Site Validation Master Plan

<Document Tracking#> Rev<#>

<Company Name>

<Company Name>

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Site Validation Master Plan
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<Company Name>

LOCATION: <Location>

Site Validation Master Plan

DOCUMENT NO. <Document Tracking#>

Revision: <#>

Date: <Date>

The signatures below indicate agreement with the responsibilities defined within this

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<Company Name>

Site Validation Master Plan

APPROVAL SIGNATURES / DATES

Author: Date:

Quality Assurance: Date:

Site Leader: Date:

Operations/Manufacturing: Date

Engineering: Date

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TABLE OF CONTENTS
1.0 INTRODUCTION AND SCOPE ....................................................................................................... 5
2.0 FACILITIES/UTILITIES/EQUIPMENT DESCRIPTION ................................................................... 7
3.0 SUPPORTING QUALITY SYSTEM ............................................................................................... 11
4.0 KEY DEFINITIONS ........................................................................................................................ 12
5.0 RESPONSIBILITIES ...................................................................................................................... 17
6.0 VALIDATION APPROACH............................................................................................................ 18
6.1 VALIDATION STRATEGY ................................................................................................................ 18
6.2 IMPACT AND CRITICALITY ASSESSMENT ......................................................................................... 19
6.3 VALIDATION ACTIVITIES ................................................................................................................ 19
7.0 VALIDATION METHODOLOGY AND REQUIREMENTS ........................................................... 20
8.0 REVALIDATION ............................................................................................................................ 20
9.0 DECOMMISSIONING .................................................................................................................... 21
10.0 VALIDATION ACTIVITIES/PLANS AND MILESTONES .............................................................. 22
11.0 RESOURCES ................................................................................................................................ 23
12.0 REFERENCES ............................................................................................................................... 23
13.0 REVISION HISTORY ..................................................................................................................... 24
14.0 ATTACHMENT INDEX .................................................................................................................. 25

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1.0 INTRODUCTION AND SCOPE

This Site Validation Master Plan (SVMP) describes <Company>, <location>

facility’s overall approach and intentions for establishing validation activities. It
will provide an overview of the <Company>, <location> validation approach and
planning to complete validations in accordance with GMP regulations. The Site
Validation Master Plan is intended to be prescriptive and dynamic, providing
guidance and direction for studies and projects, and maintaining a level of
flexibility to allow for changes in processes and requirements. Although a live
document, the intent is not to update the Site Validation Master Plan for each
project which requires qualification and therefore will not be inclusive of all
validations. On an annual basis this document will be fully updated with
applicable site and validation information/details/ schedules, then reissued and
approved.

<Company> Quality is responsible for ensuring validation and change control

activities are executed and documented in compliance with internal <Company>
procedures and cGMPs. Each process and product change, including computer
system changes will be assessed to determine the level of testing and/or
validation required, the decision documented, and approved by defined functional
areas.

This Site Validation Master Plan applies to the facilities, equipment, and
processes that are subject to cGMPs and within the responsibility of <Company>.
This includes, but is not limited to, an assessment of the following areas:
facilities, equipment, processes, software systems and revalidation activities.
The validation activities in this plan shall be prospective, unless otherwise
determined by the quality group. All Validations shall follow the same general
validation approach.

<Company> Quality is responsible for ensuring validation and change control

activities are executed and documented in compliance with the following internal
procedures:
 SOP XXX ‘Change Management’

In addition, to the following global documents and business specific

regulations/standards:
 Code of Federal Regulations Part 820, “Quality System Regulation”
 Code of Federal Regulations Part 210 and 211, “cGMP in

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Manufacturing, Processing, Packing, or Holding of Drugs and

Finished Pharmaceuticals’
 ISO 9001:2008, “Quality Management System Requirements”

The type of equipment, systems, processes that are within the scope of the
SVMP are:
 USP Purified Water System
 EO, Gamma and Steam Sterilization
 Compressed Air
 HVAC
 Aseptic processing
 Process Validation
 Software Systems
 Direct Impact equipment
The utilities, equipment and processes that are outside the scope of validation activities
and will not be covered within this SVMP are:
 Systems and equipment with an indirect impact or no impact on
product SISPQ
 Security System
 All non-GMP utilities, systems, equipment and processes

