Professional Documents
Culture Documents
[Document Number]
[Document Filename]
OTHER
STAMP HERE
Revision
Level
DRAFT
1.00
Revision
Date
DD/MM/Y
Y
DD/MM/Y
Y
DCO/ECO
Number
YY-00000
Description of Revision
Draft
Revision
Author
Author Name
YY-00000
Initial Release
Author Name
[Company Name]
[Company Group, Division, Location]
[Product Name]
Table of Contents
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
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
[Document Filename]
Page 1 of 4
[Company Name]
[Company Group, Division, Location]
[Product Name]
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
3.3
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
6.0
Validation Plan
6.1
Component X Manufacturing
6.1.1
Components
Component 1
Component 2
Component 3
[Document Filename]
Components:
Source
Contract Manufacturer (CM)
Purchased from approved vendor
CM to manufacture
Page 2 of 4
[Company Name]
[Company Group, Division, Location]
[Product Name]
6.1.2
Process
Process 1
Process 2
Process 3
6.2
Qualifications:
Equipment
Arbor Press
Ultrasonic Welder
Heat Sealer
IQ
X
OQ PQ
X
X
X
X
X
Performed By
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]
Page 3 of 4
[Company Name]
[Company Group, Division, Location]
[Product Name]
7.0
Flowcharts
Table/Figure1.
Table/Figure2.
Table/Figure3.
[Document Filename]
TableName
FigureName
TableName
Page 4 of 4