Validation Master Plan

SOP No: -VMP-01
Validation Master Plan

Version 2
Effective Date: 01.01.2020 Review Date: 01.12.2022

Supersedes Version: 1 Page: 1 of 27
APPROVALS
Author of the document
Prepared by: Designation:
Signature: Date:
Reviewer of the documents for correctness
Reviewed by: Designation:
Date:
Signature:
Approver for document for use
Approved by: Designation:
Signature: Date:
DISTRIBUTION:
One Master copy shall be prepared.

Master copy will be maintained with Quality Assurance department
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Revision history
S.No. From To Change made
1. Version 4 Version 5  Quality management elements with
respect to GMP principles were
described with reference SOP no.
 Management responsibility defined.
 Revision history added.
 Process flow changed
 Graphical representation of QMS
added
 Quality system documentation
structure is added.
 Reference SOP numbers for all the
elements included
 Quality control as element of QMS is
added
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TABLE OF CONTENTS
S.No. Contents Page Nos.
1. Document History 3
2. Introduction 3
3. Brief Description of Facility 4
4. Validation Policy 4
5. Purpose 4-5
6. Scope 5-6
7. Validation Team 6
8. Responsibilities 7-9
9. Concept of Qualification and Validation 10-11
10. Risk Based Approach 11
11. Validation Program and Supporting Systems 11-13
12. Facility Qualification 13-14
13. Utility Validation 14
14. Equipment Qualification 14-17
15. Analytical Method validation 17-18
16. Supplier Qualification 18
17. Analyst Validation 19
18. Process Validation 19-23
19. Change Control 23-24
20. Equipment cleaning Validation 24-29
21. Calibration 29-30
22. Annual Validation Plan 30-32
23. Review of VMP 32
24. Validation Report 32-34
25. Validation Meeting Update 35
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1. INTRODUCTION
1.1. Validation policy
1.1.1. The validation program at Ohm Pharmaceuticals Lab Private limited is

intended to satisfy current domestic and international regulation, guidelines
and policies for manufacturing of finished drug.
1.1.2. To verify the equipment, system, utiltitie and process are properly designed,
installed and function as intended in a consistent and controlled manner.
1.1.3. “OPL is committed to the concept of validation wherein Suppliers, Processes,
Facilities, Equipment and Equipment Cleaning, Instruments, Control Systems,
Utilities, Analytical methods and QC Analysts shall be put through
appropriate qualification and validation cycles. New products and equipment
shall be validated / qualified before scale-up / use, respectively.”
1.1.4. The VMP may be revised as appropriate to incorporate changes and/or
addition to the facility and/or products.
1.2. Purpose
1.2.1. the objective of this docuent is to outline the validation plan for a GMP site
and to ensure that all necessary structure are in place to facilitate validation.
1.2.2. The validation master plan is designed to provide a planned systematic
framework within which all validation activities will occur.
1.2.3. This document will also ensure that manufacturing facilities complywith the
local applicable GMP regulation and site requirements for validation.
1.3. Scope
1.3.1. To plan all validation activities and to define the key elements of validation
program in the Validation Master Plan.
1.3.2. This plan defines general validation requrements for all direct impact systems
and processes that support manufacture, packaging, testing and distribution
of products manufactured at OPL.
1.3.3. This VMP is a high level document that refers to various supporting
documents. Validation program elements include:
1.3.3.1. Validation/qualification of facilities/utilities/equipment and
corresponding automation/controls
1.3.3.2. Validation of manufacturing processes
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1.3.3.3. Cleaning validation
1.3.3.4. QC laboratory equipments and methods
1.3.3.5. Interval based requalifcation
2. RESPONSIBILITIES
2.1. The Management is responsible for providing the necessary resources including
financial support for proper execution of the Validations as planned.
2.2. While Head of Quality has the overall responsibility to integrate, execute and monitor
the validation process, verify adequacy of the protocols and reports before approval of
each validation or qualification activity.
2.3. The Validation Team has some specific responsibilities as:
2.3.1. Identification of systems, facility, products, processes, methods and support

systems (e.g. HVAC, Water Purification etc.) that need to be validated.
2.3.2. Design Validation Master Plan with “Risk-Based” approach, and its
implementation.
2.3.3. Determining the equipment, instruments, systems, facilities and utilities that
are to be validated.
2.3.4. Preparation of validation and Qualification protocols.
2.3.5. Determining the suitability of the established protocol to qualify a system.
2.3.6. Reviewing each protocol.
2.3.7. Approval of validation protocols by respective functional department heads.
2.3.8. Execution of the validation and qualification protocols with active

participation and supervision where necessary.
2.3.9. Preparation of reports.
2.3.10. Verifying the results of the tests used for the verification of the system as
established by the validation protocols.
2.3.11. Approval of validation results upon verification that each validation
/qualification performed has achieved its pre-determined objectives.
2.3.12. Determining the extent of revalidation necessity in case of changes in a
validated system.
2.3.13. Training and Document Control.
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1. INTRODUCTION
2.4. Responsibility of R & D:
2.4.1. To impart Product-specific Training to Production and QA based on the