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2.0 FACILITIES/UTILITIES/EQUIPMENT DESCRIPTION

Plant Description

Sample for illustrative purposes……

The <Company> facility in <location> is approximately 220,000 square feet in size and
manufactures both medical device and pharmaceutical products. Operations began in
1985.
The facility has X filling and packaging lines. Most device and pharmaceutical products
are aseptically filled in 6 filling rooms under Class A.
There are separate areas for warehousing, weighing, compounding, filling, utilities,
product storage, accessories and testing. The facility is designed and constructed to
comply with current Good Manufacturing Practices.

Product
Sample….
Product Name Identifier Class
XYZ Medical Device
ABC OTC

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Process Flow
Sample for illustrative purposes……

Receiving
 Receive chemicals, sterilized components at the warehouse truck dock.
 Stage for Quality Assurance (QA) inspection
 QA inspects and test materials in QA Laboratory and approves in the inventory
control and maintenance system that controls the order entry to product release. QA
labels material.
 Locate material to warehouse rack.
 Deliver chemical from the warehouse to the chemical storage area.
 Deliver labels to label room for inventory replenishment.

Production
 Once approved by the receiving area, chemicals are transferred for batch weighing.
 Chemicals are then transported to compounding
 The chemicals are then reweighed prior to the compounding of the batch.
 Pipe batch to fill rooms.
 Deliver sterilized plastics to fill rooms
 Deliver labels from label room to packaging line.
 Deliver remaining packaging materials to packaging line.
 Clear the line and verify components.
 Fill and package product on lines.
 Perform in-process inspection, final inspection, and sampling.
 Product travels from the lines to palletizer.

Review
Product travels from palletizer to the Distribution Center to await testing and release.
Perform batch review; chemical and microbiological testing.

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Utilities- GSF
Purified Water
City water from surface lakes enters the plant through a 6” carbon steel pipe and is
reduced to 80 psi for use.
The city water is used for: (1) Potable water for domestic use, and (2) Utility water for
the manufacturing process. This overview addresses water usage for the manufacturing
process.
All the city water distribution within the plant is in copper pipe.
The water passes through a mixed bed deionized water system which consists of the
following components:
 The water passes through a UV light for reduction of the bioburden level.
 After the UV light the water passes through a sand filter, which removes large
particulate matter.
 Water passes through a carbon filter to remove chlorine and dissolved organics.
 Water passes through 10-micron cotton wound prefilters to remove smaller
particulate matter.
 Water passes through a mixed bed resin tank to remove ions from the water.
 The deionized water is stored in two (2) 10,000-gallon storage tanks.
 DI water is used for the manufacture of purified water and steam.
 Deionized water is pumped through 304 stainless steel piping to Finn Aqua multiple
effect purified water stills. There are four (4) water stills. These stills produce
purified water.
 From the stills, the purified water flows by gravity to two (2) 8,000-gallon 316L
stainless steel storage tanks and is stored at a minimum of 85 degrees Celsius.
 The storage tanks have a continuous pumping loop with 316L stainless steel piping
that supplies water to a 13,800-gallon 316L stainless steel storage tank and is stored
at a minimum of 85 degrees Celsius.
 The 13,800-gallon 316L stainless steel storage tank has a continuous pumping loop
that travels throughout the building in 316L stainless piping for use in product
manufacture.
 This loop also supplies purified water to a 5,000-gallon 316L stainless storage tank
and is stored at a minimum of 85 degrees Celsius.
 This 5000-gallon tank has a continuous pumping loop that supplies water throughout
the building in 316L stainless steel piping for use in cleaning applications.
 This loop utilized for cleaning has point of use heat exchangers located at the
various drops that cools the temperature of the water to approximately 30 degrees
Celsius for use.

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Pure Steam
Pure steam is produced by evaporation of deionized water by a pure steam generator
located in the utility area. Pure steam is utilized to pressurize the headspace of tanks
and provides steam inject to reduce foam during manufacturing. The pure steam
generation process is as follows.

