Pre-Audit Document Request List

更新时间:2023-07-22 00:57:17 阅读：评论：0

Pharmaceutical Supply Chain Initiative (PSCI)

PRE-AUDIT DOCUMENT REQUEST LIST

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	Available	Not Available	Not Applicable
1 General Management Systems
Organization chart
Site drawings showing: ❒property borders, ❒tanks, ❒detailed building layouts ❒hazardous chemicals, solvents, oils and wastes storage, ❒stacks and vents ❒buried rvices (pipes, drains, wers) ❒buried tanks ❒sumps, pits, oil parators ❒lagoons and any points of discharge to local watercours ❒on site waste disposal areas (ud and abandoned and disud)
Site HSE policies and programs
Management of change documentation
Inspection and follow-up records
Compliance lf-asssment reports
HSE training records
Incident and Emergency Respon Plans.
Roles and responsibilities matrix
Previous audit reports
Reports of regulatory agency inspections and enforcement actions
Regulatory agency correspondence
Copies of previous social and HSE audits/review reports
Details and outcome of complaints if any (plus correspondence).
Government Inspection reports, e.g. sanitation, fire safety, structural safety, environmental compliance, etc
before2 ENVIRONMENT – General
Correspondence with authorities relating to any environmental violations and pollution incidents (air, water, effluent, wastes, odor and noi).	leadto
Emission Reduction Plan

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Waste reduction plan
Spill, incident and upt reports
Documented procedures and operating manuals relating to environmental matters (e.g. emergency respon, spill containment, waste handling and disposal).
3 AIR EMISSIONS
All current air permits
Air monitoring data for the past 36 months
2013江苏高考英语Air emissions inventory
Air emissions reports submitted to regulatory agencies
Copies of any violation notices received in the past three years
Copies of any federal/national, state/provincial and/or local emissions standards
michael怎么读Chlorofluorocarbon compounds (CFC) equipment maintenance records
Air pollution abatement equipment maintenance records
4 WATER SUPPLY, STORM WATER, AND WASTEWATER
Wastewater discharge permits
Wastewater discharge inventory
Wastewater wer drawings
Wastewater treatment permits
Wastewater discharge monitoring data/reports for flow and permit parameters for last 36 months
Wastewater treatment plant maintenance records and as-built drawings
Site’s water balance

Water abstraction permits
Storm water discharge permits
Water supply drawings
Storm water wer drawings
Copies of violation notices received in the past three years
Well construction diagrams for on-site water supply or groundwater monitoring wells
Water quality analys from water supply or groundwater monitoring wells for the past 36 months
List of active pharmaceutical ingredients (API) being discharge in the waste water and a list of known Predicted No Effects Concentration Levels for the APIs.
Copies of waste water risk asssment studies detailing the Predicted Exposure Concentration of API discharges and potential impact evaluations
5 WASTE MANAGEMENT
Waste inventory
Waste transport and disposal documentation (manifests, receipts, invoices)
Waste generation, storage, treatment or disposal permits or registrations
Disposal records of halons, refrigerants, PCBs and asbestos including costs
Any waste-related reports to regulatory authorities
Copies of violation notices received in the past three years
Waste storage area Inspection records
Waste analys and classification determinations
6 HAZARDOUS MATERIALS CONTROL AND REPORTING
Tank inventory (number, location , age, construction, volume, content, alarms, vent pumps and cathode protection fitted to bulk tanks

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Documented procedures for filling and unloading bulk storage tanks
Procedures and records for tank maintenance - integrity testing (bulk tanks and pipe work) etc
Hazardous material inventory
Tank and containment inspection records
Tank integrity and tightness test records
Drum management plan
Spill respon plans
Hazardous materials reports (e.g., Tier II, Form R, NPRI)
Copies of spill and relea notifications or reports and remediationcertified
Hazard communication training records
7 ASBESTOS, PCBS AND OZONE-DEPLETING SUBSTANCES
Asbestos survey
Inventory of asbestos-containing materials
Records of asbestos abatement and disposal
Polychlorinated Biphenyl (PCB)-containing equipment inventory
PCB test results from analysis on electrical equipment
Pesticide inventory
8 HEALTH & SAFETY DOCUMENTATION
Summary of occupational injuries and illness for the past 3 years			leed
Permit to Work program

Lockout/tagout program
Hazard communication program
Respiratory protection program
Industrial hygiene monitoring results
Personal protective equipment program
Hot Work Program
Noi, chemical, or indoor air quality monitoring data
Hearing Conrvation Program and Test Records
Bloodborne Pathogens Program and Records
Confined Space Entry Program and Permits
Fire protection plan
Piping & Instrumentation Diagrams
Hazard Area Classification
Basis of Safety
Health and Safety training records
Radioactive material inventory and licens
Safety Inspection Reports
Safety Manual
Records of baline physical examinations and periodic examinations.
Medical Surveillance program

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