Legislation and Standards

Size: px
Start display at page:

Download "Legislation and Standards"

Transcription

1 Chapter 4 Legislation and Standards By the end of this chapter, you will be able to: l Name the key references and guidance standards in aseptic preparation l Define the term audit l Explain the differences between licensed and unlicensed units l Explain what SOPs are and give some examples l List other standards and legislation used or followed in your workplace Introduction In this chapter we are going to look at the legislation and standards that control how we work in aseptic production units to maintain the highest quality standards. Key References Prompted by the thalidomide tragedy in the 1960s, the Medicines Act 1968 was brought in to govern the manufacture and supply of medicines in the UK. The underlying principle of the Medicines Act is that, subject to specified exemptions, no medicinal product may be placed on the market for sale, supply or offer for sale without an appropriate marketing authorisation (also sometimes called a Product Licence). The aim of the Act is to assure the quality, safety and effectiveness of medicines and, to a certain extent, place liability on the marketing authorisation holder for adverse effects arising from the use of their product. Aseptic production units work to the standards laid down in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (see current version). This is also commonly known as the Orange Guide, and its content as Good Manufacturing Practice (GMP). The standards in the Orange Guide are compiled by the Medicines Health products Regulatory Agency (MHRA). Chapter 4: Legislation and Standards 1

2 Aseptic Processing Edited by Alison Beaney on behalf of the NHS Pharmaceutical Quality Assurance Committee, Quality Assurance of Aseptic Preparation Services (Yellow Guide) gives guidance on all aspects of the principles of Good Manufacturing Practice (GMP). All aseptic preparation units work to the standards set out in Aseptic dispensing for NHS Patients (Farwell Report). This was produced in 1995 by John Farwell and provides guidance to NHS aseptic units on standards of aseptic preparation. Farwell (1995) sets out specific policies for aseptic activity and highlights the need for a quality system. These are observed in all units and should include: l Detailed, approved operational procedures to cover all facets of the activity l Defined responsibilities, competencies, training and performance of staff involved in the activity l Control of all materials, including containers, devices and packaging, used in the processes. l Appropriate provision and use of special clothing (for operator and product protection) l Provision, maintenance and correct performance of facilities and equipment, including disposables, for the whole range of activities carried out l Consistent approach to product presentation including labelling l Full documentation of systems and processes and other product-related issues, e.g., customer complaints l Validation of all procedures l Comprehensive quality assurance with independent approval l Reference to other legislative requirements, where necessary, eg, COSHH, Ionising Radiation Regulations, etc Licensed Units Some hospital manufacturing units hold a Specials Licence granted by the MHRA. This allows the unit to manufacture pharmaceutical products without a product licence or marketing authorisation that are required by industry. Licensed units can: l manufacture products and sell to external customers; l assign extended expiry dates to products, provided they are supported by stability data. Unlicensed Units Aseptic preparation units can operate under an exemption from Section 10 of the Medicines Act, when dispensing directly to named patients. i.e. without a specials licence, providing the following conditions are met: l preparation is done by or under the supervision of a pharmacist who takes full responsibility for the quality of the product; l the preparation uses closed systems (i.e. not open to the atmosphere) l licensed sterile medicinal products are used as ingredients or the ingredients are manufactured sterile in licensed facilities; l products will be allocated a shelf life of no more than one week and the shelf life should be supported by stability data l all activities should be in accordance with defined NHS guidelines. 2 Chapter 4: Legislation and Standards

3 Chapter 4 Legislation and Standards Some differences between aseptic preparations under Section 10 Exemption, compared to specials manufacturing licence Section 10 Exemption Maximum 7-day expiry Prepared or directly supervised by Pharmacist Must only be prepared against a legal prescription Final check and release may be done together Release may be done by any locally approved Pharmacist Standards must comply with local and QA regional audit Audits Audits are a process of checks, carried out to ensure that Good Manufacturing Practice standards, such as those laid down in the Orange Guide (see current version), Farwell(1995) and PICS (2008) are upheld. Licensed units are subject to inspection by MHRA GMP inspectors every 2 years. All units, both licensed and unlicensed, must carry out regular internal and external audits. l Internal audits should be carried out by staff who are part of the management organisational structure of the department. Audits may be carried out internally according to an audit calendar with action taken to rectify any non-conformances as required. l External audits should be carried out by staff who are not managerially accountable and are independent of any service provision to the unit. External audits should be carried out at a suitable frequency, at least every 18 months, as required by EL(97)52. Specials Manufacturing Licence Expiry limited to stability evidence Prepared by suitably trained person following approved procedures Can be prepared for stock Final check and release MUST be done by separate people Release may only be done by person registered by MHRA, e.g. Pharmacist or Qualified Person (QP) Standards must comply with MHRA inspection which is much more stringent For Self Inspection, a self audit programme should be established that monitors the implementation and compliance with the written guidelines for quality assurance and good manufacturing practice, and that considers the type and complexity of operations performed, which includes: l an annual self audit plan with records; l evidence that adequate corrective actions are undertaken. Self audits should be conducted in an independent and detailed way by designated competent people. Records of all auditing should be made, with action plans compiled, completed and re-assessed. Chapter 4: Legislation and Standards 3

