An equipment validation protocol for assessing, verifying and documenting the installation and completeness of a built-in, walk-in refrigerator for storing GxP raw materials and finished products at a temperature range of 2 to 8 degrees C. Includes 11 data collection forms for Equipment, Materials in Product Contact, Procurement and Installation Records, Certification Documents, Equipment Manuals, Drawings, Piped Utility Verification, Electrical Utility Verification, Recommended Spare Parts, and Critical and Non-critical Instruments. The IQ Report, and OQ Protocol & Report are available as 11-0042-IQR-1.0, 11-0042-OQP-1.0, and 11-0042-OQR-1.0.
Document identifier
DOXPUB 11-0042-IQP-1.0
Title
2 to 8C Cold Room Installation Qualification Protocol
DOXPUB Category
IQP - Installation Qualification Protocal
Publication date
2004-08-01
International Relationship
Price |
320 vnd |