EHS Manual - Final

WINTHROX LABORATORIES PVT.
LTD
Environmental Health And Safety Department
EHS MANUAL
(Environmental Health And Safety Management System)
ENVIRONMENTAL
HEALTH AND SAFETY MANUAL
WINTHROX LABORATORIES PVT. LTD
EHS MANUAL
Table of Contents
A. SIGNATURE AND APPROVAL

B. TABLE OF CONTENT
C. LIST OF SOP
1.0. INTRODUCTION
2.0. COMMITMENT TO ENVIRONMENTAL HEALTH AND SAFETY
3.0 TERMS & DEFINITIONS.
4.0 CONTEXT OF THE WINTHROX LABORATORIES PVT. LTD
5.0 LEADERSHIP
6.0 PLANNING
7.0 SUPPORT
8.0 OPERATION
9.0 PERFORMANCE EVALUATION
10. IMPROVEMENT
GENERAL (DETAILED)
EHS MANUAL
ENVIRONMENTAL HEALTH AND SAFETY MANAGEMENT SYSTEM
Signatures & Approvals
Dr. Shafaq Ali Syed Signature:________________

Prepared by : (Executive RA)
_
Mr. Mazhar
Reviewed by : (QA Manager) Signature:_______________
Mrs.Shahnaz Mukhtar
Reviewed (Plant Manager)
by: Signature:
________________
Rizwan Umer Shaikh Signature:

: (CEO) Signature:__________________
Approved by
EHS MANUAL
List of Available SOP Related to Quality Management System Standard Clauses
 SOP for EHS policy

 SOP for Mock fire drill
 SOP for Medical Examination
 SOP for First Aid Box
 SOP for Internal External Communication
 SOP for Context of the Organization
 SOP for Electrical Safety
 SOP of Microbiological Section EHS Objectives
 SOP of liquid Injectable area EHS Objectives
 SOP for Operation of the lux meter and monitoring the lux level
 SOP for Operation of the noise meter and monitoring the noise level
 SOP for EHS QC objectives
 SOP for health and safety incident reporting
 SOP for spill kit and chemical spill
 SOP for prevention from covid-19
 SOP for emergency and response plan
 SOP for tool box meeting
 SOP for operation of fire extinguisher
 SOP for objectives of liquid manufacturing area
 SOP for EHS objectives of eye drops (sterile area)
 SOP for EHS objectives of oral solid dosage form
 SOP for EHS objectives of HR
 Sop for internal audits
 Sop for legal and other requirement
 Sop for Water, Energy Conservation
EHS MANUAL
General Information of document
Document Name EHS MANUAL
Document Location EHS Department
Associated Documentation SOP Related to EHS Management System
Dr.Shafaq
Document controller & Pharm-D, MBA, Regulatory Affairs certification from
author DHA,UAE
Executive Winthrox Laboratories Pvt Ltd
Document Change History
Change Date Reason
1st Published 10.02.2021 New

EHS MANUAL
1. INTRODUCTION
Winthrox Laboratories Pvt. has developed and implemented an Environmental Health and Safety
Management System (EHS) that uses ISO 45001 and ISO 14001 as a framework for our
organization to document and improve our operational practices in order to prevent work-related
injury and ill-health and environmental impact. Certification and/or compliance with ISO 45001 and
ISO 14001 help our organization to achieve its intended outcomes and demonstrate that our
Environmental health and safety management system is effective. Winthrox Laboratories
organization’s management system documents help translate our corporate intentions to prevent
incidents into a systematic and ongoing set of processes that are supported by the use of appropriate
methods and tools, that can reinforce our commitment to proactively improving our performance.
The Figure below illustrates our methodology for the development of our Environmental health and
safety management system, which uses the plan, do, check and act cycle to implement the process
approach that delivers management system objectives, stakeholder requirements and worker safety.
EHS MANUAL
Figure 1: Health and Safety Management System Process Model

Internal & External Issues Affecting Needs & Expectations of Workers/Employs &
Environmental Health & Safety Management Other Interested Parties
Understanding the context of the Winthrox Laboratories Pvt. Ltd including