4 Aseptic Processing Standard Operating Procedures (SOPs) These are instructions and information on how to carry out a wide range of operations in your unit. SOPs are devised to ensure uniformity in all processes and that the best way of carrying out a task is determined and reproduced consistently. SOPs should cover all areas within the preparation process. These instructions should be followed at all times with no deviation (unless under exceptional circumstances where the deviation is approved by a supervisor, has been evaluated and documented and is known to be safe and does not affect the quality of the product in any way). No operator should rely on word of mouth to transfer information and there should be no individual interpretation of information. If there is doubt about a procedure or policy, the line manager should be contacted and an explanation given. Some examples are: l Management of procedures l Error recording l Cleaning and disinfecting l Fridge validation l Test failure l Unusual event recording l Maintenance and repairs l COSHH and Health & Safety l Capacity and planning l Entry and exit from facilities l Documentation l Environmental monitoring l Labels and labelling l Use of equipment l Waste l Product preparation checks and release l Product sampling and testing l Process validation l Operation of the Unit l Staff training and testing l Request processing l Action to be taken in case of system failure l Controlled drugs l Storage and distribution of products l Spillage l Product complaints and recalls l Assembly and transfer of ingredients l Laundry Other General Legislation & Standards Health and Safety at Work Act The Health and Safety at Work Act 1974 identifies the Health and Safety responsibilities of both the employer and the employees. Take care of your own safety and that of others who may be affected by what you do your acts or omissions. The purpose of the Health and Safety at Work Act etc is to provide the legal framework to promote, stimulate and encourage high standards of health and safety at work. Further Reading You should read your department Health and Safety procedures and be aware of risks to yourself and others. Some considerations are given below: Control of Substances Hazardous to Health (COSHH) Using chemicals or other hazardous substances at work can put people s health at risk, so the law requires employers to control exposure to hazardous substances to prevent ill health. Employers have to protect people 4 Chapter 4: Legislation and Standards

5 Chapter 4 Legislation and Standards who may be exposed, by complying with the Control of Substances Hazardous to Health Regulations 1999 (COSHH). All places of work must be assessed to establish the risks. You should refer to your own local risk assessments and SOPs. Where possible, risks to health must be reduced by use of alternative substances or by the use of protective equipment. COSHH Data Sheets will be available for each substance. These give details such as: l Product Information l Emergency and First Aid Procedures l Health Hazard Information l Effects of Exposure l Handling and Storage Manual Handling You should observe your organisations procedures for lifting and handling, and should receive appropriate training follow your SOPs. In production areas, special care should be taken to check workstations and operator positioning to reduce risks l Check the positioning of your chair before you start work l Avoid overstretching and twisting l Take a break from repetitive movements at reasonable intervals to avoid strain Fire Safety Make sure you know what to do before you find yourself confronted by a fire. DO Know your fire instructions. Know where the fire extinguishers are in your area, how to use the fire extinguishers/ organisations policy on their use Know which is the right type of extinguisher to use. Know where the fire exits are. Know where the fire alarm manual pushes are in your area. Know the sound of the fire alarm. DON T Obstruct access to fire exits. Store items on top of fire extinguishers. Lock fire doors. Get changed from your cleanroom clothes on exit get out as soon as possible IN THE EVENT OF A FIRE: l Stop what you are doing. Leave it safe. l Start to exit. l Check adjacent rooms for other staff as you exit. l Do NOT get changed. l Do NOT collect personal belongings. l Leave unit by nearest appropriate exit. (Do not use a kick-panel if main exit is clear) l Exit the Pharmacy by the most appropriate exit. l Report to the senior member of staff for roll-call AND report the unit clear. l DO NOT re-enter until advised by senior member of staff. Dealing with a Product Spillage See Individual Product Data for Dealing with Spillages. You should: l Minimise the number of people in the area l Restrict access to the area l For cytotoxics use a designated spill kit l Be aware of your spillage SOP Chapter 4: Legislation and Standards 5

6 Aseptic Processing Reporting of Accidents/incidents *Report all accidents/incidents immediately* All accidents/incidents in the work place should be reported to a senior member of staff and an incident form completed immediately, detailing the incident and action taken. First Aid For accidental exposure to drug/cleaning agent see relevant COSHH data sheet. For needle stick injuries Individuals are expected to have a duty of care when handling sharps, however injuries may occur. Incidents should be reported on an accident form. These may be assessed by a senior person and action taken as necessary, in accordance with departmental procedures. Task There should be a copy of the Yellow Guide (Quality Assurance of Aseptic Preparation Services) available in your unit. Read through Section 16 Internal and External Audits. Make a note below of any additional points about audits that are relevant to your unit and you should be aware of: 6 Chapter 4: Legislation and Standards

7 Chapter 4 Legislation and Standards Test Yourself Write down as many examples of SOPs as you can remember (up to a maximum of 10). Put a tick next to any that you have already followed/used or read in your day-to-day work. Chapter 4: Legislation and Standards 7

8 Aseptic Processing Questions Q1 How often should licensed units be inspected by MHRA inspectors? (1) Q2 Who should carry out external audits? (2) Q3 What type of audits must be carried out by unlicensed units? (2) 8 Chapter 4: Legislation and Standards

9 Chapter 4 Legislation and Standards Q4 The following publications lay down the standards followed by all aseptic production units. What names are commonly used to refer to them, and what is the purpose of each publication? Official name Common name Purpose Aseptic dispensing for NHS Patients Rules and Guidance for Pharmaceutical Manufacturers and Distributors Quality Assurance of Aseptic Preparation Services (6) Chapter 4: Legislation and Standards 9

