EHS-005 Hazardous Chemical Substance Management

This procedure describes the requirements for the management of: Approval for proposed new chemical substances. (excluding Contractor activities), Existing chemical substances that are classified as Hazardous Chemical Substances, Material Safety Data Sheets (MSDS).

EHS-010 Environmental, Health and Safety Risk Management

The purpose of this SOP is to: Describe the risk management process of identifying EHS hazards, assessing risk, designing appropriate controls and reviewing the controls, Describe the steps to take and the tool that shall be used to undertake preliminary risk assessments (PRA), Outline the procedure for using the DR system for reporting EHS hazards that cannot be immediately and simply resolved by the observer.

EHS-015 Waste Removal Process

To standardise the types of containers used for handling all types of waste, recycling material and waste from the Manufacturing facilities.

EHS-025 EHS Incident Management Procedure

This procedure defines the requirements for immediate action, investigation, and reporting, corrective action, follow-up and training associated with EHS incidents.

EHS-030 First Aid Procedure

The purpose of this SOP is to formalise the role of the nominated site first aiders, and to provide a clear understanding of the first aiders responsibilities and provide first aiders with information relating to the delivery of first aid.

EHS-035 Blood and Body Fluid Spill Management

This SOP provides information and guidelines for the management of blood and body fluid spills as a result of an accident. Under the relevant Occupational Health and Safety Laws and Regulations for each state, employers have a duty of care to protect their employees in the workplace.

EHS-040 Blood Borne Pathogen Exposure

This SOP provides information and guidelines for the management of exposure to blood borne pathogens in the workplace. Under the relevant Occupational Health and Safety Laws and Regulations for each state, employers have a duty of care to protect their employees in the workplace.

EHS-045 Building Cleaning Procedure

This SOP provides an overview of the procedures used for the contract cleaning and sanitation of the GMP building, Engineering shed and Demountable buildings. The SOP defines the areas and responsibilities for the contract cleaners.

EHS-050 Environmental Management System Plan

This SOP details the Environmental Management System (EMS) that ensures the GMP plant complies with the inhouse Environmental Guidelines and local, state and national government regulatory requirements and has an ongoing improvement plan for environmental performance.

EHS-055 Environmental Aspect Register

This SOP describes the procedure for establishing and updating an Environmental Aspects Register for the GMP site. It outlines steps for identifying, rating and reviewing environmental aspects and impacts.

EHS-060 Fire Protection Impairment Handling

This SOP applies to all buildings on the GMP site. The SOP lists the procedure to record the details and timeframes of the intended fire equipment impairment.

Note: This procedure is a compulsory requirement of our insurance brokers and the Site Fire Protection Guidelines.

EHS-065 Hot Work Permit Procedure

The aim of this SOP is to provide a safe procedure for any hot work that is to be performed at the GMP site facility. This SOP covers all aspects of Hot Work activity at the GMP facility. Hot work refers to any type of work that produces or has the potential to produce, a spark or open flame, including oxy and electric welding.

EHS-070 Hazard Identification and Incident Investigation Reports

The purpose of this document is to define the procedure for identifying, investigating and reporting hazards, near misses and accidents. The outcome is to identify appropriate risk controls and corrective actions to prevent a recurrence of the event.

EHS-075 First Aid Procedure

The purpose of this document is to define the first-aid procedure for the GMP site. The first-aid procedure shall encompass the responsibilities and actions required for first-aid treatment. The first-aid procedure promotes the site philosophy for an early intervention program.

EHS-080 Industrial Hygiene Sampling for Airborne Contaminants

To provide guidance on sampling for airborne contaminants in the workplace and the communication of results to affected staff. Sampling must be performed with a calibrated sampling pump. Calibrations must be performed before and after sampling, for each sampling pump, with the sampling media (filter cassette or sorbent tube) in line.

EHS-085 General Security Procedure for GMP Manufacturing Area

GMP Site Security Team ensures a high level of awareness for security measures implemented for general site access and for the manufacturing building amongst all staff is of critical importance not only for our customers and our integrity as a supplier of prescription medicines but also for continued compliance with the conditions of our licenses to manufacture, import and export Pharmaceutical products.

EHS-090 Occupational Medical Support Procedure for a GMP Site

The purpose of this procedure is to provide all existing and potential colleagues with the information they need to comply with the procedures for preventative occupational medical evaluation and control in compliance with local requirements and EHS guidelines.

EHS-095 Pharmaceuticals Pest Control Procedure

The Pest control procedure is designed to act as a control and preventative maintenance program against insect and rodent infestation to buildings at the GMP site. A pest control program is to be implemented and maintained for the site. The program is designed to protect against the entry and harboring of pests.

EHS-100 Personal Protective Equipments (PPE) Policy for a GMP Manufacturing Site

This policy provides information and guidelines for the supply and purchase of personal protective equipment (PPE). Management is responsible to ensure that appropriate and properly functioning personal protective equipment is provided to employees as necessary to protect them from identified work related hazards. Management should also ensure that employees receive information and training on the proper use and care of PPE.

EHS-105 Environmental Health and Safety Training

The requirements outlines in this procedure are to be completed by all colleagues at the GMP site. Where specifically stated, some of the requirements in this procedure are to be completed by all personnel on site including: Non Manufacturing Operation colleagues & Casual and Temporary Contractors

EHS-110 Laboraotry Spill Response

This SOP provides guidance and instruction on the management of chemical spills in a laboratory environment. This SOP applies only to the spills of liquid and solid chemical spills in a chemistry laboratory environment. Spills of microbiological agents are outside the scope of this SOP.

EHS-115 Process Safety

The purpose of this procedure is to ensure that hazards which have the potential to cause acute catastrophic events, such as accidental chemical releases, fires and explosions are identified, assessed and adequately controlled.

EHS-120 Industrial Hygiene Sampling

This SOP is to provide guidance on a uniform methodology for workplace sampling of personal exposures and engineering performance validation. A sampling strategy should be developed prior to performing sampling. The objective and duration of the survey should be defined in conjunction with line management before sampling commences.

EHS-125 Selection of Personal Protective Equipments (PPE)

This SOP details the selection of Personal Protective Equipment for a GMP site. Assessment of Risks will be assessed in all work areas and for all tasks to identify the requirements for PPE. All personal protective equipment will be worn as directed and will comply with the relevant Australian Standards.

EHS-130 Environmental Health and Safety Risk Assessment Methodology

In a GMP environment a risk-based approach has to be used to evaluate the hazards and controls used to mitigate them. Hence it is essential for Risk assessments to be performed to ensure that all hazards in a plant are identified and are controlled if the risk associated with them is unacceptable. To evaluate and control all risks, Risk Assessment Process has been developed and widely accepted by the industry.