EHS risks and opportunities. Establishing EHS objectives, processes and
resources required to deliver results in accordance with the EHS policy.
PLAN
Take actions to
Operation
continually Implement the
improve, processes as
including acting Leadership and Worker planned to
on findings of Participation including worker
incidents, participation,
addressing non hazard
ACT DO
conformances identification and
and audit emergency
findings. CHECK
preparedness
Monitor, measure, and evaluate EHS activities and

processes.
EHS MANUAL
This health and safety management system manual is used to familiarise our workers, employs,
customers, interested parties, or individuals with the controls that have been implemented and to
assure them that the integrity of our management system is maintained and is focused on meeting its
intended outcomes.
This manual also describes the structure and interactions of our environmental health and safety
management system, delineates authorities, interrelationships and responsibilities of personnel who
operate within the boundaries of your environmental health and safety management system (EHS),
whilst providing a reference to the procedures, process, forms and activities that comprise it.
The goals of our health and safety management system are to provide guidance for the development
of a framework where injuries, property damage, and other loss causing incidents are mitigated. The
stated goals of our environmental health and safety management system are:
1. Development of an environmental health and safety policy;

2. Demonstration of leadership and commitment to environmental health and safety;
3. Establishing systematic processes for safety management;
4. Conducting hazard identification efforts;
5. Creating operational health and safety controls;
6. Increasing awareness and knowledge for employees about environmental health and safety;
7. Evaluating safety performance and develop plans to improve continuously;
8. Establishing the necessary competencies;
9. Creating and fostering a safety culture within our organization;
10. Ensuring employees participate fully and meaningfully in the environmental health and safety
process;
11. Meeting all legal and regulatory requirements.
The scope of this document describes our environmental health and safety management system,
delineates authorities, interrelationships, and responsibilities of process owners and personnel that
operate within the management system and the sequence and interaction of our processes.
EHS MANUAL
The scope of this manual shall be applicable to the following areas:

 Head office
 Manufacturing area
 Warehouse
 Quality/Micro Laboratory
 Research & Development laboratory
References
In addition to ISO 45001, ISO 14001
Document Review
This manual or parts of it shall be revised on an annual basis or as necessary to reflect changes in
operations or regulatory requirements.
EHS MANUAL
2. COMMITMENT TO ENVIRONMENTAL HEALTH AND SAFETY
EHS POLICY STATEMENT

WINTHROX LABORATORIES PVT. LTD believe that Environment, Health & Safety controls
hold greater importance in production, analysis, distribution of medicine and considered equal with
all business functions.
1. We committed to meet all applicable national / international standards & regulations of EHS.
2. WINTHROX LABORATORIES PVT. LTD integrated EHS management system into

business operation to enhance customer satisfaction, minimize EHS risks/hazards and environmental
pollution/risks.
3. WINTHROX LABORATORIES PVT. LTD establishes, maintain and ensure the EHS
management system by setting goals in production, analysis, distribution of medicine so as to
safeguards environmental health & safety of its employees, consumers, contractors & concerned
interested parties.
4. At WINTHROX LABORATORIES PVT. LTD we encourage, communicate and ensure

employees participation in order to continual improvement in the EHS management system through
training and information.
____________________________
Approved by: CEO
EHS MANUAL
2.1. Environmental Health and Safety Policy

Policy sop
1.0. Introduction:
Winthrox Laboratories Pvt. Ltd is committed to maintaining excellence in environment,
health and safety (EHS) in all aspects of its company. We adhere to documented system and
procedure which ensure that our production comply with national laws and regulations and
do not pose any harm to our community and environment.
2.0. Policy Objective:
It is the objective of this policy that all employee should be fully aware of their resposibility
for the protection of environment and to provide a safe and hazard free enviornment.
3.0. Scope & Rationale:
This Policy is applicable in the entire Winthrox Laboratories Pvt. Ltd al operation and
distribution operation. It is the aim of Winthrox Laboratories Pvt. Ltd to have a seamless
environmental health and safety, environment that takes into account economic and
ecological considerations in equal measure.
4.0. Procedure:
4.1. An efficient environment, health and safety management system reduces the risk
and chances of accidents to employee and environment. It is about the protection
of our employee’s health. There is a wide range offer of preventive actions to
strongly promote the health consciousness as well as the health of our employee.
4.2. We have implemented EHS program in the department. All important EHS
decisions are made using management consisting of various experts.
4.3. The management of Winthrox Laboratories Pvt. Ltd is responsible for
implementing the action in the different departments in addition staff members
of different operating area will directly involve in the implementation.
4.4. They will be trained accordingly and act as an EHS Coordinator and will be
available. All staff member should know their task and are aware of their
personal responsibility when it comes to reducing accident risks and to
preventing health impairments, wasting resources and environmental damage.
EHS MANUAL
4.5. Winthrox Laboratories Pvt. Ltd take the economical use of natural resources very
seriously by keeping in within the limits. In order to identify improvement
potentials and ensure the effectiveness of our EHS System, regular audits are
being performed in addition to internal inspection.
4.6. The management expects all employees to be cooperative and supportive in this
effort.
4.7. Winthrox Laboratories Pvt. Ltd in form all employees about essential
environmental aspects such as water consumption, use of energy. Training and
individual counseling is also provided.
5.0. Conclusion:
This policy ensures that concrete objective and actions of environmental and resource
protection are implemented in all division of the company focusing on avoiding and reducing
environmental damage.
6.0. References :
S. No. Description
6.1 45001
6.2 14001
EHS MANUAL
3.0 Terms & Definitions.
3.1 Abbreviation:
EHSMS : Environmental Health and Safety Management System

