QUALITY MANUAL (QM)

What is Quality manual

The quality manual is a statement of the Company’s Quality Policy and Quality Objectives of the organization.

Which Guideline follow for preparation of QM

Eudralex Volume 4 (Chapter – 1 Pharmaceuticals Quality System), ICH Q8, Q9 and Q10, Schedule M.

Contents of QM

Introduction, Scope, Basics of Quality Management System

Quality Policy, Quality Objective Quality Risk Management Policy

Company Profile, Organization, Regulatory Basics

Documentation For The Quality Management System

Document Structure Production of Quality Management System

Accompanying Quality Management System

Design/Project Management, Qualification and Validation

Maintenance, Health requirements, Personnel hygiene requirements, including clothing

Complaints, Product Recall, Customer Management

Product Documentation, Labeling And Packaging Control

Product Quality Review, References

Review Period

Every Two Years

Storage Period

Perpetual