User requirement Specification

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USER REQUIREMENTS

SPECIFICATIONS (URS)

FOR HVAC

(HEATING VENTILATION AIR

CONDITIONING)

UNITED INTERNATIONAL PHARMA COMPANY

LIMITED, VIETNAM,

VSIP 11- SINH DUONG PROVINCE, VIETNAM

UNITED INTERNATIONAL PHARMA COMPANY LIMITED, VIETNAM

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Table of Contents 1.

REVISION INDEX ......................................................................................................................... 3

2.

APPROVAL SiGNATURES .......................................................................................................... 3

3.

OVERVIEW ...................................................................................................................................4

4.

PROCESS DESCRIPTION ........................................................................................................... 5

5.

PRODUCTIVITY REQUIREMENT ................................................................................................ 5

6.

SAFETY REQUIREMENT ............................................................................................................ 6

7.

GMP REQUIREMENTS ................................................................................................................6

8.

PROCESS CONTROL AND ALARMS.........................................................................................1

9.

CLEANING REQUIREMENT ........................................................................................................7

10.

QUALIFICATION REQUIREMENTS ............................................................................................ 7

11.

MATERIAL OF CONSTRUCTION ................................................................................................7

12.

USE OF LUBRICANTS.................................................................................................................7

13.

ENVIRONMENTAL MONITORING ..............................................................................................8

14.

PIC/S ANNEX 11 COMPLIANCE ................................................................................................. 8

15.

DESIRED DOCUMENTS ..............................................................................................................8

16. 17.

TRAINING ..................................................................................................................................... 8

TECHNICAL REQUIREMENTS ................................................................................................... 9

18.

INSPECTION AND TESTING ..................................................................................................... 11

19.

TIMELINES ................................................................................................................................. 12

20.

ABBREVIATION ......................................................................................................................... 12

21.

ANNEXURE LIST ....................................................................................................................... 12



UNITED INTERNATIONAL PHARMA COMPANY liMITED, VIETNAM

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1. Revision Index Revision

Date

Reason for Revision

2. Approval signatures This document Is prepared by SeerPharma (Singapore) Pte Ltd! on behalf of Toyo Vietnam Corporation Ltd, Ho eh! Mlnh City, Vietnam in fUlfilment of the requirements of United International Pharma Company Limited for the Solid and Liquid

non

sterile dose facility to be

built at VSIP II- Blnh Duong Province! Vietnam. Preparation of this document is under the authority of TOYO Project Manager and all relevant parties within TOYO Vietnam Corporation. Before being effective this document shall be checked by TOYO Vietnam Corporation Ltd and approved and authorized by United International Pharma company limited.

United International Pharma Company Limited Project Management United International Pharma Company Limited QA

UNITED INTERNATIONAL PHARMA COMPANY LIMITED, VIETNAM

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