EHS Coordinators : Environmental Health and Safety Representative
WI : Work Instructions
3.2 Definition:
1. Acceptable risk: risk that has been reduced to a level that can be tolerated by Winthrox
Laboratories Pvt. Ltd having regard to legal obligations and the company’s Environmental
Health and Safety Policy.
2. Audit: Systematic, independent and documented process for obtaining ‘audit evidence’
and evaluating it objectively to determine the extent to which ‘audit criteria’ are fulfilled.
3. Continual improvement: year on year improvements in both Winthrox Laboratories
Pvt. Ltd’s environmental health and safety performance and the Environmental Health and
Safety System.
4. Corrective action: action to eliminate the cause of a nonconformity or other undesirable
situation.
5. Document: hard copy or electronic information in written, diagrammatic or pictorial
form.
6. Hazard: source, situation or act with a potential for harm in terms of injury or ill health.
7. Hazard identification: the process of recognizing that a hazard exists and defining its
characteristics.
8. Ill health: identifiable, adverse physical or mental condition arising from and/or made
worse by a work activity and/or work-related situation.
9. Incident: work-related event in which an injury or ill health or fatality occurred or could
have occurred.
Note 1: An accident is an incident which has given rise to injury, ill health, or fatality.
Note 2: An incident where no injury, ill health or fatality occurred is referred to as a near
miss.
Note 3: A dangerous occurrence is a particular type of near miss.
Note 4: An emergency situation is a particular type of incident.
10. Interested party: person or group outside the workplace concerned with or affected by
the EHS performance of the company.
11. Nonconformity: non-fulfillment of a requirement.
EHS MANUAL
12. Environmental health and safety (EHS): conditions and factors that affect, or could
affect, the health and safety of employees or other workers (including temporary workers
and contractor personnel), visitors or any other person in the workplace.
13. EHS management system: part of an organization’s management system used to
develop and implement its EHS policy and manage its EHS risks.
14. EHS objective: EHS goal, in terms of EHS performance set annually by Winthrox
Laboratories Pvt. Ltd in order to achieve one of its Environmental Health and Safety Policy
commitments.
15. EHS performance: measurable results of Winthrox Laboratories Pvt. Ltd’s management
of its EHS risks.
16. EHS policy: overall intentions and direction of the company related to EHS performance
as expressed by the Board of Directors
EHS MANUAL
4.0 Context of the Winthrox Laboratories Pvt. Ltd
4.1 Understanding the Winthrox Laboratories Pvt. Ltd and Its Context
Winthrox Laboratories Pvt. Ltd contexts related to internal & external issues that are relevant
and can affect its ability to achieve intended results of the EHSMS are identified and
documented by the respective departments with proposed actions. Information about these
external and internal issues are regularly monitored and reviewed.
Moral – Winthrox Laboratories Pvt. Ltd believes in the Principle of ‘All workers have a right to
work in places where risks to their health and safety and adverse environmental impact are
properly controlled. Environmental Health and safety is about stopping workers getting hurt at
work or ill through work and impact of environment/ economic losses.’
Legal – There is a wealth of health and safety legislation and codes of practice covering work
both within offices and manufacturing sites. Without a formal system in place it is difficult for
Winthrox Laboratories Pvt. Ltd s to ensure that they understand and meet all their legal
obligations.
Financial – In many cases there is often no conflict between what is good for business and what
is good for health and safety management. Improved health and safety performance leads to
increased productivity, reduced insurance premiums, improved morale and increases the
company’s chances of winning new business.
Winthrox Laboratories Pvt. Ltd determines the external and internal issues that are relevant to its
purpose and strategic direction and that affect its ability to achieve the intended results of the
EHSMS. Consideration is given to the:
1. Positive and negative factors or conditions.