10 Aseptic Processing Q5 What does COSHH stand for? List 5 details that can be found on a COSHH datasheet (6) 10 Chapter 4: Legislation and Standards

Draft guidance for registered pharmacies preparing unlicensed medicines

Draft guidance for registered pharmacies preparing unlicensed medicines Draft guidance for registered pharmacies preparing unlicensed medicines January 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacies

More information

Introduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6

Introduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6 Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication

More information

How To Understand Your Role In A Pharmacy

How To Understand Your Role In A Pharmacy Element 1 Element 2 Assist with the maintenance of pharmaceutical Issue pharmaceutical 277 278 Element 1 Element 2 Assist with the maintenance of pharmaceutical Issue pharmaceutical Background See background

More information

Pharmacy Apprenticeships

Pharmacy Apprenticeships Pharmacy Apprenticeships JOB TITLE: BAND: BASE: Pharmacy Technician Pharmacy Department Pharmacy Assistant Pharmacy Department Apprentice Leicester Royal Infirmary Leicester General Hospital Glenfield

More information

11 MEDICATION MANAGEMENT

11 MEDICATION MANAGEMENT 1 11 MEDICATION MANAGEMENT OVERVIEW OF MEDICATION MANAGEMENT Depending on the size, structure and functions of the health facility, there may be a pharmacy with qualified pharmacists to dispense medication,

More information

INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS

INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS INSPECTORS CHECKLIST MONITORING AND INSPECTION VISITS About this document This document is a guide to show what the Inspectorate may look for during an inspection visit. It is intended for use by the GPhC

More information

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES

WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES WHS UNIT WORKPLACE HEALTH AND SAFETY AUDITING GUIDELINES Contents 1 Purpose... 1 2 Scope... 1 3 Definitions... 1 4 Responsibilities... 1 4.1 WHS Unit... 1 4.2 Auditor(s)... 1 4.3 Managers of Faculties

More information

Health and Safety Policy

Health and Safety Policy Health and Safety Policy Document Control Title : Health and Safety Policy Applicable to : All Staff and Executive Officers Date last reviewed : July 2015 Procedure Owner : People and Organisational Development

More information

Accreditation of a Dispensing and Pharmacy Assistant programme, Boots UK

Accreditation of a Dispensing and Pharmacy Assistant programme, Boots UK Accreditation of a Dispensing and Pharmacy Assistant programme, Boots UK Report of an accreditation event, 19 November 2010 Introduction The General Pharmaceutical Council (GPhC) is the statutory regulator

More information

OH&S Management Systems Audit Checklist (NAT, E3)

OH&S Management Systems Audit Checklist (NAT, E3) 3.1.2 3.1.1 Introduction OH&S Management Systems Audit Checklist (NAT, E3) This audit checklist is based on Element 3 (Implementation) of the National Self-Insurers OHS Audit Tool. For a full copy of the

More information

The Hub Dental Practice

The Hub Dental Practice The Hub Dental Practice Love Your Smile 799 Witan Gate, central Milton Keynes MK9 2FW Love Your Smile 01908 690326 reception@thehubdentalpractice.com www.thehubdentalpractice.com Dr David Gilmartin, Dental

More information

Health and Safety at Work Policy

Health and Safety at Work Policy Health and Safety at Work Policy Introduction Management of health and safety issues is an integral part of our business and is given the highest priority. Compliance with Health and Safety legislation

More information

Unit 205 Order, receive and store pharmaceutical stock

Unit 205 Order, receive and store pharmaceutical stock Element 1 Element 2 Element 3 Order pharmaceutical Receive pharmaceutical Store pharmaceutical 223 224 Element 1 Element 2 Element 3 Order pharmaceutical Receive pharmaceutical Store pharmaceutical Background

More information

Working for business. Workplace Safety Discount Application With employees

Working for business. Workplace Safety Discount Application With employees Working for business Workplace Safety Discount Application With employees What is the Workplace Safety Discount? Workplace Safety Discount provides a framework for building successful and sustainable workplace

More information

PROMG4 Install mining backup services

PROMG4 Install mining backup services Overview This standard is about: 1 interpreting information 2 adopting safe and healthy working practices 3 selecting materials, components and equipment 4 preparing, installing, using and removing below

More information

No. Name of Legislation Applicable Issues and Requirements Demonstration of Compliance 1. Health and Safety at Work Act 1974

No. Name of Legislation Applicable Issues and Requirements Demonstration of Compliance 1. Health and Safety at Work Act 1974 The Police Treatment Centres Health and Safety Legal Compliance Register No. Name of Legislation Applicable Issues and Requirements Demonstration of Compliance 1. Health and Safety at Work Act 1974 2.

