瑞士诺华制药为世界制药行业领导者,2013年排名全球第一。本文为北京诺华制药洁净空调操作规程,通过GMP、FDA、TGA审计,供同行借鉴参考学习。

HVAC System Operation Procedure

空调系统操作程序

Replaces No.: SOP-000309 version 02 Reason for Change: 1.

Integration of all HVAC Units of EPCP in operation.

1

Regulatory Basis and Reference Documents

Novartis Quality Manual: Module N6.2: Cleanliness Zoning

IGs N6.2.2: Cleanliness Zoning Policy for The Manufacture of Non-Sterile Drug

Products and the Respective Drug Substance

BNP SOPs:

SOP-000066: Filter Replacement for HVAC Installation

SOP-000192: Room Monitoring Cleanliness Zoning parameters P Pa, T℃, RH % SOP-000213: Operation and Cleaning for Sampling Cabin (R907) in Warehouse SOP-000217: Preventive Maintenance for HVAC Units

SOP-000328: General Operating Procedures in case of HVAC Shut Down SOP-000390: Cleanliness Zoning

SOP-000475 Room Condition Monitoring in case of RMS fails (none availability) NB. Upon approval of the RMS SOP these SOPs will be referenced to this SOP.

2 Purpose

To specify the general sequence of HVAC system start up and shut down. To specify the general instructions on how to operate the HVAC systems.

3

No. 1.1 2.1 2.2 2.3 3.0 4.0 5.0 6.0 8.0

Scope

This SOP is valid for all the following production related HVAC systems in Beijing Novartis Pharma. Ltd, ChangPing.

Function Production area Capsule filling Emugel filling Emugel processing Packaging N/A Lockers QC Alu-Alu

Servicing areas Dispensing A-308, Day storage Room A-310, Blending Room A-313, Intermediate Storage A-504, Granulation Room A-506, Compressing Rooms A-508.1, Compressing ante-room A-510, Capsule filling room A-Zone 2

508.2, Coating Room A-514, Coating drying room A-516, Corridors 300 and 500 etc.

Encapsulating A-511, Printing A-509 and locker 507 Zone 2 Cream/Ointments Filling A-505 and Personnel Lockers 505.1, 505.2,

Zone 2

505.3, 501.1

Cream/Ointments Processing A-503 and locker 501, Storage room 503.1 Secondary packaging A-405,Air locker 405.1 etc. N/A

Offices and Production Lockers QC Laboratories

Alu-Alu Blister Packing A-302, Compressing Room A-304

Zone 2 Zone 2 Zone 3 Zone 2 Zone 4 Zone 2