PLANREFERENCE OUTLINE

Contamination Control Strategy (CCS) Framework

Updated Nov 2024EU GMP Annex 1 · ISO 14644-1 · USP <1116>

[ DOCUMENT CONTENTS ]

The full section structure of the CCS framework — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control

› Document Information› Approval Signatures› Revision History› Distribution List

1Purpose and Scope

› 1.1 Purpose› 1.2 Scope

2Regulatory and Standards Framework

3Contamination Control Philosophy

› 3.1 Contamination Types› 3.2 Hierarchy of Controls

4Facility and Engineering Controls

› 4.1 HVAC and Air Handling› 4.2 Pressure Cascade Design› 4.3 Cleanroom Classification› 4.4 Material and Personnel Flow

5Procedural Controls

› 5.1 Gowning and Degowning› 5.2 Cleaning and Disinfection› 5.3 Materials Management› 5.4 Change Control

6Environmental Monitoring Programme

› 6.1 Sampling Locations› 6.2 Alert and Action Levels› 6.3 Monitoring Frequency› 6.4 Exceedance Management

7Contamination Risk Register

8Supplier and Material Controls

9Training and Qualification

10Trending, Review and CAPA Integration

› 10.1 EM Data Trending› 10.2 Review Triggers› 10.3 CAPA Integration

11Related SOPs and Reference Documents

AAppendix A — Contamination Control Risk Matrix

BAppendix B — Regulatory Cross-Reference Table

CAppendix C — Monitoring Location Map