More information

Professional Standards and Guidance for the Sale and Supply of Medicines

Professional Standards and Guidance for the Sale and Supply of Medicines Professional Standards and Guidance for the Sale and Supply of Medicines About this document The Code of Ethics sets out seven principles of ethical practice that you must follow as a pharmacist or pharmacy

More information

POLICY ON OCCUPATIONAL HEALTH AND SAFETY RISK MANAGEMENT

POLICY ON OCCUPATIONAL HEALTH AND SAFETY RISK MANAGEMENT THE NORTHCOTT SOCIETY POLICY ON OCCUPATIONAL HEALTH AND SAFETY RISK MANAGEMENT VOLUME: 2 Policy on Management and Organisational Issues SECTION: B Occupational Health & Safety & Workers Compensation SUB-SECTION:

More information

Licensed Pharmacy Technician Scope of Practice

Licensed Pharmacy Technician Scope of Practice Licensed Scope of Practice Adapted from: Request for Regulation of s Approved by Council April 24, 2015 Definitions In this policy: Act means The Pharmacy and Pharmacy Disciplines Act means an unregulated

More information

Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials

Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials 1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials

More information

A Guide to Pharmacy Documentation For Clinical Trials

A Guide to Pharmacy Documentation For Clinical Trials A Guide to Pharmacy Documentation For Clinical Trials Roy Sinclair Clinical Trials Pharmacist St. George s Hospital (to Sep 2007) Lecturer Kingston University January 2008 A Guide to Pharmacy Documentation

More information

Hospital pharmacy technician role / service definition grid

Hospital pharmacy technician role / service definition grid Hospital pharmacy technician role / service definition grid To be a competent hospital pharmacy technician, you must be able to complete the required task to the defined standard and to do this on every

More information

Level 2 Certificate in Pharmaceutical Science (5356-02)

Level 2 Certificate in Pharmaceutical Science (5356-02) Level 2 Certificate in Pharmaceutical Science (5356-02) Qualification handbook for centres 500/9575/4 www.cityandguilds.com September 2010 Version 1.0 About City & Guilds City & Guilds is the UK s leading

More information

The Quality System for Drugs in Germany

The Quality System for Drugs in Germany The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute

More information

4 Quality Standards - Human Resources. Contents. 4.0 Introduction. 4.1 Management Structure and Staffing Levels

4 Quality Standards - Human Resources. Contents. 4.0 Introduction. 4.1 Management Structure and Staffing Levels 4 Quality Standards - Human Resources Contents 4.0 Introduction 4.1 Management Structure and Staffing Levels 4.2 Contracts, Job Descriptions & Person Specifications 4.3 Recruitment, Selection and Leaving

More information

QUALIFICATION HANDBOOK

QUALIFICATION HANDBOOK QUALIFICATION HANDBOOK Level 2 and 3 NVQ Certificate in Rail Engineering Traction and Rolling Stock (7597-05/10) September 2011 Version 1.1 (September 2011) Qualification at a glance Subject area Rail

More information

A Guide to developing BROTHEL OPERATIONAL PLANS POLICIES AND PROCEDURES

A Guide to developing BROTHEL OPERATIONAL PLANS POLICIES AND PROCEDURES A Guide to developing BROTHEL OPERATIONAL PLANS POLICIES AND PROCEDURES Scope and Purpose of this Guide The purpose of this guide is to provide licensees with the key that may be addressed when developing

More information

HEALTH & SAFETY BICS ULTIMATE GUIDE HEALTH SAFETY

HEALTH & SAFETY BICS ULTIMATE GUIDE HEALTH SAFETY BICS ULTIMATE GUIDE TO HEALTH & SAFETY Health and Safety is an integral part of the management of any activity. The Societies Office is committed to health and safety and this dedication cannot be met

More information

Workplace Injury & Illness Prevention Program

Workplace Injury & Illness Prevention Program Workplace Injury & Illness Prevention Program ID Analytics Inc. For non-high hazard employers RESPONSIBILITY The Injury and Illness Prevention (IIP) Program administrator is Janet Wickens, Director Human

More information

Information for Law Firms from the Employment & Equality Law Committee. Sample Health & Safety Policy

Information for Law Firms from the Employment & Equality Law Committee. Sample Health & Safety Policy Information for Law Firms from the Employment & Equality Law Committee Sample Health & Safety Policy 1 Sample Health & Safety Policy Sample contracts, policies and guidelines prepared by the Law Society

More information

School of Engineering University of Glasgow

School of Engineering University of Glasgow School of Engineering University of Glasgow Electronics Workshops Rankine Building 319A (2 Technicians) 510 (1 Technician) 712A (4 Technicians, 1 Modern Apprentice) James Watt South 619 (2 Technicians)

More information

TAUNTON & SOMERSET NHS FOUNDATION TRUST Department of Pharmacy Clinical Support Division. Job description

TAUNTON & SOMERSET NHS FOUNDATION TRUST Department of Pharmacy Clinical Support Division. Job description TAUNTON & SOMERSET NHS FOUNDATION TRUST Department of Pharmacy Clinical Support Division Job description JOB TITLE: GRADE: PLACE OF WORK: HOURS: RESPONSIBLE TO: ACCOUNTABLE TO: Pre-Registration - PHARMACY

More information

Audits must be conducted with due concern for employee safety and environmental protection.

