冻干机风险分析RA

GMP Risk Assessment Procedure
The following summarizes the procedure for this risk assessment.
1.1. System Description
The system analyzed within this document is a BOC ETPS (Edwards TianLi Pharmaceutical Systems) Lyofast 10 industrial freeze dryer. This equipment is designed to lyophilize
liquid pharmaceutical products in sterile environment. The system consists of a chamber, a condenser, product shelves and functional sub-systems. For design details refer to
the system Functional Specification (FD0738-FS), Software Design Specification (FD0738-SDS) and Hardware Design Specification (FD0738-HDS).
1.2. Identification of Potential Failure Modes with Possible cGMP Impact
Each device associated with this equipment is evaluated in failure mode against each operational phase of the equipment to determine if in the failure mode the device will affect
the quality of the product. If it is determined that a device failure will affect the product, a severity level is evaluated as follows:
A. Low – There is no risk to product and the production process may not be halted.
B. Medium – There may be a risk to the product through a combination of events and the production process will be halted.
C. High – The product will be lost.
1.3. Identification of Potential Effects of Failure Mode
Each device (referenced by Tag, Device Name & Function) which is identified as affecting the product in failure mode is reviewed in detail against the following:
A. Expected Result: What is the expected result to the operation of the equipment in the event of the failure of the device.
B. Severity Of Failure Mode: The severity rating assesses the seriousness of the potential failure mode to the product and the production process.
C. Current Design Safeguards: Current design safeguards are identified to see if the product and process are adequately protected in the event of a device failure.
D. Recommended Additional Risk Mitigation: If there is insufficient protection for the product or process in the event of a device failure additional risk mitigation

英文版的吗

xinyuncao514 发表于 2013-11-7 10:39
英文版的吗

是的

网上都有啊，可惜是英文的