City water from surface lakes enters the plant through a 6” carbon steel pipe and is
reduced to 80 psi for use. City water is used for domestic potable water and utility water
for the manufacturing process. All city water travels in copper pipe.

City water passes through a mixed bed deionized water system (described under water
system). The deionized water is pumped through 304 stainless steel piping to Finn
Aqua pure steam generators. Two steam generators operate as master/slave units.

Pure steam 316L stainless steel distribution piping consists of a 45-psi header and a 30-
psi header. The 45-psi header is primarily used as chamber steam for steam autoclaves
and SIP for FFS. The 30-psi header is primarily used for SIP of product piping and mix
tank headspace injection.

Plant Steam
Plant steam is produced by the evaporation of city water by boilers located in the utility
area. Plant steam is utilized for non-product contact applications. Plant steam is supplied
to water stills, steam generator, mix tank jackets, and office HVAC.

Compressed Air
Pressurized air is produced in an oil-free compressor located in the utility area.
Compressed air is utilized for the air supply to product manufacturing processes in the
compounding and aseptic processing areas. The compressed air generation process is
as follows.
 Ambient air from inside the utility room is drawn into an oil free screw air
compressors.
 The air passes through a filter prior to the air compressor to filter out dust to prevent
damage to the air compressor.
 The air compressor produces compressed air at 125 psi.
 Air is collected in an air receiver tank.
 Air travels through a series of 5-micron filters for the removal of liquid water, oil, and
solid contamination.
 Air travels through a refrigerated air dryer for moisture removal.
 Air travels through a final 5-micron filter for the removal of liquid water, oil, and solid
contamination.

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 Air is piped through a 3” copper header throughout the facility for use. The air
pressure header is maintained at 100-125 psi.
 Air passes through sterilizing filters and pressure reducers at the point of use (sterile
applications).

HVAC
The heating, ventilation, and air conditioning system provides air to pressurize the
aseptic processing area. The air is filtered by passing through prefilters, bag filters, and
ceiling mounted HEPA filters. Air is returned through low sidewall returns to the air
handler. Air handlers utilize steam and chilled water for temperature and humidity
control.

3.0 SUPPORTING QUALITY SYSTEM

Quality systems and programs that affect validation include Preventative
Maintenance, Metrology (Calibration), Training, Cleaning and Sanitation, Change
Control and Non-Conformances.

3.1 Preventative Maintenance (PM) and Calibration

3.1.1 A calibration procedure SOP xxxx ‘Calibration Program’ is in-place

for the GMP equipment or instruments that require calibration.
Equipment being validated must be calibrated prior to conducting
OQ studies, where applicable. Preventative Maintenance
procedure SOP xxx ‘Preventative Maintenance Program’ is in place
for the unscheduled and scheduled maintenance for the building
and equipment at <location>. The maintenance schedule and spare
parts lists will be documented and in-place by the completion of the
validation for any processing and testing equipment which affect
product quality, that is considered serviceable. Non-serviceable
equipment will be monitored on an ongoing basis to assure proper
operation.

3.2 Training

3.2.1 Training is conducted according to the training program outlined in

SOP xxx ‘Employee Training’ to ensure all employees have the
training and experience to perform their assigned functions.

3.3 Cleaning and Sanitation

3.3.1 The sanitation and housekeeping is managed per SOP xxx

‘General Housekeeping’ and SOP xxx ‘Insect and Rodent Control’.

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These SOPs ensure housekeeping and pest control are properly

implemented and executed for each operation. Personnel health &
hygiene are managed in SOP xxx.

3.4 Change Control

3.4.1 The Change Control program monitors, evaluates, approves, and

documents changes to systems, processes, procedures,
equipment, and facility. The requirements for Change Control are
defined in the Change Management System ‘xxxx’. Impact of the
change on the product will be assessed and the impact on
validation will be determined.

3.5 Non Conformance/CAPA

3.5.1 The non-conformance process monitors, evaluates, approves, and

documents non-conformances that have occurred to systems,
processes, procedures, equipment, and facility. The requirements
for non-conformances are defined in the Non-Conformance
Management System ‘xxx’. Non-Conformances may require CAPA
per the requirements ‘xxx’.