Audits must be conducted with due concern for employee safety and environmental protection. Standard Operating Procedure Title: GMP Audit Procedure Related Documents TEM-080 Internal Audit Report Template TEM-120 Vendor Audit Report Template Form-385 Vendor Audit Questionnaire Form-445 EHS Workplace

More information

Health and Safety (Sharp Instruments in Healthcare) Regulations 2013

Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 Guidance for employers and employees HSE information sheet Health Services Information Sheet 7 This information sheet is for healthcare

More information

Unit Title: Unit purpose and aim

Unit Title: Unit purpose and aim Unit Title: Preparing and Operating Telescopic Handlers to Lift and Transfer Loads in the Workplace Level: 2 Credit value: 25 Guided learning hours: 83 Unit expiry date: 31/10/2014 Unit purpose and aim

More information

Unit Title: Unit purpose and aim

Unit Title: Unit purpose and aim Unit Title: Preparing and Operating Sideloader Forklifts to Lift and Transfer Loads in the Workplace Level: 2 Credit value: 16 Guided learning hours: 53 Unit expiry date: 31/10/2014 Unit purpose and aim

More information

Pollution Incident Response Plan

Pollution Incident Response Plan Pollution Incident Response Plan Introduction Schmidt Quarries is committed to ensuring all aspects of our quarrying activities comply with the environmental legislative requirements in NSW. This Pollution

More information

How To Inspect A Blood Bank

How To Inspect A Blood Bank Site visit inspection report on compliance with HTA minimum standards Belfast Cord Blood Bank HTA licensing number 11077 Licensed for the procurement, processing, testing, storage, distribution and import/export

More information

Recent Updates on European Requirements and what QPs are expected to do

Recent Updates on European Requirements and what QPs are expected to do Recent Updates on European Requirements and what QPs are expected to do QP Forum 28/29 November 2013, Lisbon Dr. Bernd Renger Modified: Georg Goestl 1 Written Conformation for API-Import Actual Status

More information

University of Wisconsin-Stout. Occupational Safety & Health Plan. Overview

University of Wisconsin-Stout. Occupational Safety & Health Plan. Overview University of Wisconsin-Stout Occupational Safety & Health Plan Overview Wisconsin Statutes 101.055 and Wisconsin Administrative Code (Comm 32.11) require all public employers to develop and implement

More information

Level 2 Certificate in Warehousing and Storage Skills (QCF)

Level 2 Certificate in Warehousing and Storage Skills (QCF) Level 2 Certificate in Warehousing and Storage Skills (QCF) Qualification Handbook www.cityandguilds.com September 2010 Version 1.1 Level 2 Certificate 1016-02 QAN 501/1082/2 About City & Guilds City &

More information

Jonathan Wilson. Sector Manager (Health & Safety)

Jonathan Wilson. Sector Manager (Health & Safety) Jonathan Wilson Sector Manager (Health & Safety) OHSAS 18001:2007 Making Life Easier For Health & Safety Managers Workshop Agenda 1. Introduction 2. Why Manage Health & Safety 3. OHSAS 18001 and OHSMS

More information

Asbestos Policy ASBESTOS POLICY. Version 2 / Jun 2015 Page 1 of 11 Asbestos Policy

Asbestos Policy ASBESTOS POLICY. Version 2 / Jun 2015 Page 1 of 11 Asbestos Policy ASBESTOS POLICY Version 2 / Jun 2015 Page 1 of 11 Asbestos Policy This is a controlled document. It should not be altered in any way without the express permission of the author or their representative.

More information

ASA HEALTH AND SAFETY POLICY

ASA HEALTH AND SAFETY POLICY ASA HEALTH AND SAFETY POLICY Policy statement The ASA places great importance on the health and safety of all its employees, visitors and the general public. Temporary staff, contractors and visitors will

More information

BASIC HEALTH AND SAFETY POLICY

BASIC HEALTH AND SAFETY POLICY BASIC HEALTH AND SAFETY POLICY 1 In the following pages is an example of a basic health and safety policy. The text in the square brackets [ ] provide instructions on how to complete any gaps in the policy.

More information

Health & Safety Policy For Locations Hosting Film Production Companies

Health & Safety Policy For Locations Hosting Film Production Companies Health & Safety Policy For Locations Hosting Film Production Companies Throughout this document, the location will be referred to as The Venue and the film production company as The Contractor. The following

More information

POST TITLE : Pre-registration Trainee Pharmacy Technician

POST TITLE : Pre-registration Trainee Pharmacy Technician Pharmacy Department JOB DESCRIPTION POST TITLE : Pre-registration Trainee Pharmacy Technician GRADE : Year 1 70% Top of Band 4 Year 2 75% Top of Band 4 DEPARTMENT : Pharmacy Department DIRECTORATE : Clinical

More information

Domestic Assistants/Housekeepers A Workbook to record your training and personal development

Domestic Assistants/Housekeepers A Workbook to record your training and personal development / A Workbook to record your training and personal development Healthcare Associated Infection HAI is defined as an infection originating in a healthcare facility, which was not present or incubating at

More information

1. 2. Health, safety and. Unit 1: Principles of personal responsibilities and how to develop and evaluate own performance at work

1. 2. Health, safety and. Unit 1: Principles of personal responsibilities and how to develop and evaluate own performance at work 1. 2 security Health, safety and procedures All employers and employees have a responsibility to adhere to the legislation that affects them, such as: health and safety legislation, which may relate to

More information

New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Safeguarding public health New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Tony Orme, Senior GDP Inspector Inspection, Enforcement and Standards Division

More information

RMM 501 Hazardous Materials Management Systems Including WHMIS Program Page 2 November 2014

RMM 501 Hazardous Materials Management Systems Including WHMIS Program Page 2 November 2014 RMM 501 Hazardous Materials Management Systems Including WHMIS Program Page 2 3.4 McMaster University RMM #300 Safety Orientation and Training Program 3.5 McMaster University RMM #301 Standard Operating

More information

COSVR404 Erect and dismantle plant (cranes and rigs)

