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1、Form Title Supplier EHS Pre Review Questionnaire Form Number F EHS M04 02 Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS M04 Confidential 1 of 13 Confidential Purpose This questionnaire is designed to support the risk review of cu
2、rrent or potential third party suppliers of research and manufacturing services to Pfizer in the following ways Enable Pfizer reviewers to form an initial assessment of risk and plan their on site review Enable Pfizer s third party suppliers to prepare for on site review of their risk management sys
3、tems Instructions for Use for Suppliers This questionnaire contains 3 sections Section 1 Information about your facility Section 2 Risk Management Information Section 3 Documentation for risk review IMPORTANT Please complete a separate questionnaire for each facility that Pfizer has requested inform
4、ation from The questionnaire is designed to be answered with YES NO responses and brief comments or lists of information Please respond YES only if you are able to provide objective evidence during the on site review Please provide the information requested electronically by inserting text editing t
5、his document and emailing it back to the contact named below Your completed response should also contain images for example we request maps site layouts process flow diagrams You may also choose to answer some questions by providing diagrams tables of information process flow diagrams etc Please pro
6、vide the additional information electronically preferably as a pdf file or alternatively as PowerPoint or Visio documents The final page of the questionnaire Section 3 lists the additional information that should be sent with the completed questionnaire It also lists documentation to have available
7、during the on site review Please contact the following Pfizer individual if you need assistance to complete the Questionnaire Name Pfizer Location Email Phone Office Mobile Form Title Supplier EHS Pre Review Questionnaire Form Number F EHS M04 02 Version 01 Date Effective 30OCT07 Supersedes New Form
8、 Applicable to EHS Management of Suppliers Procedure Number EHS M04 Confidential 2 of 13 Confidential Section 1 Information about your facility 1 01 Facility Contact Information Supplier Name Facility Address 1 02 Individual completing form Name Email Job Title Phone Date completed 1 03 Site contact
9、 for EHS review if different from above Name Email Job Title Phone 1 1 Manufacturing and Research services available at facility Drug Product Bulk Manufacturing Drug Product Primary Packaging Drug Product Secondary Packaging Drug Product Formulation Development Chemical Manufacturing Plant Chemical
10、Pilot Plant Biological Manufacturing Plant Biological Pilot Plant Analytical Research Services Medicinal Chemistry Drug Discovery R for example on site or off site capability What is the response time for response from off site e g fire brigade Does the facility have a documented Emergency Response
11、Plan Yes No Does the facility hold periodic practice emergency response sessions and or evacuations Yes No Form Title Supplier EHS Pre Review Questionnaire Form Number F EHS M04 02 Version 01 Date Effective 30OCT07 Supersedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS M0
12、4 Confidential 7 of 13 Confidential 2 7 Business Continuity and Loss Prevention Briefly describe the back up arrangements for the following scenarios Scenario Back up arrangements Power outage Cooling failure HVAC failure Scrubber failure Nitrogen supply failure Raw material supply failure Critical
13、equipment failure Transportation disruption Has the facility been closed due to weather or natural disaster in the last 5 years Yes No If yes please provide details below Is the facility in an area known to be at significant risk from natural disasters eg flooding earthquakes extremes of temperature
14、 heavy snowfall Yes No If yes please provide details of risk and precautions below 2 8 Emissions Controls List 5 most important discharge limits specify substance limit and location eg VOC 10mg m3 incinerator to air Substance Discharge Limit include units Location eg building or vent List typical po
15、llution control equipment in use to prevent or control emissions to air List 5 most important discharge limits specify substance and limit to water Substance Discharge Limit include units Form Title Supplier EHS Pre Review Questionnaire Form Number F EHS M04 02 Version 01 Date Effective 30OCT07 Supe
16、rsedes New Form Applicable to EHS Management of Suppliers Procedure Number EHS M04 Confidential 8 of 13 Confidential Where is waste water from the facility discharged Discharge Yes No Surface water eg watercourse such as stream or river Public sewer Other please give details List typical pollution control equipment in use to prevent or control emissions to water Does the facility routinely exceed discharge limits for air or water Yes No If yes please state any improvement plans Does the facility