2. External context and issues, such as legal, regulatory, technological, competitive,
cultural, social, political and economic environments.
3. Internal context and issues, such as values, culture, Winthrox Laboratories Pvt. Ltd
structure, knowledge and performance of the business.
4. Determination and requirements of the needs and expectations of interested parties
relevant to the EHSMS.
5. Authority and ability to exercise control and influence.
6. Activities, products and services relevant to the business.
7. Documented information is retained as evidence to support that the context of the
Winthrox Laboratories Pvt. Ltd has been taken into account in the EHSMS.
EHS MANUAL
4.2 Understanding the Needs and Expectations of Interested Parties
The interested parties for Winthrox Laboratories Pvt. Ltd include Clients, vendor/Service
Providers, Employees, Management, Government (DRAP)/Regulatory bodies. The needs and
expectations of interested parties are identified and taken care by the departments. Management
of Winthrox Laboratories Pvt. Ltd is always committed to fulfill the needs and expectations of all
interested parties. All workers have an expectation that neither their health nor their safety will
be at risk as a result of their employment with Winthrox Laboratories Pvt. Ltd. The main needs
and expectations of the interested parties are given below.
S.No Interested Parties Needs and expectations of the Interested Parties

Clients/ EHSMS 1 A simple solution that manages compliance easier.
2 Implementation of the product in-line with EHSMS and
Regulatory requirements
3 Receive responsive support
4 Delivery of free content to educate around compliance
Suppliers / Principals & 1.Good relationship.
Service Providers 2.On-going and secure workplace.
3.To be paid on time.
4.Clear understanding of requirements.
5.Constructive feedback.
6.Want to provide services/products to a reliable, reputable
and financially viable business
Employees 1.Job security.
2.Salary for work performed.
3.Flexible work hours.
4.Clear understanding of their role and responsibilities.
5.Able to raise issues of concern and provide constructive
feedback.
6. Good, friendly and safe work environment.
7. To feel valued and appreciated.
8. Opportunities for personal development.
Top Management/ Owners/ 1. Have a growing business that provides profit.
Shareholders 2.Be well governed and well managed.
3. Want staff to enjoy their work, be challenged, perform
their job competently and meet the company, regulatory and
EHSMS Requirement
Government/DRAP & 1. Follow the rules & regulations laid down by the
Regulatory Bodies Government and Public authorities and meeting the Legal
requirements.
2. To submit all tax obligations accurately and on time.
EHS MANUAL
3. To maintain high standards of corporate governance.
Visitors 1. Environment friendly workshop design with no emissions.
2. Good, friendly and safe work environment.
Community i.e. society at 1. Good corporate citizen.
large 2.Diversity of employees
4.3 Scope of the Environmental Health and Safety Management System
The scope of this Environmental Health & Safety System covers all work related to Winthrox
Laboratories Pvt. Ltd and any associated administration and any Winthrox Laboratories Pvt. Ltd
activities on site. Scope of the Environmental Health and Safety Management System is as
follows:
This Policy is applicable in the entire Winthrox Laboratories Pvt. Ltd all operation and distribution
operation. It is the aim of Winthrox Laboratories Pvt. Ltd to have a seamless environmental health and
safety, environment that takes into account economic and ecological considerations in equal measure.
4.4. Environmental Health and Safety Management System and its Processes
Winthrox Laboratories Pvt. Ltd EHS System has been based on the format of the new
International Standard ISO 45001 and ISO 14001. Processes for Winthrox Laboratories Pvt. Ltd
with inputs, outputs and sequences .Processes include:
i) Trading of items (Procurement from Agents)
ii) Repair & refurbishment of static & rotating equipment at Workshop
iii) IT work (Maintenance of systems & support of software and hardware for departments)
iv) HR & Administration ( Recruitments & Recording employee attendance, Leaves, Plan for
training and renewal of licenses)
Necessary resources for the processes are provided by the management through HR and their
responsibilities & authorities are defined and documented. Risks and opportunities for each
process are determined and necessary actions are planned to enhance desirable effects and
eliminate/reduce undesired effects. Consists of the following levels of documented information:
1. Policies: Policies are documents that demonstrate the overall commitment to improving
quality/EHS performance and are authorized by the Management Team.
2. System procedures: High-level procedures that define the activities that are to be
fulfilled to ensure that the EHS that complies with standards.
3. Module workflows, operational procedures and work instructions. Control and
operational procedures:
4. Meet EHS requirements.
5. Provide supplementary guidance and instructions to support the intent of the EHS.
6. Ensure that the requirements of the EHS will be adequately addressed within the
organization.
EHS MANUAL
7. Forms, registers and records are evidence to prove the EHS is operational.
5.0 Leadership
5.1 Leadership & Commitment: General
Management of Winthrox Laboratories Pvt. Ltd demonstrates its leadership & commitment with
respect to Environmental Health and Safety Management System, through:
i) Assigning responsibility and accountability for effectiveness of the EHSMS.