COSVR404 Erect and dismantle plant (cranes and rigs) Overview This standard is about interpreting information, adopting safe, healthy and environmentally responsible work practices, selecting materials, components, plant, tools and ancillary equipment, preparing

More information

HEALTH AND SAFETY MANAGEMENT

HEALTH AND SAFETY MANAGEMENT Health & Safety Services Unit name goes here Safety Code of Practice 2 Part A 5 th Edition, November 2015 Unit name goes here HEALTH AND SAFETY MANAGEMENT Organisation and Responsibilities University of

More information

1 OF 6 3. SUBMISSION REQUIREMENTS FOR APPLICATION FOR APPROVAL TO OPERATE A PHARMACEUTICAL BUSINESS

1 OF 6 3. SUBMISSION REQUIREMENTS FOR APPLICATION FOR APPROVAL TO OPERATE A PHARMACEUTICAL BUSINESS 1 OF 6 D R U G S R E G U L A T O R Y U N I T Ministry of Health M i n i s t r y o f H e a l t h H e a d q u a r t e r s F l o o r 3, B l o c k D G o v e r n ment E n c l a ve P / B a g 0 0 3 8 G a b o

More information

PROVISION OF SAFETY, HEALTH AND ENVIRONMENT TRAINING

PROVISION OF SAFETY, HEALTH AND ENVIRONMENT TRAINING PROVISION OF SAFETY, HEALTH AND ENVIRONMENT TRAINING Safety Code No 10 Rev. 1.5, Issued March, 2015 Note - This document may have been superseded by a more recent version. Version History 1 Initial launch

More information

Safety Meeting Topic: Chemical Spills and Emergency Action Plans for General Industry

Safety Meeting Topic: Chemical Spills and Emergency Action Plans for General Industry Company Name: Safety Meeting ID: 16 Date: Grainger Safety Services Inc. 2012 Safety Meeting Topic: Chemical Spills and Emergency Action Plans for General Industry UPDATED: This safety meeting has been

More information

QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES

QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PIC/S September

More information

Employee Health and Safety Induction Training Record

Employee Health and Safety Induction Training Record COMPANY NAME Employee Health and Safety Induction Training Record Employee name Job Title Department Start Date - PBS 2010/2 Employee Health & Safety Induction Training Record Page 1 of 6 INDUCTION TRAINING

More information

HSE Guidelines for maintaining the vaccine cold-chain including maintenance of vaccine fridges and management of vaccines

HSE Guidelines for maintaining the vaccine cold-chain including maintenance of vaccine fridges and management of vaccines HSE Guidelines for maintaining the vaccine cold-chain including maintenance of vaccine fridges and management of vaccines Document reference number Revision number Approval date NIO01 Document developed

More information

Injury & Illness (IIPP)

Injury & Illness (IIPP) Associated Students, Inc. Injury & Illness Prevention Program (IIPP) Created on September 26, 2005 ASSOCIATED STUDENTS, INCORPORATED CALIFORNIA STATE POLYTECHNIC UNIVERSITY, POMONA EMPLOYEE ACKNOWLEDGEMENT

More information

Health & Safety Policy DH Associates Limited

Health & Safety Policy DH Associates Limited General Statement of Policy Health & Safety Policy DH Associates Limited It is the policy of DH Associates Ltd to comply with the terms of the Health and Safety at Work etc Act 1974 and subsequent legislation

More information

AFTRS Health and Safety Risk Management Policy

AFTRS Health and Safety Risk Management Policy AFTRS Health and Safety Risk Management Policy Responsible Officer Contact Officer Authorisation Director, Corporate and Student Services Head of Human Resources Chief Executive Officer Effective Date

More information

Hazard Identification, Risk Assessment And Control Procedure

Hazard Identification, Risk Assessment And Control Procedure Hazard Identification, Risk Assessment And Control Procedure 1. Purpose 1.1 To ensure that there is a formal process for hazard identification, risk assessment and control to effectively manage hazards

More information

Risk Management & Assessment at UQ

Risk Management & Assessment at UQ Risk Management & Assessment at UQ Course Overview: This training module has been developed for workers at the University of Queensland, and forms part of the OH&S training program at UQ. The aim of this

More information

Workshop Self Inspection Checklist WORK01

Workshop Self Inspection Checklist WORK01 Workshop Self Inspection Checklist WORK01 General Mechanical Workshops Location Assessor Date This core checklist is provided by the Health and Safety Department as a template, which provides a basic framework

More information

COMMISSION DIRECTIVE 2003/94/EC

COMMISSION DIRECTIVE 2003/94/EC L 262/22 COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal

More information

GUIDANCE ON THE SAFE HANDLING OF MONOCLONAL ANTIBODY (mab) PRODUCTS

GUIDANCE ON THE SAFE HANDLING OF MONOCLONAL ANTIBODY (mab) PRODUCTS GUIDANCE ON THE SAFE HANDLING OF MONOCLONAL ANTIBODY (mab) PRODUCTS 5 th Edition November 2015 NHS Pharmaceutical Quality Assurance Committee 2015 British Oncology Pharmacists Association Pharmaceutical

More information

1. GENERAL STATEMENT OF COMPANY HEALTH, SAFETY AND ENVIRONMENTAL POLICY

1. GENERAL STATEMENT OF COMPANY HEALTH, SAFETY AND ENVIRONMENTAL POLICY 1. GENERAL STATEMENT OF COMPANY HEALTH, SAFETY AND ENVIRONMENTAL POLICY Dumfries Timber Co. Ltd. is committed to comply with our legal duties in order to provide a safe and healthy working environment