“Development Report” to make them understand the process properly.
2.4.2. To discuss the critical controls and “risks factors” with Validation Team
members to help them develop adequate validation protocols which when
used serve the purpose of producing the product that consistently meet the
specifications.
2.4.3. To discuss technical scaling-up aspects with Production and QA to develop
Master Formula Records for a prospective validation process.
2.5. Responsibility of QA:
2.5.1. Generate, review and maintain VMP
2.5.2. Review and approve the sub VMP
2.5.3. Assist in the generation User requirement specification
2.5.4. Review and approve URS document
2.5.5. Assist with the performance of risk assessment
2.5.6. Review and approve risk assessment documents
2.5.7. Review and approve critical aspects list and acceptance criteria as applicable
2.5.8. Review an approve the process control strategy
2.5.9. Review and approve comminsioning and qualification and validation plan
2.5.10. Review and approve Qualification protocols and reports for facilities, utilities,
equipment and processes that have CAs
2.5.11. Review and approve performance qualification protocols and reports
2.5.12. Review and approve process validation and continued verification protocols
and reports
2.5.13. Review and approve Qualification and validation protocol deviations
2.5.14. Approve the use of vendor documents to verifuy functionality of facility,

utility and equipment
2.6. Responsibilities Of Production:
2.6.1. Assists with the performance of risk assessment.

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2.6.2. Assist with the generation of URS
2.6.3. Review and approveURS document
2.6.4. Assist with the generation of sub VMPs
2.6.5. Generate manufacturing SOPs for use during validation
2.6.6. Review and approve IQ, OQ, PQ PV and continued verification protocols and
repors for dfaciliteis, utilities, equipment and processes as applicable.
2.6.7. Prepare schedule in support of IQ, OQ, PQ, PV and continued verification
protocols execution
2.6.8. Ensure equipments/ facilities/materials/personnel availability and technical
support on the operation of the equipment during execution of qualification
and validation activities
2.6.9. Review and approve protocol deviation affecting process equipment
2.6.10. Manage and execute the site’s equipment requalification program
2.7. Responsibilities of Maintenance:
2.7.1. To support Validation team in developing User Requirements Specifications

