QM: 4.2 Documentation Requirements (4.2.1 General)

Introduction

This section provides the general outline the structure of documentation system maintained in an organization.

Types of documents in a pharmaceutical company can be:

• Quality Policy (a part of Quality Manual)
• Quality Objectives (Part of Quality manual, annexure to QM, or a separate document)
• Quality Manual
• Plans (Quality Plans, Test and Inspection Plans, Product Realization and Control Plan, Service realization and control plans,  Risk assessment and Mitigation plans etc)
• Procedures (Quality Procedures, Operating Procedures, Product Realization Procedures)
• QA/Control Procedures and Quality Specifications
• Design Standards (DSs)
• Manufacturing specifications
• Labeling and Packaging specifications
• Work Instructions and Forms
• Standards and Codes
• Technical Reference Materials
• Device Master Record/Master formulae Record
• Engineering documents, including drawings, specifications, procedures and other document defining products and system
• Customer engineering documents
• Records (Manufacturing and Processing records, Records of Internal Review, Records of Product realization, equipment operation, logbooks etc)
• Reports (Inspection and test report, audit reports, CAPA)

4.2	DOCUMENTATION REQUIREMENTS
4.2.1	General

4.2 Documentation requirements

4.2.1 General:

Company’s Quality Management System documentation includes:

• Documented statement of Quality Policy
• Documented statement of Quality Objectives
• Quality Manual
• Procedures and Work Instructions (Required for implementation, maintenance and control of QMS (including 6 mandatory procedures by ISO Standard, Procedures required for effective planning, operation and control of processes)
• Records (Records required by ISO Standard and those generated through planning, operation and control of processes)
• Standards and other technical reference materials
• Any documents specified by national or regional regulations

or

As classified by ISO template Quality Manual

• Level 1: Policies – key system objectives
• Level 2: Quality Manual – approach & responsibility
• Level 3: Procedures – methods (Who, What, Where & When)
• Level 4: Work Instructions – description of processes (How)
• Level 5: Forms, Data & Records – evidence of conformance

The term "document" is also used to name the information of a similar character stored in a computer. (Paper based documentation system and electronic documentation system shall be demarcated and explained in this section). The company ensures that personnel have access to QMS documentation and are aware of relevant procedures.

Subcontractors are provided access to applicable documents through document control distribution.