the equipment,
instrument or ancillary systems operate as intended and are capable of consistent operation within
established specifications.
After successful completion of the IQ, the OQ protocol is executed. The OQ describe
operational tests and measurements of key parameters critical for the proper operation of the
system. Test objectives, methodologies and acceptance criteria shall defined in the pre-
approved OQ. Controls are manipulated to test the ability of the system to provide adequate
control over variables specific to each piece of equipment. By the conclusion of OQ, SOPs
exist at a minimum, in final draft format for review and approval. As part of the OQ process,
Operator and Maintenance Personnel training occur and shall documented in the protocol.
Variances encountered during the OQ are identified. Appropriate corrective actions are taken
to allow validation to proceed.
Any change(s) made to the system/equipment during the OQ must be documented in the OQ
report. Any changes proposed after the OQ (during performance qualification or routine
manufacturing) must be managed through the Change Control system in accordance with the
Change Control SOP NO: SP/QA/SOP-012.
A summary report is written at the completion of OQ for review and approval before
proceeding to PQ or PV, as applicable.

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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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5.6 PERFORMANCE QUALIFICATION

Performance Qualification (PQ) is documented evidence that the equipment, instrument or ancillary
systems, when operating in its environment and under stress scenarios performs as intended in
meeting pre-determined specifications.
The PQ shall not proceed without completion of the IQ/OQ execution. The PQ integrates
procedures, personnel, materials, utilities, equipment and supporting controls, as necessary.
Test objectives, methodologies and acceptance criteria are defined and approved prior to
execution. Where appropriate, a sufficient number of replicate studies are performed to
determine the ability of the equipment and supporting controls to achieve reproducible
results. Utilities testing may include capacity and quality measurements under actual
operating conditions. The protocol may incorporate load challenges to the intended
operating range of the equipment/supporting controls.
Any variance encountered during the PQ is identified for review. Exceptional conditions are
investigated and the appropriate corrective actions shall taken. PQ summary report shall
write for review and approval.
PQ can be verified in the process validation document and whenever required, PQ can be
performed separately.

6.0 PROCESS VALIDATION (PV)

Process Validation is to "establish documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product meeting its predetermined
specifications and quality attributes."
Process validation is the scientific study of a process to establish that the process is performing to
give the desired end results / product and is under control at all stages of process when performed
within given parameter. Process validation helps to set process variables with their acceptable
variability limits and finally to set up in-process controls and limits of parameters and product.
The manufacturing processes of new products at the site shall be validated, the process shall be
revalidated in case of change in equipment, process, vendor, testing parameter or change in batch
size (if required by customer and the same has been mentioned in agreement but not applicable for
regulated market) to ensure that existing procedures, in-process controls and overall quality system
are adequate in controlling the manufacturing process and ensuring quality of the final product.

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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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In general process validation protocol will contain the following items but not limited to:
 Objective and Scope
 Validation team and Responsibility
 List of Equipment
 Batch Details subjected for validation.
 Manufacturing Process in Brief
 Process Flow Diagram
 Critical process parameters.
 Critical quality attributes.
 Sampling & Testing Plan and validation methodology.
 Acceptance Criteria
 Abbreviations.
 Stability Study Requirement
 Deviation, OOS and Recommendation.
 Summary and Conclusion

6.2 PROSPECTIVE PROCESS VALIDATION:

Validation conducted prior to the distribution of a product made under a revised manufacturing process,
where the revisions may affect the product's characteristics.
For prospective process validation, a minimum of three consecutive successful lots are
evaluated to meet pre-determined acceptance criteria. The sampling and testing plan is based
on an evaluation of the process to be validated with designated critical process steps receiving
the most attention.
As a prerequisite to process validation, all equipment, measuring instruments the utility and
analytical testing methods to be used required to have been validated. Staff taking part in the
validation work shall be appropriately trained.
Each process validation protocol shall be planned and documented fully in an authorized protocol.
This document shall have the following elements:

6.2.1 PROCESS, PRODUCT AND FACILITY DETAILS:

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It shall include Process Flow diagram, Batch size, BMR, List of Active Raw material and
intermediates, Critical in-process tests, Critical process parameters, Intermediate
specifications, List of Equipment and utilities.