4.0 KEY DEFINITIONS

For the purposes of this document, the following acronyms have been defined:

Abbreviation/Acronym Definition
Acceptance Criteria The acceptable requirement level for qualification
essential for accepting or rejecting that particular
facet of the equipment/process.

Aseptic Process Microbiological simulation of an aseptic process by

Simulation the use of growth media processed in a manner
similar to the processing of the product using the
same product contact surfaces of equipment,
container/closure systems, critical environments and
process manipulations. This simulation mimics the
manufacturing processes to assess the potential of a
product unit to become contaminated during actual
operations.
Calibration The process by which an instrument of known
accuracy or a certified standard is used to detect,
report or eliminate any variations in the accuracy of
the item being tested.

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Abbreviation/Acronym Definition

Change Control A formal monitoring program where qualified

representatives of appropriate disciplines review
actual or proposed changes that might affect the
validated status of a system and take preventative or
corrective action to ensure that the system remains in
a validated state of control.
CIP: Clean In Place
Cleaning Validation Establishing documented evidence, which provides a
reasonable degree of assurance that a specific
cleaning procedure consistently cleans a particular
piece of equipment or container to a specified,
predetermined level of cleanliness
Critical to Quality Equipment, system or process attributes directly
related to non tolerable, critical, major and minor
acceptable quality levels.
Critical Process The process variables that are considered vital to the
Parameters quality of the product being manufactured.
Installation Installation Qualification (IQ) establishes documented
Qualification: evidence that all key aspects of the manufacture and
installation of a system, utility or piece of equipment
conform to design specifications and manufacturers
recommendations.
Facilities: Facilities are areas, rooms, spaces, such as staging,
reject material stores, shipping/receiving, process
areas, etc.
Final Report (FR): A document, when required, summarizes the
completed process validation program. Approval of
the Final Report closes the validation program.
GAMP: Good Automated Manufacturing Practices.
GMP Good Manufacturing Process
Methods Validation Process of demonstrating with documented evidence
that analytical procedures are suitable for their
intended use.
Operational Operational Qualification (OQ) establishes
Qualification documented evidence that a system, utility or piece of
equipment performs as intended by design and the
manufacture throughout all anticipated operating
ranges.
Operating Range A range of values for a given operating parameter
that lies on or below a specific maximum value and
above a specified minimum value.
PM Preventative Maintenance

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Abbreviation/Acronym Definition
Processes For the purposes of this Master Plan, a Process is
defined as a series of steps or actions controlled by a
written procedure that are used to accomplish a
desired result.
Process Owner: Department or individuals with knowledge and
responsible for the process. This role includes
process users and are most likely the authors of
process procedures.
Process Parameters: Process parameters are properties or features that
are assigned values which are used as control points
or operation limits to assure the product meets the
specifications and quality attributes. Examples
include temperature and level set points or limits,
timer settings, air pressures etc.
Process Variable: Process variables are properties or features of a
process that are not controlled or that change in time.
Process variables do not effect product specification
or quality attributes. Examples include distillation
column pressures, storage tank levels, etc.
Performance The documented verification that the facilities, utilities
Qualification and equipment as connected together can perform
effectively and reproducibly based on the approved
process and product specification.
Protocol: A protocol is a written procedure that clearly and
accurately defines the steps, equipment, methods
and acceptance criteria to be used in conducting a
validation study.
Qualification: The process of examining and documenting a
process. Qualification encompasses both Verification
and Validation as documented in (as applicable) the
Product OQ, PQ, and the Final Report.
Quality Assurance: The activity of proving that all information necessary
to determine product suitability for the intended use
by gathering, evaluating and approving evidence. The
Quality Assurance Department executes this function.
Quality Attributes: Quality attributes are the properties a utilities or a
systems product. This could be elements such as;
finished pack appearance, tablet appearance, sealing
effectiveness.
Quality Control: The activity of measuring in-process and final product
parameters to compare with standards to assure that
they meet predetermined limits. The Quality
Assurance Department executes this function.