(URS) and other qualification documents (DQ, IQ, and OQ).
2.7.2. To co-ordinate with suppliers of equipment for ordering, conducting Factory
Acceptance Tests (FAT) where necessary and receiving of equipment.
2.7.3. To verify completeness and appropriateness of the items of the equipment
and documents received from the suppliers, such as Manual, packing list,
designs, drawings, P & ID diagrams, calibration certificates with their
traceability certificates, SOPs, spare part list, standards if any, etc.
2.7.4. To install the received equipment as per the applicable installation protocols
including safety aspects to ensure that the installation is as specified and it is
GMP compliant.
2.7.5. To complete the verification tests such as calibration, safety, earthing, utility
connections, functionality test etc as defined in the protocols to ensure that
the equipment is installed and performing appropriately as defined.
2.7.6. To support the validation team in trials where necessary by active
involvement and support to the validation process from engineering and
maintenance point of view.
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1. INTRODUCTION
2.7.7. To effectively handle trouble shooting.
2.8. Responsibilities of Quality Control:
2.8.1. Assist with the generation of sub VMP
2.8.2. Review and approve the sub VMP
2.8.3. Generate, review, manage execution of and aintain sub VMPs for QC
laboratories
2.8.4. Review and approve ethod validation protocols and reports
2.8.5. Generate, review and approve validation protocols and reports for laboratory
test instrumentation
2.8.6. Review the PQ and PV protocols for analytical and microbiological testing
requirement as applicable.
2.8.7. Perfrom testing requird for validation samples as applicable
2.8.8. Review PQ and PV final reports and verify the accuracy of testing data as
applicable
2.8.9. Review and approve protocol deviations affecting QC test results and
equipment
3. DEFINITION
3.1. Cleaning Validation (CV): Documented evidence that a cleaning process is consistently
and effectively reducing potential product and/or cleaning agent residues to pre-
determined acceptable limits.
3.2. Cleaning Verification: Documented evidence that equipment is cleaned to pre-
determined specifications and may be released for use.
3.3. Clean in Place (CIP): Introduction of cleaning solution and/or water rinses into
equipment that is fixed in place, for purposes of removing potential product and/or
cleaning agent residues
3.4. Clean out of Place (COP): Cleaning of portable or disassembled equipment/parts
involving the use of a cleaning station in a remote designated location.
3.5. Commissioning: A well-planned, documented, and managed engineering approach to
the startup and turnover of facilities, systems, and equipment to the System Owner that
results in a safe and functional environment that meets established design requirements
and stakeholder expectations.
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3.6. Concurrent Validation: Validation of equipment, systems or processes while the
equipment, system or process is in current use for clinical or commercial production
3.7. Critical Aspects (CA): Elements of the systems or equipment, which are critical to the
product quality.
3.8. Critical Process Parameter (CPP): A process parameter whose variability has an impact
on a critical quality attribute and therefore should be monitored or controlled to ensure
the process produces the desired quality (ICH Q8 (R2)).
3.9. Critical Quality Attribute (CQA) A physical, chemical, biological or microbiological
property or characteristic that should be within an appropriate limit, range, or
distribution to ensure the desired product quality (ICH Q8 (R2)).
3.10. Direct Impact Utility : Utility that is used for manufacturing of the product or critical
processes (CIP, SIP) such as Water for Injection, Clean Steam, and Process Gases
3.11. Functional Requirement Specification: A prospective document that builds on the User
Requirement Specification (URS) and provides a basic narrative on what functions the
process and its control system are expected to perform
3.12. Installation Qualification (IQ): Establishing documented evidence that the equipment,
system or software received is correct, is installed properly, in accordance with Pharma
Co., Inc.’s and the manufacturer’s requirements, and has the proper documentation and
support information.
3.13. Matrix approach : A validation approach that uses a philosophy which allows for the
testing of a subset of product batches or “model / placebo products to validate the entire
range of a product /batch, in lieu of testing each product / batch in the matrix. Typical
examples of appropriate applications of this approach include mixing validation and
pooling validation. The bracketing selection is based upon product / batch attributes
such as concentration, solubility, ingredient types, and batch size.
3.14. Operational Qualification (OQ) : Establishing documented evidence that the equipment,
system or software installed, functions in accordance with Pharma Co., Inc.’s and the
manufacturer’s requirements over the intended range of use, or for the intended
applications
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3.15. Performance Qualification (PQ): Establishing documented evidence that equipment or
systems perform in a controlled and reproducible manner in accordance with Pharma
Co., Inc.’s requirements under specific operational parameters, either at the allowable
upper and lower limits of the operation or using worse case conditions compared to
intended operating ranges.
3.16. Process Validation (PV): The collection and evaluation of data, from the process design
stage through commercial production, which establishes scientific evidence that a
process is capable of consistently delivering quality products
3.17. Prospective Validation: Validation of equipment, systems or processes prior to the
release/approval of the equipment, system or process for commercial production or
commercial distribution of product.
3.18. Protocol : A prospective or concurrent test plan with pre-established acceptance
criteria that when executed is intended to produce documented evidence that a system
or system component has been properly tested.
3.19. Quality Attribute: A physical, chemical, or microbiological property of characteristic of
a material that directly or indirectly impacts quality.
3.20. Re-Qualification (Periodic Qualification): Establishing documented evidence that
existing equipment and processes continue to operate in a validated state,
demonstrating continued compliance, effective and reproducibility. This protocol type
is utilized for time based re-qualification activities, such as autoclaves, SIP, ovens, SIP
ovens, lyophilizers, environmental rooms, and cleaning and is not applicable to Change
Control Request driven validation.
3.21. Re-Validation: The validation of a previously validated process typically necessitated by
a change modification to the process.
3.22. Risk Based Approach :An approach that allows basing the project related activities on
risk analysis and placing extra effort on activities that are assessed as posing a higher
risk to the processes and product quality.
3.23. User Requirement Specification (URS): A prospective document that describes what the
equipment or system is supposed to do, thus containing at least a set of criteria or
conditions that have to be met. This can include regulatory, corporate, and process
requirements.
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3.24. Validation: Documented evidence, which provides a high degree of assurance that a
specific process will consistently meet its pre-determined specifications and quality
attributes.
3.25. Validation Master Plan: A prospective document that defines the scope, requirements,
rationale, and protocols necessary for the validation of a new project or process.
3.26. Validation Protocol: A prospective document that provides a detailed test plan used to
qualify/validate equipment, systems, utilities, software or processes.
3.27. Validation Protocol Final Report: A document that provides a detailed summary of the
results from the execution of a Validation Protocol
4. SITE DESCRIPTION
4.1. Facility Overview
4.1.1. Ohm pharmaceuticals Laboratory private limited is located
4.2. Equipment
4.2.1. Equipment used in general manufacturing tablet section area are as follows:
4.2.1.1.
4.2.2. Equipment used in liquid section are as follows:
4.2.2.1.
4.2.3. Equipment used in cephalosporin section
4.2.3.1.
4.2.4. Euipment used in Hormone section
4.3. Description of products and processes
4.3.1. OPL is manufactured generic pharmaceutical formulation namely solid oral

