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Table of Contents
Table of Contents....................................................................................................................................................1
1.0 Purpose...............................................................................................................................................................2
2.0 Scope..................................................................................................................................................................2
4.0 References..........................................................................................................................................................2
7.0 Flowcharts..........................................................................................................................................................4
Table Name..............................................................................................................................................................4
Figure Name.............................................................................................................................................................4
Table Name..............................................................................................................................................................4
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].
4.0 References
21 CFR part 820 Quality System Regulation, 820.75
Medical Device Quality Systems Manual, FDA 97.4179
FDA Process Validation Guidance
6.1.1 Components:
Components Source
Component 1 Contract Manufacturer (CM)
Component 2 Purchased from approved vendor
Component 3 CM to manufacture
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.
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].
6.5 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].
7.0 Flowcharts
Table/Figure 1. Table Name
Table/Figure 2. Figure Name
Table/Figure 3. Table Name