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Abbreviation/Acronym Definition
Requalification A repeat of some or all of the process validation to
provide an assurance that the process continues to
perform as intended.
Revalidation A repeat of some or all of the process validation to as
a result of a process failure, adverse trend, major
process change, etc.
SIP Steam In Place
SISPQ Safety, Integrity, Strength, Purity and Quality
Specifications: A document that defined and sets acceptance criteria
for a given element with quantitatively measured
values. Specifications are used to specify raw
materials, in-process materials, final products,
equipment and systems.
Sterilization Validation Validation of sterilization processes demonstrating
that the process will consistently yield a product free
of viable organisms with a specified probability and
with process variables falling within predetermined
limits.
Support Department Department or individuals support the process
owners. This support may include technical and/or
analytical.
Standard Operating A written procedure followed by trained operators to
Procedure (SOP) perform a step or steps of an operation, process, or
other function in the production of a finished packed
product or a finished drug product.
SVMP Site Validation Master Plan
System For the purposes of this master plan, system is
defined as a combination of equipment and
instrumentation connected via piping or wiring
designed to achieve one purpose.
Validation The Food and Drug Administration regards validation
as ‘Establishing documented evidence that a specific
process/system or piece of equipment will
consistently produce a product meeting its pre-
determined specifications and quality attributes with a
high degree of assurance.’
Validation Scope The scope of the validation protocol or program
defines the boundaries of the equipment, process or
system to be addressed by a particular document or
validation program.
Validation Strategy A validation plan which defines what needs to be
validated and how validation needs will be met for a
given project. The strategy also provides a roadmap

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Abbreviation/Acronym Definition
to follow ensuring the requirements are defined and
agreed upon up-front and that all requirements are
met prior to implementation or launch.
User Requirement Specifies what the end user requires the equipment
Specification or system to do.
Worst Case A set of conditions including the upper and lower
processing limits or circumstances which pose the
greatest chance of process or product failure during
operation. Such conditions do not necessarily include
process or product failure.

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5.0 RESPONSIBILITIES
Validation activities at <location> are generally conducted using a team approach
with varying degrees of responsibilities for each department involved. The team
involved may include the following:
Functional Area
Author/Validation
Quality Assurance
Operations/Manufacturing
Engineering
Process Excellence
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Responsibilities
 Develops SVMP Document by
collecting information, schedules,
etc. for current and future validation
activities
 Updates SVMP as required
 Responsible for validation execution
is conducted in accordance with
<company> and local policy and
authors final reports
 Reviews and approves SVMP
Ensures that the SVMP is written in
accordance with Global, plant and
regulatory requirements
 Ensures that qualifications/
validations conducted at the site are
performed in accordance with
global and local policies and
procedures.
 Ensures qualification product is
quarantined.
 Reviews and approves SVMP
 Assists in scheduling the
qualification/validation activities
 Provides trained operators/
resources when appropriate to
support the qualification/ validation
 Reviews and approves SVMP
 Provides technical explanation and
support of the change to the
process. Provides the applicable
data required to support the
change.
 Provides technical support of new
products or changes to products.
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Functional Area Responsibilities

Analytical/Chemistry,
Microbiology Laboratories
IT
Environmental, Health and
Safety
Provides the applicable data
required to support the change and
analyzing the results
 Provides technical feedback to the
impact on Environmental Controls
such as air, water, and surface.
 Provides resources as required to
perform applicable testing to
support qualification/validation
activities
 Reviews and approves SVMP, as
applicable
 Advises the validation group/author
on impact to software systems
 Assists and/or executes validation
projects, as applicable
 Ensures that all changes and new
installations of equipment or utilities
comply with internal <company>
requirements, ISO 14001:1996

6.0 VALIDATION APPROACH

6.1 VALIDATION STRATEGY
Validation activities should be initiated by a global change control form
and/or current local procedure SOP xxx ‘Change Management’.
For large validation projects, a validation strategy document will be used
to define the specific qualification/validation requirements. If it is
determined that a strategy document is not required, all activities of the
project will be detailed within the protocol Strategy/Rationale section.
Based on site procedure SOP xxx ‘Change Management’ a cross
functional group may perform a risk assessment by evaluating change
control submission form.
The group determines the validation required along with the qualification
activities required based on the information presented.
Requirements for performing Risk Management activities are defined in
xxx or equivalent risk assessment tools, which will be performed/updated
as part of the validation activities.