and liquid dosage forms. The manufacturing unit is divided in to general
area, cephalosporin and Hormone section.
4.3.2. In general area, tablet, capsule and liquid dosage forms are manufactured.
The list of the products is provided in appendix A, section 2. The
manufacturing process applied for manufacturing is as follows:
4.3.3. Cephalosporin section, tablet and powder for oral suspension.
4.3.4. Hormone section, only tablet are being manufactured.

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1. INTRODUCTION
4.3.4.1. Tablet are manufactured by direct compression and wet granulation
technique. The list of the product and with the manufacturing
process attached in the appendix A section 2.
4.3.4.2. In section 3.1, the process flow chart is attached.
4.3.4.3. Capsule are manufactured either by direct filling or we granulation
technique. The list of product and the manufacuturing process is
attached in the Appendix A section 2.
4.3.4.4. In section 3.2, the process chart is attached.
4.3.4.5. For liquid manufacturing, the flow chart is attached in section 3.3.
5. EQUIPMENT AND SERVICES TO BE VALIDATED
5.1. Impact assessment
5.1.1. In order to simplify the validation and In order to simplify the validation and
minimise unnecessary qualification activities, an Impact Assessment (IA)
exercise will be carried out, following an approved procedure. This will
encompass all equipment and services installed within the facility. It will
define the validation requirements for equipment and services that are found
to be critical to product quality and risk to patient.
5.1.2. Impact : the impact of equipment on prodcuts shall be categorized as direct,
indirect, safety or no impact.
5.1.2.1. Direct impact: Equipment which is product contact, or which
controls or maintains a critical process parameters or both.
5.1.2.2. Indirect impact: Equipment which is not product contact, but
which has a impact on theperfromance or operation of direct
impact equipment or which is essential to meeting requirements of
GMP compliant process.
5.1.2.3. Safety impact: Equipment which is not product contact, does not
impact on the performance or operation of direct or indirect
impact equipment and whose primary function is a safety
requirement for operators during GMP operation.
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1. INTRODUCTION
5.1.2.4. No impact: equipment which is not product contact, does not
impact impact on the performance or operation of direct or
indirect impact equipment, is not safety equipment and is not
essential to meeting the requirement of GMP comliant process.
5.1.3. It is expected that equipment and services that are deemed non-critical will
be installed, operated and maintained subject to Good Engineering Practice
(GEP).
Data from the IA should be used to provide information for use in the
qualification protocols, such as critical instrument listings and acceptance
criteria.
5.1.4. IA will be considered for any change to established equipment and/or
services in order to help define validation or re-validation requirements.
Validation activities appropriate to the equipment and services may be
considered at IA.
5.1.5. The location of the IA results will be recorded and the data entered in a
validation matrix attached to this VMP in appendix B.
5.2. Risk assessment:
5.2.1. Appropriate risk assessment will be carried out to identify and challenge all
installation, operation, cleaning and maintenance processes.
5.2.2. Each requirement will subsequently be assigned a risk priority of high,
medium or low.
5.3. Validation matrix
5.3.1. Once the impact and risk priority of equipment has been resolved, the
following table should be used to determine the minium extent of
qualification work required.
Highest rated risk priority
Impact High Medium Low
Direct impact IQ, OQ, PQ IQ, OQ, (PQ) IQ, (OQ)
Indirect impact IQ, OQ, (PQ) IQ, (OQ) (IQ)
Safety impact IQ, (OQ) (IQ) Not required
No impact Not possible Not possible Not required
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1. INTRODUCTION
5.3.2. A comprehensive list of equipment, services and processes will be generated
from IA and RA results. Appropriate validation activities from, but not limited
to, the listings in section 6.1 will be entered against all validatable entries to
create a matrix of validation activities.
5.3.3. This matrix will be attached to this VMP in appendix B and updated as
necessary through the life-cycle of the facility.
6. VALIDATION ACTIVITIES
Validation activities will be carried out in accordance with this Validation Master Plan and the
completed documentation will be indexed in the Validation History Files.
6.1. Requirement specification
6.1.1. User requirement specification: An approved statement of the users'

