This is a form of process design procedure and forms in accordance with the FDA QSR.

List of Forms
The following forms are included with your purchase.
・MD-QMS-S702 Process Design Procedure
・MD-QMS-F721 Validation Master Plan
・MD-QMS-F722 Validation Plan
・MD-QMS-F723 Process Design Specification
・MD-QMS-F724 QC Process Chart

Table of Contents

Procedure

1 Purpose
2 Scope
3 Definition of Terms
4 Roles and Responsibilities
5 Process Design Control Implementation Procedures
5.1 Process Design Implementation Flow
5.2 Validation Master Plan (VMP)
5.3 Validation Plan (VP)
5.4 Preparation of process design specifications
5.5 Creation of QC process chart
5.6 Preparation of infrastructure and equipment
5.7 Implementation of Qualification of equipment, etc.
5.8 Process Validation (PV)
5.9 Creation of work procedures
6 Change of process
6.1 Process Change Implementation Flow
6.2 Process Change Implementation Procedures
6.2.1 Drafting of process changes
6.2.2 Evaluation of process changes
6.2.3 Implementation of process changes
7 Corrective and preventive action required
8 Records Management
9 Form
10 Reference
11 APPENDICES