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When Equipment/Systems/Utilities include Software or Software Systems,

an SQA Specialist or equivalent will be notified for consultation on the
project. The discussion/decision will include, but is not limited to: type of
test to be performed, how the testing will be executed and who is
responsible for executing the testing.

Software Qualifications shall follow the <Company> Life Cycle System

Requirements. This system includes the process requirements for
developing, implementing, maintaining, and retiring software and software
systems. Progression through the SDLC shall be in accordance with the
SDLC model appropriate for the project.

All qualifications will be assigned a unique tracking number defined by

SOP xxx.

6.2 IMPACT AND CRITICALITY ASSESSMENT

All equipment and systems that have been designated as critical to
product SISPQ will be validated. The criticality and system impact of all
equipment and systems are outlined in Appendix 2. Failure of critical
components may have a direct impact on product quality, whereas failure
of non-critical components will have an indirect or no impact on product
quality. Systems and equipment with an indirect impact or no impact on
product SISPQ fall outside of the scope of this Site Validation Master Plan.

A system is considered critical if any of the following criteria is applicable:

 The system has the potential to directly affect product SISPQ

 The system preserves product status
 The system produces data that is used to accept or reject product

Appendix 3 - Validation Matrix, identifies systems and equipment that

have been designated as critical, along with the status of qualification and
required validation activities to be performed.

6.3 VALIDATION ACTIVITIES

All validation activities, including the initiation and execution of Equipment
and System Installation Qualification, Operational Qualification,
Performance Qualification and Process Validation are detailed within the
Validation System as outlined in SOP xxx .

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7.0 VALIDATION METHODOLOGY AND REQUIREMENTS

All validation activities are conducted according to written protocols. Validation
protocols contain or reference all information needed to complete the validation
study; and each protocol addresses the validation or qualification of a specific
equipment or system and follows the standard protocol format.

8.0 REVALIDATION
Re-validation will be considered on a case by case basis. The following items
must be considered:
 Significant process shifts,
 Numerous minor process changes,
 A significant major process change,
 Significant equipment downtime,
 Relocation of equipment,
 If a significant amount of time (i.e., 3-5 years) has elapsed since the
last validation was conducted (for those processes or equipment that
may deteriorate over time) or
 When a validation fails.
Each of the situations identified above will require a Validation Review identified
locally per xxx .
Requalification/Performance verification is required on an annual basis for
 Steam Sterilizers
 Steam In Place processes
 Gamma Irradiation
 EO Process

Requalification: Criteria for requalification evaluation

 Type/Number of system changes
 Type/Number of system deviations
 Type/Number of related process/batch deviations
 System Calibration history
 System PM history
 Type/Number of procedural changes

System owners will review all cGMP direct impact equipment/systems for
changes, upgrades, problems, modification and preventive maintenance.

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SOP xxx defines the frequency and criteria for requalification and
reassessments of cGMP equipment and systems.

Aseptic or sterile operating equipment and systems will require a yearly

re-qualification or validation.

PQ re-validation can be a single run but with appropriate and intensified

testing and/or sampling

9.0 DECOMMISSIONING
Decommissioning for the retirement or disposal of qualified equipment or
systems, which are no longer used or required for manufacture, must be properly
documented.

All decommissioning activities need to be documented within a Decommissioning

close out report. A punch list of activities to consider includes:
 Change Control has been initiated to begin decommissioning
process
 Protocol has been written and approved to detail the
decommissioning activities
 Cleaning is thorough and documented
 Adherence to appropriate regulatory guidelines
 History files and related compliance documentation updated or
archived
 Regulatory submission or changes have been made
 All open change controls and or nonconformances related to the
decommissioned equipment/system have been addressed and
closed
 All environmental and local regulations are complied with
 All safety issues have been addressed
 Decommissioning close out report has been issues
 Equipment/system is appropriately maintain/stored
 Appropriately maintained in a storage area, as applicable
 SOPs for the operation of the storage area/facility