requirements in terms of function, throughput, operatability and applicable
local standards must be obtained for each new item.
6.1.2. Technical specification: An approved document translating the URS into a
specification detailing how the requirements are to be achieved. Together
with the URS, this will provide the objectives and acceptance criteria for the
subsequent validation protocols
6.2. Facility validation
6.2.1. Warehousing
6.2.1.1.Procedure for receiving, identifying, storing and dispositioning

incoming raw material and compounds aswell as the operation of the
warehouse storage area can be found on following SOPs.
6.2.1.1.1. Receiving of RM:
6.2.1.1.2.
6.2.1.2.The room temperature areas are monitor and temperature control.
6.2.2. Facility cleaning validation
6.2.2.1. A facility sanitation program, SOP: PRD- is in place for non product
contact surface.
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6.2.2.2. Room cleaning utilizes at least two disinfectant that are roted daily.
The program was developed to maintain the quality of the
environment , thereby reducing the potential for microbial and
particulate contaminationof theproduct.
6.2.2.3. The program was implemented and is periodically evaluated in
conjunction with the environmental monitoring program.
6.2.2.4. The data collected is used to evaluate on goingeffectiveness of
cleaning procedures.
6.2.2.5. Procedures are in place to evaluate the following criteria:
6.2.2.5.1. Testing the sanitizing agents ability to adequately control
indigenous microbial flora, SOP no.:
6.2.2.5.2. Sanitization schedule
6.2.2.5.3. Rotation of sanitizing agent
6.2.2.5.4. Storage and preparation of sanitizing agent,
6.2.2.5.5. Use of log books

6.2.2.5.6. Inspection of area for cleanliness prior to use
6.2.3. Microbial contamination prevention and control
6.2.3.1. Microbial contamination of the production areas is controlled

through the implementation of standardized cleaning techniques for
critical processing equipment and production areas.
6.2.4. Environmental monitoring
6.2.4.1. An environmental monitoring program was developed and

implemented and ealaute environmental control.
6.2.4.2. Routine monitoring activities are performed to determine total
particle counts, bioburden, differential pressure, etc.
6.3. Utilities Validation
6.3.1. Heating and ventilation and air conditioning system

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6.3.1.1. The purpose of the ai handling system is to control environmental
condition within the production facility. The air handling system
provides clean, conditional air to the controlled environment within
the facility.
6.3.1.2. Conditioning of the air includes temperature, humidity, and
particulate control. Particulate control is accomplished by passing air
through prefilters within the air handling units in terminal HEPA
filters in the room ceilings.
6.3.1.3. Maintenance of differential pressure between adjacent areas and roo
air change rates are accomplished by balancing between adjacent
areas and room air change rtaes are accomplished by balancing the
supply air flow from each air hadler and the supply air flow to each
room or area.
6.3.1.4. Major componenets of AHU servicing the cGMP anufacturing areas
include air handler units, chiller, exhaust fans, distributionductwork
and HEPA filters.
6.3.2. Purified water generation and distribution
6.3.2.1. Purified water IP is used throughout the facility as processing

ingredients and for claning. The system will require commnisioning,
IOQ and PQ testing.
6.3.3. Compressed air
6.3.3.1. Compressed air generated in house.

6.3.3.2. The system will require commissioning, IOQ and PQ testing.
6.4. Equipment qualification
6.4.1. All equipment perfroming a GMP function at the site shall be subjected to
equipment qualification.
6.4.2. Qualification shall be categorized in accordance with the following industry
standard terminology:
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6.4.2.1.
Qualification phase Purpose