6.2.2 VALIDATION PROCEDURE :

The brief Description of the procedure to be adopted for the validation.
Process and In-process test results evaluation.
Specific process optimization details.
Evaluation of Critical quality attributes.

6.2.3 ACCEPTANCE CRITERIA SHALL BE INCLUDED IN RESPECTIVE

PROTOCOL.

6.3 CONCURRENT PROCESS VALIDATION:

This approach to validation shall be undertaken during actual process of product manufacturing and
shall involve monitoring of critical processing steps and end product analysis to generate data to
establish that the process is under control.
The concurrent process validation is carried out on three consecutive, commercial scale batches.
Documentation requirements are the same as specified for Prospective Validation and the testing to
be carried out in-process and on the finished product will be as specified in approved protocols.
The completed protocols and reports should be reviewed and approved after successful completion
of three batches.

6.4 RETROSPECTIVE PROCESS VALIDATION:

This approach to validation shall be undertaken on products already in commercial distribution and
have a long history of compliance to established standards.
Retrospective product validation may be considered based on statistical analysis of operational and
product quality data from several runs of the product (a minimum 20 consecutive batches) to be
validated. Based on this analysis, one should be able to prove that the product/process is in
control.
Annual product review documents shall replace this requirement.

7.0 CLEANING VALIDATION (CV)

Cleaning Validation provides a high degree of assurance that the cleaning process effectively
and consistently removes product residues to predetermined acceptable levels.

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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 This activity is carried out to provide documented evidence that the procedure being followed for
cleaning of equipment, area and accessories is effective and removes residues of previous product a
predetermined acceptance level, using a well-defined protocol and acceptance criteria. The protocol
shall take into considerations the safety/ toxicity and the difficult to clean molecules as worst case
approach.
 Cleaning validation is also established for the campaign cleaning and hold time study after cleaning of
the equipment using a well defined protocol and acceptance criteria.

7.1 APPROACH
In performing cleaning validation, determination of chemical residue limits of a suitable marker from
product manufactured in the equipments to be cleaned shall generally be employed. When choosing the
marker, a worst case scenario shall be based on following three parameters:
a) Toxicity,
b) Difficulty of cleaning based on active drug solubility in water or Solubility,
c) MAR value/ MACO
7.1.1 In cases where a highly toxic and less soluble compound is contained in a product, it shall be chosen
as marker, although additional markers shall be chosen if they are less soluble than the marker selected
based on toxicity.
7.2.2 On each addition of new product, the matrix shall be challenged, MAR value/MACO shall be
calculated for that product and maker substance shall be decided.

However equipment is cleaned after each batch as well as periodically as per the frequencies
defined in SOPs.

8.0 VALIDATION REQUIREMENTS

8.1 PRODUCTION EQUIPMENT / UTILITIES

Qualification is a subset of validation and is documented evidence that provides confidence
that equipment, instruments, facilities, or utility systems have been selected, designed,
installed, constructed and/or operated, as intended, and meets pre-determined specifications.
Utilities, services and equipment scheduled for qualification must be mechanically complete at
the commencement of qualification. The documentation is generated in a sequential manner
that is compatible with the execution of the qualification program.
The list of production equipments, engineering utilities/equipment their qualification status is
attached in Annexure I (Refer F/QAD-006/02).

The entire validation activity will be done in accordance with “v” model described below,

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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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The “V” Diagram

Verification through validation

URS PQ

Verification through SAT

FDS OQ

Verification through
FAT & DESIGN
DQ
IQ

System Design

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 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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8.1.1 UTILITY QUALIFICATION:

8.1.1 Heating, Ventilation and Air Conditioning (HVAC)
8.1.1.1 The intent of this activity is to provide assurance that the HVAC system will operate
properly to provide conditioned air of appropriate cleanliness to achieve the clean
room classification as designed.
8.1.1.2 This exercise will be carried out using a protocol defining the parameters as per
design & verifying the actual installation. Any deviation need to be identified & will
be checked for its impact. The validation frequency shall be once in a year or as per
defined in the validation protocol.
8.1.1.3 Any addition of new HVAC system or major modification in the HVAC system shall
be revalidate at every twelve months.
8.1.1.4 Test Covered during HVAC validation are mentioned below :
Air changes & Air Velocity
Non- Viable Particle Count
Filter Leak Test
Air flow pattern
Recovery & Shoot Up Time
Temperature & RH Monitoring
Pressure Differential
Viable Particle Count
8.1.1.5 Status of utility system validation is attached as Annexure I (Refer F/QAD-
006/02).

