Appendix Files_ALL

EXHIBIT C1 – SCOPE OF WORK Warehouse and Walk-In Cold Rooms (Revised SOP 000109480)

Applicable Sites: Applicable Areas:

1.0 Objective This procedure describes the Cleaning Requirements for the cGMP warehouse (Warehouse Room 1400 and associated 2-8 °C Cold Room 1409, -20°C Freezer Room 1410 and Shipping and Receiving Room 1401 at CLIENT EXAMPLE. 2.0 Scope This procedure applies to the cGMP Warehouse. 3.0 Definitions and Abbreviations

Term / Abbreviation

Definition

IPA

Isopropyl Alcohol Lock Out, Tag Out

LOTO

PPE WFI

Personal Protective Equipment

Water for Injection

4.0 4.1

Requirements

Environmental, Health, and Safety • Personnel performing cleaning must wear appropriate PPE, including at a minimum goggles or safety glasses. • Refer to EHS and Safety Data Sheets as needed for safe operations and handling including: Glycol, refrigerant, and all other chemicals introduced.

4.2

Material and Equipment/Tools • 70% IPA Pre-Saturated Wipes, Sterile • Bleach • WFI • 70% IPA • Sterile Low Lint Wipes

4.3

General Requirements N/A

4