Design Verifies the final design against the user,
Qualification functional and or /design specifications to
ensure that all specified design elements hae
been included and that the design meets the
relevant regulatory and statutory
Installation Verifies that the equipment/system/process is
Qualification installed correctly, supplied as specified,
integrated into the site calibration and
maintenance systems and validated for use
Operational Verifies that the equipment/system/purpose
qualification is operating correctly, complaint with
Company name’s functionality requirments
and integrated into the site training system
and QMS.
Perfromance Verifies that the equipment/system/process is
Qualification continuously meeting Company Name’s
performance criteria for routine use
perfroming adequately for routine use in
commercial production.
6.4.2.2. The extent of qualification required for each equipment item shall be
determind by criticalilty and risk assessment described in section 5.2.
6.4.2.3. Equipment shall not be used for GMP purpose until the completion
of the assessment and recommended Qualification. The procedure is
well described in flow chart 1
6.4.2.4. Sub validation master plan, SVMP-01, elaborate details on the
principle followed by OPL for the purpose.
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Qualification Stages Compliance evidence

Input Documents
documnets
Validation master plan: Equipment
Design specification Design review/reports
System factory commissioning

URS
and commissioning report
Risk assessment
Design Documents FAT reports
Design Qualification FAT summary report and

compliance report
FAT protocol
Hardware/ software System factory commissioning
documentation and commissioning report
FAT procedures
Installation Qualification
IQ protocol IQ results
IQ procedures
IQ Summary reports
OQ protocol Operational Qualification OQ results

OQ procedures
SOP’s Summary IQ OQ reports
Training Protocol
Perfromance Qualification PQ results
PQ protocol
PQ procedures Summary IQ OQ reports
SOP’s
Requalification
Ongoing-trends results/review
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6.5. Product validation
6.5.1. The purpose of process validation is to provide documented evidence that the
process and facility can consistently produce product that will satisfy a
predetermined quality standard and comply with the relative Regulatory
standards and is applicable, meet or excedd previous recorded quality levels.
6.5.2. PV requires thre consequetive product bayyches to meet all acceptance criteria
for in process and product testing and will involve enhanced sampling and
testing using validated methods.
6.5.3. Any changes to equipment and /or system critical to product quality will require
PV to be repeated.
6.5.4. New products/[rocesses will be subjected to PV.
6.5.5. The process validation described in SVMP-02. It describes the general

expectations and approaches used uring process and packaging validation
requirement. Additionally, it identifies the plans for documenting, with a high
degree of assurance, that manufacturing processes are capable and
reproducible.
6.5.6. A family grouping approach will be employed wherever practical, based on
process similarity and product type.
6.5.7. Where a worst case product is utilized to represent a product family, the
rationale or characteristics as worst case will be documented in individual
process validation documents.
6.5.8. Thus as a representative product is utilized to reperesent a product family, the
rationale or characteristics as a worst case will be documented in individual
process validation documents. Thus as a representative product is utilized
during validation, the product family is considered validated as a result. There
are …… product families to be validated in OPL. The product families are list in
annex 3.
6.5.9. The validation protocols will also define the batch size, number of batches,
sampling requirements, which may require additional saple points and or
additional tests be peerfromed.
6.6. Packaging validation requirments
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6.6.1. Validation will utilize increased levels of sampling and testing to demonstrate
the packaging process is robust.
6.6.2. A family grouping approach will be employed where practical, based on process
similarity packaging parameters.
6.6.3. Rationale and justification for family selection on risk based approach shall be
followed and will be described inPackaging validation Master plan , SVMP-03.
6.6.4. Where a worst case product is utilized to represent a product family, the
rationale or characteristics as a worst case will be documented in individual
packaging validation documentation. Thus as a representative product is
utilized during validation, the product family is considered validated as a result.
6.6.5. There are …….. product families to be validated. The product familiies are list
in annex 4.
6.6.6. The validation protocols will also define the batch size, number of batches,
sapling requirements which may require additional sample points and or
additional tests be peerfromed.
6.7. Cleaning validation
6.7.1. Cleaning validation will be controlled through a validation master plan, SVMP-
0, will provide documented evidence that a cleaning procedure is effective
inreducing, to predeifined maximum allowable limits, all chemical and
microbiological contamination from an item of equipment or manufacturing
area following processing.
6.7.2. Cleaing procedurs may be validated on a “ worst case”basis, where contaminats,
with scientific justification, will be grouped together and the validation
performed on one or two worst case contaminants.
6.7.3. Wost case contaminants shall be be determined through assessment of toxicity,
solubility, cleanability and justified in cleaning validation plans and or
protocols.
6.7.4. Introduction of new products or other potential contaminants shall be assessed
to consider their impact on the validated state of cleaning procedures.
6.8. Analytical method and laboratory equipment validation
6.8.1. Analytical method validation and the associated laboratory equipment