8.1.2 Water System:

8.1.2.1 The intent of this activity is to provide assurance that the water system will operate
properly to provide the require grade of water as per the pre defined specifications
at all the user points.
8.1.2.2 The system consists of the sub systems for generation, storage and distribution and
shall be validated initially seasonally as per protocol.
8.1.2.3 Monthly trending of QC parameters shall be reviewed retrospectively and approved
by Quality Assurance.
8.1.2.4 The water system shall be revalidated in case of change in the existing system or
complete validation in case of new addition of newly added generation and
distribution system.
8.1.3 Compressed Air System
8.1.3.1 Compressed air that will come in contact with the product or product containing
equipment at any point of time, shall be generated using an oil free compressor and
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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
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Thane-401 506. Effective Date
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VALIDATION MASTER PLAN (VMP) Review date
Page No. : 19 of 26

will be made moisture free and filtered before use to achieve the desired level of
cleanliness.
8.1.3.2 The system for generation, storage and distribution of oil free compressed air shall
undergo the verification of compressed air quality for evaluating the quality of
Compressed air.
8.1.3.3 Moisture traps are installed to provide moisture free air. 0.02-micron filters are
installed at the user points.
8.1.3.4 Any change in the system shall be gone through engineering verification to evaluate
for its impact.

8.2 VALIDATION IN QUALITY CONTROL (QC INSTRUMENTS)

In order to generate accurate and reliable analytical data for incoming raw materials, in process
and final product release, validated analytical methods and qualified analytical instrument are
used. The laboratory also follows the Good Manufacturing Practices concepts for instrument
maintenance and calibration, reagent and solution preparation, storage and standardization, and
record keeping.
All critical laboratory equipments / instruments undergo installation, operational and performance
qualification, as appropriate. Upon completion of the qualification, these are placed on calibration
and maintenance schedules.
The list of QC equipments/instruments in the laboratory and their qualification status is attached in
Annexure I (Refer F/QAD-006/02).

Qualification of critical analytical instrument HPLC, UV, stability chambers etc- shall be performed
covering installation, operation and performance. This validation may be performed in-house or by
the equipment manufacturer and verified by a responsible site person.

Analytical Method Validation:

The critical test methods that are used for purity and impurity profile testing of finished product
shall be validated covering various relevant parameters: specificity, detection limit, quantification
limit, linearity, robustness (as applicable), ruggedness, accuracy, precision and system suitability.
The methods used for stability testing shall be validated by performing analysis of product subjected
to various stressed conditions and their stability indicating ability shall be established.
Compendial methods used for stability testing shall be validated by performing analysis of product
subjected to various stressed conditions and their stability indicating ability shall be established.
Compendial methods need not be validated but may be verified as appropriate.
Revalidation of Analytical method shall be performed when any change in existing method
conducted.

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
Page No. : 20 of 26

Microbiological method Validation:

- Validation should be performed in accordance with a validation protocol. All the results
should be recorded in the validation report.
- Revalidation should be performed if there are changes in method, instrumentation, reagents,
or product composition.
9.0 CONTROL SYSTEM VALIDATION/ COMPUTER VALIDATION
The validated study was carried out to ensure the error free systems of the software package
to prove that the package is working satisfactorily by M/S. Manufacturing/Representative in
coordination with our IT department.