More information

Issue: June 2009 PROFESSIONAL STANDARDS AND GUIDANCE FOR THE SALE AND SUPPLY OF MEDICINES

Issue: June 2009 PROFESSIONAL STANDARDS AND GUIDANCE FOR THE SALE AND SUPPLY OF MEDICINES Issue: June 2009 PROFESSIONAL AND GUIDANCE FOR THE SALE AND SUPPLY OF MEDICINES PROFESSIONAL AND GUIDANCE FOR THE SALE AND SUPPLY OF MEDICINES CONTENTS Status of this document About this document 1 Pharmaceutical

More information

OSHA Compliance Checklist ASC

OSHA Compliance Checklist ASC OSHA Compliance Checklist ASC Date Inspectors Facility OSHA is the agency responsible for establishing and enforcing standards that will make the workplace safe and healthful for the employees. The way

More information

ENVIRONMENTAL ASPECTS REGISTER (ISO 14001)

ENVIRONMENTAL ASPECTS REGISTER (ISO 14001) ENVIRONMENTAL ASPECTS REGISTER (ISO 14001) 1. Scope The scope of this Environmental Aspects Register covers the following operational areas: Aberdeen Region (A); Cumbernauld Region (C); Warrington Region

More information

Safety Resources from

Safety Resources from Safety Resources from Sample Safety Program TABLE OF CONTENTS I. DECLARATION OF POLICY II. DUTIES AND RESPONSIBILITIES III. SAFETY COMMITTEE IV. PROGRAM REINFORCEMENT V. CORPORATE DRUG POLICY VI. HAZARD

More information

Small Business. Safety Solutions

Small Business. Safety Solutions Small Business Safety Solutions Introduction ACCI would like to thank the South Australian WorkCover Corporation for their assistance in the development of Small Business Safety Solutions (2004). Important

More information

OCCUPATIONAL HEALTH AND SAFETY POLICY: INCIDENT AND INJURY REPORTING ERJ 6.28.1

OCCUPATIONAL HEALTH AND SAFETY POLICY: INCIDENT AND INJURY REPORTING ERJ 6.28.1 OCCUPATIONAL HEALTH AND SAFETY POLICY: INCIDENT AND INJURY REPORTING ERJ 6281 INTRODUCTION The Edmund Rice Justice Aotearoa New Zealand Trust recognises that the health and safety of its employees is a

More information

Waste Management Policy

Waste Management Policy HEALTH AND SAFETY ISSUES Waste Management Policy Policy No: 39 Date of issue: October 1998 Review Dates: August 2001, December 2003, July 2008 Date to be Reviewed: July 2010 Page 1 of 13 Date of Issue:

More information

Responding to complaints and concerns

Responding to complaints and concerns Responding to complaints and concerns Guidance Note: September 2010 Guidance Note: Responding to Complaints and Concerns The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians

More information

Adoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012

Adoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012 10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular

More information

HEALTH AND SAFETY POLICY AND PROCEDURES

HEALTH AND SAFETY POLICY AND PROCEDURES HEALTH AND SAFETY POLICY AND PROCEDURES 1 Introduction 1. The Health and Safety at Work etc. Act 1974 places a legal duty on the University to prepare and revise as often as may be appropriate, a written

More information

Health & Safety Management System Manual

Health & Safety Management System Manual Health & Safety Management System Manual Document Information Document Number Description HSMSM This manual describes the Health & Safety Management System elements of the Integrated Management System

More information

OH&S MANAGEMENT SYSTEM CHECKLIST - AS 4801:2001 (STATUS A = Acceptable; N = Not Acceptable; N/A = Not Applicable)

OH&S MANAGEMENT SYSTEM CHECKLIST - AS 4801:2001 (STATUS A = Acceptable; N = Not Acceptable; N/A = Not Applicable) OH&S MANAGEMENT SYSTEM CHECKLIST - AS 4801:2001 (STATUS A = Acceptable; N = Not Acceptable; N/A = Not Applicable) 4.1 General Requirements 4.2 OHS policy Has the organisation an established and maintained

More information

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS

JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS JANUARY 2013 PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTS 1 WHAT IS A SITE MASTER FILE? A Site Master File (SMF) is a document prepared by the manufacturer containing specific

More information

THE SAFE AND SECURE A TEAM APPROACH HANDLING OF MEDICINES: March 2005

THE SAFE AND SECURE A TEAM APPROACH HANDLING OF MEDICINES: March 2005 March 2005 THE SAFE AND SECURE HANDLING OF MEDICINES: A TEAM APPROACH A revision of the Duthie Report (1988) led by the Hospital Pharmacists Group of the Royal Pharmaceutical Society Preface A prescribed

More information

Policy for the Management of Asbestos in Buildings

Policy for the Management of Asbestos in Buildings in Buildings Health and Safety Services 1 A1. Introduction If asbestos fibres enter the lungs they can cause cancer or incurable disease. Consequently the University is committed to ensure that all reasonably

More information

RTC - HB004202 SAFETY & SECURITY FEATURES

RTC - HB004202 SAFETY & SECURITY FEATURES SAFETY & SECURITY FEATURES 1. GUEST ROOM PROVISIONS External locks Secondary locking device for entry and connecting doors Entry door viewer Self-closing entry door In room safes or central safety deposit