qualification, which will be the subject of a separate validation plan, SVMP-.
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6.8.2. List of product for which analytical validation is completed is attached in annex
3.
6.8.3. Validation of the analytical methods will be a pre-requisite for any analytical
testing associated with, for example, QC checks and cleaning validation
assessments. It should be demonstrated that the laboratory activities meet the
requirements of GLP
6.9. Computer/software validation
6.9.1. Only be included if any items of equipment have a programmable logic

controller (PLC).
6.9.2. List of the machine with PLC /software is listed in Annex 4.
6.9.3. Validation requirments / approach for each software shall be determined with
risk assessment
6.10. Routine revalidation
6.10.1. Routine revalidation is the schedule retesting and certifying of equipment,
products, procedurs or methods as required by assessment.
6.10.2. OPL perfroms routine revalidation on HVAC, Ovens, incubators, autoclave
stability chamber etc.
6.10.3. The period between revalidation is defined in appendix……
6.10.4. Other items may be considered for rountine revalidation if recommended as a
result of initial validation outcomes.
6.10.5. All other validation and qualifications are performed once and considered
current until assessed otherwise through quality management processes,
including change control, annual review and CAPA.
6.11. Relocated equipment
6.11.1. In case of relocation of the equipments, the equipment relocation procedure
shall be followed which is described by SOP No.: PRD-
6.11.2. The procedure will, as a minimum, control all aspects of the relocation that may
impact upon cGMP.
6.11.3. The procedure will include a model document that can be adapted to suite all
types of equipment.
6.11.4. It should be completed in sufficient detail to ensure that any required
retrospective validation can be completed successfully.
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6.11.5. The evidence of validation and associated documentation that exists for
relocated equipment should be reviewed and the scope of the validation
exercise subsequently defined.
6.11.6. The relocated equipment is deemed to be of direct impact, then it will be
subjected to the impact analysis as decribed in section…….
6.11.7. Where the equipment is deemed to be direct impact, then it will be subject to
the same qualification process as new items.
6.11.8. However, it is recognised that the quantity and/or quality of the supporting
documentation may be limited. In such cases, the criticality of components
should be taken into consideration and steps taken to establish documented
evidence that cGMP requirements are satisfied. The methodology used should be
described in the rationale section of the respective qualification protocols
6.11.9. Typical activities may include
6.11.9.1. Non-destructive testing to establish nature of product contact
materials.
6.11.9.2. Review of process and batch data to provide appropriate OQ and PQ
acceptance criteria.
6.11.9.3. Modification of existing SOPs to reflect use of the equipment in the
new facility, with subsequent testing using the modified SOPs.
6.11.9.4. Review of maintenance records to establish planned maintenance
programme.
6.11.9.5. Re-calibration of critical instruments.
6.11.9.6. Annotated digital photography of equipment to provide pictorial

evidence of component layout and identification
6.11.9.7. Tagging of components.
6.11.9.8. Review of training records to establish re-training requirements
6.11.10. A copy of the equipment re-location procedure and model document will be
placed in Appendix B.
7. ACCEPTANCE CRITERIA
7.1. Acceptance criteria are fundamental component of each validation or qualification
protocol.
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7.2. Each protocol must include acceptance creterail by which the success of failure of the
exercise can be assessed.
7.3. The following guidelines should be implemented when determining acceptance criteria
7.3.1. They must be measurable by means of observation, a treaceable reference

standard instrument or test method
7.3.2. They should demonstrate an appropriate level of reliability and accuracy
7.3.3. They should, where possible and appropriate level of reliability and accuracy
7.3.4. They should, where possible and appropriate, be derived from user and or
vendor defined requirement and specifications
7.3.5. They should, where possible, be derived from industry recognized specification
or targets.
7.3.6. Where it isnot possible to derive from industry recognized specifications or
targets, the suitability of the criteria must be justified in the protocol.
8. VALIDATION SCHEDULE
8.1. The validation schedule for each year shall be planned .
8.2. A schedule of validation activities is provided in Appendix B of this document.
8.3. This schedule is intended to be reviewed at least every six months and updated to reflect
the current status of validation activities on site.
8.4. The schedule lllsit all equipments qualification, process, test methods and computer
system validation required for the site.
8.5. It provides current status, estimated completion dates and explanation for any due work.
9. DOCUMENTATION
9.1. Validation template
9.1.1. Validation template are available to promote consistency of format and

approach to qualification and validation exercise.
9.1.2. Use of the templates is encouraged but not mandatory. Internally prepared
documents using an alternative document format should cover the primary
headings listed in the templates.
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9.1.3. Alternative contents/formats provided by a third party (such as equipment

supplier) are acceptable, provided such protocols and reports are provided by
the manager and meet all applicable requirements.
9.1.4. The following internal templates are available for general validation purposes
9.1.4.1. Validation master plan
9.1.4.2. User requirement specification
9.1.4.3. Equipment validation plan
9.1.4.4. Process validation plan
9.1.4.5. Installation Qualification protocol
9.1.4.6. Operational Qualification protocol
9.1.4.7. Performance Qualification protocol
9.1.4.8. Process validation protocol
9.1.4.9. Validation report
9.2. Document Management