For Equipment/ Systems which are returned/re activated, the following

must be considered:
 Equipment/System to be re qualified
 EHS will have to give approval
 Regulatory filings or listings to be addressed
 All SOPs and other applicable documentation reactivate,
revised and approved

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10.0 VALIDATION ACTIVITIES/PLANS AND MILESTONES

The following is a comprehensive list of validation activities known at the time of

this plan for execution in 2013 and will be used to provide guidance for the
planning and resource allocation processes. The list is driven from the key
projects <company> management has identified for 2013. This list is not
intended to be all inclusive; however it may be updated based on the number of
modifications throughout the year. On an annual basis this document will be fully
updated with applicable site and validation information/ details/ schedules, then
reissued and approved.

In addition, the project milestones have been established in Appendix 1– Project

Milestones for 2013

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11.0 RESOURCES
Personnel responsible for performing validation activities, whether internal or
external, are required to have the appropriate background and experience
necessary to permit them to fulfill the required functions per local and global
procedures or policies. Personnel performing validation activities shall have
undergone training on validation procedures and documentation requirements,
and the training shall be documented in the local plant training system.
<Company> Plant Quality is responsible for ensuring personnel performing
validation activities have completed training to validation procedures. The
validation lead is responsible for ensuring that all resources participating in
validation activities have been trained to the approved protocol(s).

12.0 REFERENCES

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Site Validation Master Plan
<Document Tracking#> Rev<#>
<Company Name>

13.0 REVISION HISTORY

Revision
Date Submitted By Comments
Number




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Site Validation Master Plan
<Document Tracking#> Rev<#>
<Company Name>

14.0 ATTACHMENT INDEX

Attachment
Description
Number
1 2013 Validation Activities / Status
2 Impact and Criticality Assessment
3 Validation Matrix

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 Attachment 1: 2013 Validation Activities

(Periodic Review, Requalifications, Projects, Remediation)

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 Attachment 1: 2013 Validation Activities

Requalification
Equip/System Requirement Expected Timing Core Resources Status
(function lead in
italics)
nd
Gamma- Source Reload Annual Reload 2 Quarter Operations,
Validation
nd
Production Steam 2 per year 2 Quarter Operations,
Sterilizers Microbiology
Validation
QA Steam Sterilizer#2B 1 Gravity cycle /year 2nd Quarter Microbiology Post poned under planned
1 Liquid cycle /year Gravity Validation deviation 1234

3rd Quarter
Liquid
Line Steam In Place 1 per year 2nd Quarter Operations,
Microbiology,
Validation
Gamma- Dose Audits Quarterly Audit of components, Each Quarter Operations,
accessories and garments Microbiology
Validation

EtO 1 per year 4th Quarter Operations,

Microbiology
Validation
Aseptic Simulation Line 1 1st Quarter Operations,
Line 2 2nd Quarter Microbiology
Line 3 1st Quarter Validation
Line 4 2nd Quarter

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Equip/System
Classified Areas (A, C and D)
Microbiology Hoods
Water / Clean Steam
Compressed Air
HVAC Critical Areas
Manual cleaning processes
Vision Inspection
Cartoner Inspection
FFS
Portable Mix Tanks
Stationary Mix Tanks
Portable Sterilizers
Automated Cleaning
Processes
Packaging Equipment
Laboratory Instrumentation
Warehouse Storage
Page 28 of 34
Attachment 1: 2013 Validation Activities
Periodic Review Schedule- 2013
Expected Timing Core Resources (function lead in italics)
3rd/4th Quarter Validation, Microbiology, Operations
3rd/4th Quarter Validation, Microbiology, Operations
3rd/4th Quarter Validation, Microbiology, Operations
3rd/4th Quarter Validation, Microbiology, Operations
3rd/4th Quarter Validation, Microbiology, Operations
3rd/4th Quarter Validation, Microbiology, Chemistry, Operations
3rd/4th Quarter Validation, Operations
3rd/4th Quarter Validation, Operations
3rd/4th Quarter Validation, Operations
3rd/4th Quarter Validation, Operations
3rd/4th Quarter Validation, Microbiology, Operations
3rd/4th Quarter Validation, Operations
4th Quarter Validation, Microbiology, Chemistry, Operations
3rd/4th Quarter Validation, Operations
3rd/4th Quarter Validation, Microbiology, Chemistry
3rd Quarter Validation, Warehouse Logistics
 Attachment 1: 2013 Validation Activities

