Description
What is the Manufacturing Operations Policy in a Quality Management System?
The four major components in a Quality System Model are:
- Management Responsibilities
- Resource Management
- Manufacturing Operations (this document)
- Evaluation Activities
Q00-0001 Quality Management System Flowchart
Please open, download or print our QMS Flowchart for ease of reference. q00-00-01_qms_flowchart
PURPOSE:
The purpose of the Manufacturing Operations Policy is to provide an overview of our company’s policy from the initial stage of product development to delivery of quality product to satisfy Customers’ needs. The policies develop the path for subsequent procedures (SOP’s), systems and forms to complete the Quality System. The list of policies covers all aspects of research, development, manufacturing, testing and final delivery of products to customers. Pick and choose the statements relevant to your business.
Industry/Regulatory guidance and requirements:
- FDA Guidance for Industry – Quality Systems Approach to Pharmaceutical CGMP Regulations, September 2006, Section IV/C Manufacturing Operations
- ISO 9001 Section 7 Product Realization
- PIC/S Guide to GMP for Medicinal Products, PE009-8, Chapter 5
There are two parts to this document:
- Part 1 (2 pages) – Introduction to Template – describes the rationale of why this policy statement is required; cross reference relevant regulatory clauses.
- Part 2 (6 pages) – the document template and Quality System flowchart.
Who benefits from this document?
- Senior Management and Quality Assurance – who develop quality system policies.
- All other departments who has to employ policies to develop procedures (SOP’s).
Associated documents:
Q00-01 Quality Management System
Q05-0001 Management Responsibilities
Q06-0001 Resources Requirements
Q07-0001 Manufacturing Operations (this document)
Q08-0001 Evaluation Activities
Keywords:
Quality management system manufacturing operations product realisation realization