ii) Taking overall responsibility for the prevention of work-related injury and ill health and
provision of safe and healthy workplaces and activities.
iii) Protecting workers from reprisals when reporting incidents, hazards, risks and opportunities.
iv) Ensuring the organization establishes and implements a process for consultation and
participation of workers.
v) Supporting the establishment and functioning of a Environmental Health and Safety
Committee.
vi) Ensuring that Environmental Health and Safety Policy & Environmental Health and Safety
Objectives are established and are compatible with strategic direction of the organization.
vii) Ensuring that resources needed for the EHSMS are available.
viii) Communicating on importance of effective EHSMS to all concerned. Guiding and
supporting personnel to contribute to the effectiveness of EHSMS.
ix) Promoting Risk Based and Process approach.
x) Promoting improvements
xi) Ensuring that EHSMS achieves its intended results by periodic review.
Organizational roles, responsibilities and authorities.
Responsibilities and authorities are defined in Job Descriptions. These are communicated to the
relevant functions. Organization Chart for Winthrox Laboratories Pvt. Ltd showing the authority
and hierarchy of various roles.
EHS Manager
The EHS Manager has responsibility and authority for:
1. Ensuring that the:
2. EHSMS is established, implemented and maintained in accordance with the requirements

of ISO 45001 and ISO 14001
3. EHSMS processes are delivering their intended outputs.
4. Reporting performance of the EHSMS and opportunity for improvements to the
management.
EHS MANUAL
5. Integrity of the EHSMS is maintained when changes to the EHSMS are planned and
implemented.
6. Reporting on the performance of the EHSMS to top management for review and as a
basis for improvement.
5.4 Consultation and Participation of Workers
Consultation and participation of workers is carried out through the EHSMS Committee. The
following events may be used to facilitate participation:
Toolbox Meeting
1. The safety Manager will chair and take minutes of toolbox meetings.
2. The frequency of toolbox meetings is determined by the:
3. All machine operators on the site at the time of the meeting MUST attend unless excused
by the EHS/Plant Manager for an extraordinary reason.
4. The Safety Manager or his representative will record
5. Names of all attendees
6. Concerns or hazards raised regarding machine
7. Accident report
8. A brief summary of specific topics covered or instructions given
9. Completed site safety toolbox meeting records shall be held in Toolbox record.
EHSMS Meeting
1. The Environmental Health and Safety Meeting is made up of representatives from all
levels within the organization. The meeting can be a committee or it can be a full company
meeting.
2. The meetings will be minuted with action points clearly identifying responsibility with
target date for completion. The following items will be discussed:
3. Previous minutes and actions taken
4. Reviews of policies
5. Correspondence, i.e. new laws and legislative requirements
6. Objectives achieved
7. Hazards/risk
8. New equipment and new work processes (including hazards associated with new
equipment or processes)
9. Training undertaken and training for next period
10. Accidents and incidents
EHS MANUAL
11. Upcoming and overdue events
12. Changes that affect workplace safety
13. General business Excellence
14. Environmental impact (Water, Energy consumption and waste material deposition)
Appointment of Employee Health and Safety Coordinators
If required annual nominations will be asked from employees for representatives/ Coordinators to be
elected. If more nominations are received for the positions available, an election will be held by ballot.
Trained representatives have the following duties as outlined in the responsibilities section.
6.0 Planning
6.1 Addressing Risks and opportunities
6.1.1 GENERAL
The following have been considered in the development of the EHSMS:
1. Hazards.
2. EHS risks and other risks.
3. EHS opportunities and other opportunities.
4. Legal and other requirements
All Department heads have identified risks for individual processes and controls are developed
for all the identified risks. The risks and the issues are addressed with a view to
 Enhance Desirable Effects

