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[Company Name]

[Company Group, Division, Location]

Product Name: [Product Name]


Document Title: Validation Master Plan
Document Number: [Document Number]
Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY


STAMP HERE

OTHER
STAMP HERE

Revision Revision DCO/ECO Revision


Level Date Number Description of Revision Author
DRAFT DD/MM/Y YY-00000 Draft Author Name
Y
1.00 DD/MM/Y YY-00000 Initial Release Author Name
Y

COMPANY PROPRIETARY AND CONFIDENTIAL


[Company Name] Validation Master Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

Table of Contents

Table of Contents....................................................................................................................................................1

Tables and Figures..................................................................................................................................................1

1.0 Purpose...............................................................................................................................................................2

2.0 Scope..................................................................................................................................................................2

3.0 Definition Of Terms...........................................................................................................................................2


3.1 Contract Manufacturer............................................................................................................................2
3.2 Installation Qualification (IQ).................................................................................................................2
3.3 Operational Qualification (OQ)..............................................................................................................2
3.4 Performance Qualification......................................................................................................................2

4.0 References..........................................................................................................................................................2

5.0 Responsibilities and Requirements....................................................................................................................2

6.0 Validation Plan...................................................................................................................................................2


6.1 Component X Manufacturing.................................................................................................................2
6.1.1 Components:..............................................................................................................................2
6.1.2 Qualifications:...........................................................................................................................3
6.2 Instruments/Equipment ..........................................................................................................................3
6.2.1 Off-the-shelf..............................................................................................................................3
6.2.2 Custom......................................................................................................................................3
6.3 Software 3
6.4 Facilities Systems....................................................................................................................................3
6.5 Suppliers 3
6.6 Validation Testing and Standards for Product Handling, Storage and Distribution...............................3
6.7 Product/System Validation.....................................................................................................................3

7.0 Flowcharts..........................................................................................................................................................4

Tables and Figures

Table Name..............................................................................................................................................................4

Figure Name.............................................................................................................................................................4

Table Name..............................................................................................................................................................4

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 4


[Company Name] Validation Master Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

1.0 Purpose
The purpose of this document is to specify [Product Name] manufacturing process validation plans to
ensure that the product meets its specifications and intended use.

2.0 Scope
This document applies to all facilities, equipment and processes that are subject to the Food and Drug
Administration Quality System Regulations. The scope of this document includes but is not limited to
facilities, manufacturing equipment, analytical equipment, calibration, test equipment, computer related
systems, processes and test methods used in the manufacture of [Product Name].

3.0 Definition Of Terms

3.1 Contract Manufacturer


A company that provides outsourced process development, manufacturing and packaging services
for a fee.

3.2 Installation Qualification (IQ)


A method for establishing documented evidence in protocol and report form that process
equipment and associated system installations adhere to design criteria and that the
recommendations of the manufacturer are considered.

3.3 Operational Qualification (OQ)


A method for establishing documented evidence in protocol and report form that operational
parameters of equipment result in product that meets all predetermined specifications.

3.4 Performance Qualification


A method for establishing documented evidence in protocol and report form that a process will
consistently produce acceptable product under normal operating conditions.

4.0 References
21 CFR part 820 Quality System Regulation, 820.75
Medical Device Quality Systems Manual, FDA 97.4179
FDA Process Validation Guidance

5.0 Responsibilities and Requirements


The Quality and Engineering departments are responsible for the administration and management of the
validation program, and serve as primary resources to determine validation requirements, and to write,
review, and approve validation protocols.

6.0 Validation Plan

6.1 Component X Manufacturing

6.1.1 Components:
Components Source
Component 1 Contract Manufacturer (CM)
Component 2 Purchased from approved vendor
Component 3 CM to manufacture

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 2 of 4


[Company Name] Validation Master Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

6.1.2 Qualifications:
Process Equipment IQ OQ PQ Performed By
Process 1 Arbor Press X
Process 2 Ultrasonic Welder X X
Process 3 Heat Sealer X X X

6.2 Instruments/Equipment

6.2.1 Off-the-shelf
Individual performance validations will not be conducted on off-the-shelf instruments, however a
performance qualification will be performed on the entire test system.

[Insert off-the-shelf equipment list here]

6.2.2 Custom
[Insert custom made equipment list here].

6.3 Software
Software design and development will satisfy the requirements of [Insert requirements].
It will be validated [describe validation plans].

6.4 Facilities Systems


[Insert facilities requirements here].

6.5 Suppliers
Suppliers will be qualified and managed in accordance with [Company Name] Supplier Control
standard operating procedures.

6.6 Validation Testing and Standards for Product Handling, Storage and Distribution
[Insert validation plans for packaging, shipping and handling].

6.7 Product/System Validation


[Insert product validation plans].

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 3 of 4


[Company Name] Validation Master Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

7.0 Flowcharts
Table/Figure 1. Table Name
Table/Figure 2. Figure Name
Table/Figure 3. Table Name

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 4 of 4