9.1.1 Programmable Logic Controllers (PLC)

9.1.1.1 PLC systems play a critical role in equipment automation. A form of man machine
interface, these systems helps the user to devise various sequential programs to
control and monitor the equipment or process. The facility has a number of such
systems will be listed and validated by an external agency.
9.1.1.2 A protocol for this validation exercise will be developed by the validation teams or
external agency and reviewed and approved by the members of the Validation team.
10. PREMISES VALIDATION:
Intention of this validation exercise is to verify the facility for following against design,
 Adequacy of Area
 Finishes
 Utilities
 Lighting Level
 Equipment Installed
 Doors & their critical accessories like interlocking etc.
 Access
 Any safety aspect
10.1 Any change in the area due to machine shifting or modification of the existing area shall be
recertified with a checklist as per design & verifying the actual installation for its impact.

11. PERSONNEL VALIDATION:

11.1.1 Adequate training of the operating personnel in hygiene and basic GMP will be
undertaken before the personnel are engaged in manufacturing activities.
11.1.2 The microbiological validation of the personnel after proper training will be undertaken
as per the approved protocol to ensure that the personnel involved in manufacturing
area understand the importance of hygiene, gowning procedures and operational
behaviors in manufacturing areas.

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
Page No. : 21 of 26

11.1.3 Training requirements will be identified by the validation teams for the personnel from
respective functions.
11.1.4 Personnel will be trained in usage of Standard Operating Procedures.
11.1.5 All QC chemists shall be validated as per written SOP as per the frequency stated for
new joined, experienced staff and existing staff. The existing staff shall must covers
within two years for personnel validation.

12. VENDOR AUDIT

Vendors of all active pharmaceutical ingredient as well as Excipients and packaging materials
are assessed. The following steps are the most important aspects of procurement of materials:
 Vendor Approval / Certification
 Vendor pre-purchase sample evaluation
 Vendor audit / developments
 Vendor trial order for stability batch
 Periodic Vendor Audit Re-Certification / De-Certification

Records of vendor audit / approval and subsequent vendor evaluation are maintained. The
purchase department, Quality Assurance manager and Director Operation are responsible for
vendor development / evaluation / Certification / De-certification, which is based on their
performance.

13.0 SUPPORTIVE cGMP PROGRAMMES

13.1 STANDARD OPERATING PROCEDURES (SOP)

To ensure that all operations are performed consistently, written and approved SOPs are
developed. The procedures need to be clear, concise, and written at the anticipated user/
operator level to eliminate any misinterpretation of the operational instruction.
SOP on SOP (SOP No.: SP/QA/SOP-001) demonstrates, Preparation, Approval, Revision and
Control of Standard Operating Procedures address how to write and format SOPs. SOPs are
written to address all activities performed in the facility, including documentation, component
and finished material handling, control of personnel movement, equipment and system
operation, maintenance, cleaning, calibration and personnel training.
13.2 CHANGE CONTROL
A change control program and procedure ensures that equipment, systems and processes remain
in a state of validation. The procedure outlines steps to follow when a change is proposed for a
critical system or process that has been validated.
The change control program ensures that proposed changes are reviewed and approved by
appropriate departmental representatives prior to initiating changes. The review also defines the

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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required tests/study and documentation to be performed to verify that the system, equipment,
and process remain in a validated state.
Change control for qualified equipment / systems and validated processes is carried out in
accordance with SOP No. SP/QA/SOP-012.
13.3 ANNUAL PRODUCT REVIEW
Annual Product Review shall be carried out for Products manufactured during the calendar year to
ensure process tolerance. Annual Product Review shall conduct as per the parameters identified in
SOP.
13.4 DEVIATIONS
The deviations encountered during the execution of process / cleaning validation and protocols
routine manufacturing is handled and investigated through SOP No. SP/QA/SOP-010.
For equipment/utilities qualification, all variances/ deviations encountered during protocol
execution are reported in the qualification protocol with due investigation and corrective
actions taken.
Deviations are the results not meeting the acceptance criteria or mismatches between the
protocol and the physical reality of the system or piece of equipment.
14.0 TRAINING & PERSONNEL QUALIFICATION
An induction-training program is available for all the new experienced recruits to accustom to
the new work environment and systems. Fresh new recruits undergone a vigorous training
under training departments and deputed in relevant areas. Adequate training of the operating
personnel in hygiene and basic GMP will be undertaken before the personnel are engaged in
manufacturing activities.
Job specific training is given to the employees in all activities they are required to perform, as
well as in applicable cGMPs. SOP training is ensured before the procedure is made effective.
All the training is appropriately evaluated and documented.
All QC chemists shall be validated as per written SOP as per the frequency stated for new joined,
experienced staff and existing staff.