9.2.1. Validation history file
9.2.1.1.
9.2.2. Document control
9.2.2.1. All the validation documents are issued and maintained by Quality
assurance department.
9.2.2.2. Validation documents are initiated by Quality assurance Manager,
who updates the validation register, and issues sequential document
numbers inaccordance with document type.
9.2.2.3. Quality assurance manager determines the appropriate level of
approval for each validation document.
9.2.2.4. Once approved, the sigened hard copy will be stored and makes
copies for execution/ reference as required.
9.2.2.5. If validation documents require revision, the document is updated to
the next revision number and approved by sae level of authority as for
the original document.
9.2.3. Document identification
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9.2.3.1. Example of an identification system below. Text should be modified as

necessary.
9.2.3.2. The following document types are available:
9.2.3.2.1. VMP: Validation master plan

9.2.3.2.2. URS: user requirement specification
9.2.3.2.3. VP: validation plan
9.2.4. Responsibilities and approval of documentation
9.2.4.1. It is recognised that there will be protocols addressing a diverse range

of equipment and systems. Each protocol and its associated report will
be assigned to a relevantly qualified person (the document ‘sponsor’).
Typically the document ‘sponsor’ will be the author of the protocol.
He/she will be responsible for:.
9.2.4.1.1. Ensuring that appropriate protocol/report approvers are
nominated
9.2.4.1.2. Authorising each page of protocol after approval
9.2.4.1.3. Completion of summary report.
9.2.4.1.4. Ensuring that any deviations are progressed (in
conjunction with validation manager).
9.2.4.1.5. Presentation of report for interim and final approvals
9.2.4.2. Checking and approving each completed report test page and
completion of test progress checklist.
9.2.5. Approval of Protocols and Reports
9.2.5.1. The document ‘sponsor’ will ensure that copies of the document are
distributed to all reviewers.
9.2.5.2. Copies of the document will be reviewed simultaneously by all
reviewers. Each reviewer will only comment on items relevant his/her
particular expertise.
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9.2.5.3. After a predefined time, say 5 working days, the comments will be
collated by the sponsor who, within a further predefined time, will
resolve conflicting comments and amend the document. The
document will be re-issued with appropriate revision number for
approval
10. CHANGE CONTROL
10.1. VMP revision
10.1.1. During the course of validation, this validation master plan and its annex may
be subjected to amendment.
10.1.2. Details of ammendments with reason will be recorded in Section…., revision
history, an dthe revised VMP re approved by the signing a revised cover page.
10.1.3. VMP shall be revised once in two year.
10.2. All changes to validated equipment, system, processes and methods are subjected to
change control, in accordance with SOP No. QA-
10.3. For such changes, the effect of a change on validated status must be considered and
documented using from No. QA- change control form.
10.4. It is the responsibility of the change control initiator to ensure that changes either do not
affect the validated status, or that appropriate documentation and testing is included with
the change to ensure that a new validated state can be established.
11. PREVENTIVE MAINTENACE
11.1. It is a requirement of cGMP that effective preventative maintenance procedures are in
place and are followed correctly.
11.2. The validation activities will ensure that these procedures are developed and approved.
The procedures will apply to all equipment and systems that may have a direct or
indirect impact upon product quality
11.3. Maintenance activities will be scheduled such that the minimum requirements for
maintenance are met and will be integrated with production activities.
11.4. Only approved methods and materials will be used during maintenance activities.
11.5. A schedule of all maintenance procedures shall be prepared and maintained to support
the facility during its life cycle. Appropriate procedures will be cross-referenced in the
validation protocols.
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11.6. A list of all maintenance procedures will be indexed or referenced in Appendix B.
Appendix A
S.No. Contents Section
1. cGMP impact assessment
2. Prodcut list
3. Process flow diagram
4. Prodcuy material personal flow diagram
Appendix B
1. Equipment list
2. Validation matrix
3. Master validation history file
Appendix C
1. Validation/project activities relationship chart
2. Validation schedule
3.
4.

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SOP No: -VMP-01