Validation Remediation
Equip/System Description Expected Timing Core Resources (function
lead in italics)
Labware Washer Unvalidated labware washer Complete Validation, Chemistry
Area 12 Air Handlers Air Handlers in Class A have not 4th Quarter 2013 Validation, Project
been validated Engineering, Receiving,
Microbiology
Raw Material Manual cleaning in receiving area 3rd/4th Quarter 2013 Validation, Chemistry,
Sampling Tools (multi use sampling tools) are not Microbiology, Receiving
validated
Packaging Equipment Heat Tunnels are not validated 4th Quarter 2013 Validation, Operations
Filling Equipment Manual cleaning in filling area 2nd Quarter 2013 Validation, Chemistry,
Product Contact Parts (product contact parts) not validated Microbiology, Operations

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Site Validation Master Plan
<Document Tracking#> Rev<#>
<Company Name>

Attachment 2: Impact and Criticality Assessment

(Reference Reason Codes)

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 Site Validation Master Plan
Type
Compounding Area
Stationary Mix Tank
Portable Mix Tanks
Compounding Process
Monitoring System
Filling Area
Bottle Hopper
Filler
Capper
Plugger
Sterilization Datalogger
Packaging
Bottle Inspection Device
<Document Tracking#> Rev<#>
<Company Name>
Rationale and
Criteria System Impact
Description of Function
(Indirect/Direct)
(Reason Code#)
 Compounds product formulations 1,3,5,6 Direct
 Heat Sterilizes product formulations
 Compounds various phases of product formulations 1,6 Direct
 Heat Sterilizes product formulations
 Monitors process pressure 5 Direct
 Aseptically holds and transports bottles to filler 2 Direct
 Aseptically delivers a predetermined volume of solution 1 Direct
 Aseptically places a closure onto a bottle 2 Direct
 Aseptically places a closure onto a bottle 2 Direct
 Ensures and documents the steam sterilization steam temperature 5,6 Direct
and time at the fill line use point
 Inspects filled units for minimum volume 6 Direct
 Inspects for cap presence
 Inspects for cap placement
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Site Validation Master Plan
<Document Tracking#> Rev<#>
<Company Name>

Appendix 3 - Validation Matrix

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 Site Validation Master Plan
<Document Tracking#> Rev<#>
<Company Name>

Compounding Area
Type Identification Description Validation Validation
Reference Completion Date
Stationary Mix Tanks Tank 20 1700L Val 1998 2008
Tank 15 2100L Val 2000 2011
Tanks 12 and 14 19000L Val 0005 1985
Tank 10 40,000L Val 0106 1998
Portable Mix Tanks PMT 12-1234 270L Val 0900 2005
Digital Control System Compounding Process ABC Val 2234 2010
Monitoring System
(last upgrade)
Steam Sterilizer 4 DEF Val 909 2005

5 DEF Val 910 2005

Filling
Type Identification Description Validation Validation
Reference Completion Date
Aseptic Filling Systems Line A GHI (Filler) Val 1999 2008
(Bottle Hopper, Capper, Line J (not in service) GHI (Filler) Val 2001 2011
Plugger, Filler)
Line D JKL (Filler) Val 0006 1985
Line E JKL (Filler) Val 0107 1998
Line F MNO (Filler) Val 0901 2005

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 Site Validation Master Plan
<Document Tracking#> Rev<#>
<Company Name>

Packaging
Type Identification Description Validation Validation
Reference Completion Date
Bottle Labeler w/ Vision Line 1 Vision Inc Val 0010 1985
Inspection System
Line 2A
Line 4
Line 5
Line 6
Line 7
Cartoner Line A Cartoner Co Val 0012 1986
Line J (not in service) Cartoner Co Val 0013 1985
Line D Boxes Inc Val 2225 2010
Line E Boxes Inc Val 2226 2010

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