This is a set of templates on process validation in a form that is in line with FDA QSR.
The FDA places the highest priority on the quality of the finished medical device.
Process validation is one of the important items to ensure quality.
List of Forms
The following forms are included with your purchase.
・MD-QMS-K75 Process Validation Provision
・MD-QMS-S7501 Process Validation Procedure
・MD-QMS-F7501 PV Implementation Plan
・MD-QMS-F7502 PV Implementation Report
・MD-QMS-S707 Equipment Qualification Procedure
・MD-QMS-F771 Qualification plan for equipment
・MD-QMS-F772 DQ Implementation Results
・MD-QMS-F773 IQ OQ Implementation Results
・MD-QMS-F774 PQ Implementation Results
・MD-QMS-S709 Production Process Risk Management Procedure
・MD-QMS-F791 FMEA Sheet
Table of Contents
Process Validation Provision
1 Objective.
2 scope (of a document)
3 Definition of Terms
4 outline
5 Process Validation
5.1 general
5.2 Process Validation (In Vitro Diagnostics)
5.3 Software Validation
6 Conduct risk assessment
7 Preparation of process validation plan
8 Qualification Assessment (Qualification)
8.1 Design Qualification (DQ)
8.2 Equipment Installation Qualification (IQ)
8.3 Operational Qualification (OQ)
8.4 Performance Qualification (PQ)
9 Process Validation
9.1 implementation standard
9.2 Determination of process validation
9.3 Types of Process Validation
9.3.1 Predictive Validation
9.3.2 concurrent validation
9.3.3 Cleaning Validation
10 revaluation
10.1 re-qualification
11 reprocess validation
11.1 Criteria for re-process validation
11.2 Periodic re-process validation
12 sample size
13 Record keeping
14 reference
15 by-laws
Process Validation Procedure
1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Perform process validation
5.1 Planning for Process Validation
5.2 Perform process validation
5.3 reprocess validation
5.4 Periodic re-process validation
6 Record keeping
7 form
8 reference
9 by-laws
Equipment Qualification Procedure
1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Perform equipment qualification
5.1 Conduct FMEA
5.2 Qualification Plan Preparation
5.3 DQ (Design-Qualification)
5.4 IQ (Installation Qualification) and OQ (Operational Qualification)
5.5 PQ (Performance Qualification Qualification)
5.6 requalification
6 Record keeping
7 form
8 reference
9 by-laws