More information

Risk Assessment. Module 1. Health & Safety. Essentials. 16-23 November 2013. Registered charity number 207890

Risk Assessment. Module 1. Health & Safety. Essentials. 16-23 November 2013. Registered charity number 207890 Risk Assessment Module 1 Risk assessment in the laboratory After studying this module you will be able to understand the need to conduct risk assessments, how this applies to all laboratory activities,

More information

Health Information and Quality Authority Regulation Directorate

Health Information and Quality Authority Regulation Directorate Health Information and Quality Authority Regulation Directorate Compliance Monitoring Inspection report Designated Centres under Health Act 2007, as amended Centre name: Centre ID: Kilbrew Recuperation

More information

Edwin Lindsay Principal Consultant. Compliance Solutions (Life Sciences) Ltd, Tel: + 44 (0) 7917134922 E-Mail: elindsay@blueyonder.co.

Edwin Lindsay Principal Consultant. Compliance Solutions (Life Sciences) Ltd, Tel: + 44 (0) 7917134922 E-Mail: elindsay@blueyonder.co. Edwin Lindsay Principal Consultant, Tel: + 44 (0) 7917134922 E-Mail: elindsay@blueyonder.co.uk Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes

More information

A Short Guide to The Safety, Health and Welfare at Work Act, 2005

A Short Guide to The Safety, Health and Welfare at Work Act, 2005 A Short Guide to The Safety, Health and Welfare at Work Act, 2005 3 A Short Guide to the Safety, Health and Welfare at Work Act, 2005 Published in August 2005 by the Health and Safety Authority, 10 Hogan

More information

Summary of the role and operation of NHS Research Management Offices in England

Summary of the role and operation of NHS Research Management Offices in England Summary of the role and operation of NHS Research Management Offices in England The purpose of this document is to clearly explain, at the operational level, the activities undertaken by NHS R&D Offices

More information

COLUMBUS STATE COMMUNITY COLLEGE EMPLOYEE SAFETY MANUAL

COLUMBUS STATE COMMUNITY COLLEGE EMPLOYEE SAFETY MANUAL COLUMBUS STATE COMMUNITY COLLEGE EMPLOYEE SAFETY MANUAL HAZARDOUS MATERIAL MANAGEMENT Effective October 15, 1995 Page 1 of 4 Updated August, 2008 Revised August, 2009 A. Columbus State Community College

More information

B37: Managing Occupational Road Risk: Guidance. This document should be read in conjunction with Section B37: Managing Occupational Road Risk: Policy.

B37: Managing Occupational Road Risk: Guidance. This document should be read in conjunction with Section B37: Managing Occupational Road Risk: Policy. B37: Managing Occupational Road Risk: Guidance This document should be read in conjunction with Section B37: Managing Occupational Road Risk: Policy. 1. Introduction 1.1 This document outlines the mechanisms

More information

Policy Document Control Page

Policy Document Control Page Policy Document Control Page Title Title: Medical Devices Management Policy Version: 10 Reference Number: CO16 Supersedes Supersedes: Version 9 Description of Amendment(s): Originator Addition of 4.8 Sharps

More information

Compilation of Community Procedures on Inspections and Exchange of Information

Compilation of Community Procedures on Inspections and Exchange of Information EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 3 October 2014 EMA/572454/2014 Rev 17 Compliance and Inspection Compilation of Community

More information

Draft guidance for registered pharmacies providing internet and distance sale, supply or service provision

Draft guidance for registered pharmacies providing internet and distance sale, supply or service provision Draft guidance for registered pharmacies providing internet and distance sale, supply or service provision September 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy

More information

How To Be A Senior Pharmacy Technician

How To Be A Senior Pharmacy Technician JOB DESCRIPTION JOB TITLE : Senior Pharmacy Technician DEPARTMENT : Pharmacy Heartlands, Solihull & Good Hope Hospitals GRADE : Band 5 HOURS OF DUTY : 37.5 hours per week. The Trust operates a 7 day working

More information

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics

More information

Elements of Occupational Safety. Introduction. Policy Development

Elements of Occupational Safety. Introduction. Policy Development Introduction If you are a factory owner or manager, you cannot simply look at safety and health problems on an ad hoc basis and hope that the conditions in your workplace comply with national and international

More information

Benchmark OHS Consulting Pty Ltd Self Assessment WHS Audit Tool

Benchmark OHS Consulting Pty Ltd Self Assessment WHS Audit Tool Benchmark OHS Consulting Pty Ltd Self Assessment WHS Audit Tool This WHS Auditing System Tool is to be used as a self-assessment of YOUR COMPANY compliance with AS 4801 and the Work Health and Safety Act

More information

32 PROMOTE, MONITOR AND MAINTAIN HEALTH, SAFETY AND SECURITY IN THE WORKING ENVIRONMENT

32 PROMOTE, MONITOR AND MAINTAIN HEALTH, SAFETY AND SECURITY IN THE WORKING ENVIRONMENT Unit overview Elements of competence 32a 32b 32c Monitor and maintain the safety and security of the working environment Promote health and safety in the working environment Minimise risks arising from

More information

Corporate Health and Safety Policy

Corporate Health and Safety Policy Corporate Health, Safety & Wellbeing Service Corporate Health and Safety Policy Contents 1. Introduction... 2 2. Policy Statement... 2 3. Scope... 3 4. Definition of Manager... 4 5. Responsibilities...

More information