Personnel executing the validation protocols are trained on the respective validation protocols
prior to the execution.
15.0 CALIBRATION AND PREVENTIVE MAINTENANCE
A calibration program is available to maintain instrumentation within acceptable operational
limits. The operational limits for calibrated instruments are based on system and processing
requirements. All equipment used to perform calibrations must be calibrated to standards
traceable to the recognized national/ international standards. Procedures relating to frequency

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
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Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
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of calibration, how to calibrate, and documentation of calibrations are available in SOP No:
--SP/QC/GEN/SOP-007. This calibration system apply to all calibration required at the site,
including those performed by Samrudh Packaging Pvt. Ltd. and third party and equipment
vendors as part of routine maintenance.
Calibration program is carried out for manufacturing and laboratory equipment as per the schedule
established in individual SOPs. A schedule for calibration is required to assure instrumentation
maintains defined acceptance criteria as per Annexure II (Refer F/QAD-006/03). A calibration
program shall detail the following:
 Identifies the instrument for calibration according to criticality.
 Defined calibration intervals for instruments.
 Defines tolerance based on requirements.

Preventive Maintainace:
A preventive maintenance (PM) program is also available to maintain all manufacturing and
packaging equipment and support systems in proper working condition and reduce equipment
malfunctions. A preventive maintenance program is established as per the schedule established in
the SOP: SP/EN/GEN/SOP-001 available for the same in the Engineering department.

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SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
Page No. : 24 of 26

16.0 REVALIDATION/ REQUALIFICATION

Risk Assessment Approach

The risk analysis is carried out to verify the risk of failure of critical GMP, Operation, quality
and System. The critical and non critical areas are identified based on the Risk assessment and
that undergone Requalification/Revalidation.

Requalification of critical systems and equipment is carried out as per change control
requirements after a significant maintenance or modification or relocation has occurred.
Requalification shall be carried out by risk analysis approach and the PQ will be concurrent
batch.
Process revalidation is carried out as per change control requirements after a significant change
to the process or from the recommendations of annual product review or formal assessment of
the existing validation.
Cleaning revalidation is carried out after a significant change to the cleaning procedure or new
product introduced, challenging the established marker.
In case of major changes like major changes in equipment, manufacturing process, system,
change in location of equipment etc., appropriate re-qualification / re-validations shall be
conducted to ensure that the change made does not have adverse effect on quality of the
product.
Requalification of equipment and utility required only in case of
 Major changes in critical component or redesigning of equipment
 Major breakdown
 Relocation of equipment
Process revalidations required only in case of
 Change in manufacturing process
 Change in equipment
 Change in location
 Change in batch size.
 In the case of no any changes in process as described above process consistency can be
reviewed by scientific trend analysis and Annual Product Review.
 Process re-Validation shall be performed after 5 years, if no change is carried in
process.

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006/01
 Document No VMP/14/001
SAMRUDH PACKAGING PVT. LTD., Revision No. 00
G-16/1, MIDC, Tarapur, Boisar,
Thane-401 506. Effective Date
Supersedes None
VALIDATION MASTER PLAN (VMP) Review date
Page No. : 25 of 26

17.0 REVISION CONTROL

This validation master plan will be reviewed every three years, if necessary to update the contents
including policy, shall be revise with proper justification The validation status of the Instruments,
equipment, manufacturing process and cleaning verification shall be updated annually in December
for the next year which shall be part of VMP.

18.0 REFERENCES

18.1 Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-
Sterile Process Validation, Cleaning Validation, PI 006-01, PIC/S.

18.2 Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, ICH.

19.0 ABBREVIATION

URS : User Requirement Specification

FDS : Functional Design Specification
DQ : Design Qualification
IQ : Installation Qualification
OQ : Operational Qualification
PQ : Performance Qualification
SAT : Site Acceptance Test
FAT : Factory Acceptance Test

F/QAD-
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