 Reduce Or Prevent Undesired Effects
 Achieve Improvements
The control actions are implemented considering potential impact on the conformity of products
and services. Actions taken to address the risks and issues are regularly monitored by EHS
Manager & Department Heads for strict implementation. The risks, issues and the controls
thereof are maintained as Documented Information by the department heads. Opportunities for
achieving desired improvements are identified by the Department heads and implemented to the
extent possible. The results of such implementations are reviewed and achieved improvements
are assessed.
EHS MANUAL
6.1.2 Hazard identification and assessment of risks and opportunities
6.1.2.1 Hazard Identification
The organization has established, implement and maintain a process for the on-going proactive
identification of hazards arising. The process has taken into account but not limited to:
1. Routine and non-routine activities and situations, including consideration of

Infrastructure, equipment, materials, substances and the physical conditions of the
workplace;
2. Hazards that arise as a result of product design including during research, development,
testing, production, assembly, construction, service delivery, maintenance or disposal;
3. Human factors;
4. How the work is actually done;
5. Emergency situations;
6. People, including consideration of those with access to the workplace and their activities,
including workers, employs, contractors, visitors and other persons;
7. Those in the vicinity of the workplace that can be affected by the activities of the
organization;
8. Workers at a location not under the direct control of the organization;
9. The design of work areas, processes, installations, machinery/equipment, operating
procedures and work organization, including their adaptation to human capabilities;
10. Situations occurring in the vicinity of the workplace caused by work-related activities
under the control of the organization;
11. Situations not controlled by the organization and occurring in the vicinity of the
workplace that can cause work-related injury and ill health to persons in the workplace and
adverse environmental impact;
12. Actual or proposed changes in the organization, its operations, processes, activities and
Environmental Health and Safety Management System;
13. Changes in knowledge of, and information about, hazards;
14. Past incidents, internal or external to the organization, including emergencies, and their
causes;
15. How work is organized and social factors, including workload, work hours, leadership
and the culture in the organization.
16. Contamination of water source, excessive energy lost and waste deposition.
EHS MANUAL
6.1.2.2 Assessment of EHSMS Risks and Other Risks to the EHSMS Management System
The organization has established implemented and maintained processes to:
1. Assess EHSMS risks from the identified hazards taking into account applicable legal
requirements and other requirements and the effectiveness of existing controls;
2. Identify and assess the risks related to the establishment, implementation, operation and
maintenance of the EHSMS management system that can occur from the issues identified in
the organization context and the needs and expectations of the interest parties.
3. The organization’s methodology and criteria for assessment of EHSMS risks is defined
with respect to scope, nature and timing, to ensure it is proactive rather than reactive and
used in a systematic way. These methodologies and criteria is maintained and retained as
documented information.
6.1.2.3 Identification of EHS Opportunities and Other Opportunities
The organization has established implemented and maintained processes to identify:
1. Opportunities to enhance EHSMS performance taking into account planned changes to

the organization and its processes or its activities;
2. Opportunities to eliminate or reduce EHSMS risks;
3. Opportunities to adapt work, work organization and work environment to workers;
4. Opportunities for improving the EHSMS.
6.1.3 Determination of Legal and other Requirements
The organization has:
1. Determined and has access to the up to date legal requirements to which the organization
subscribes / compliance obligations related to its Hazards and EHSMS risk;
2. Determined how these legal and other requirements / compliance obligations apply to the
organization and what needs to be communicated;
3. Take these legal and other requirements / compliance obligations into account when
establishing, implementing, maintaining and continually improving its EHSMS.
4. The organization has maintained documented information of its applicable legal and
other requirements / compliance obligations and has ensure that it is updated to reflect any
changes.
EHS MANUAL
6.1.4 Planning Action
The organization has planned to take actions to address its:
1. Significant environmental aspects, and address these risks and opportunities;

2. Compliance obligations / applicable legal and other requirements;
3. Risks and opportunities;
4. Integrate and implement the actions into its EHSMS processes or other business
processes;
5. Evaluate the effectiveness of these actions;
The organization has taken into account the hierarchy of controls and outputs from the
Environmental Health And Safety when planning to take action. The organization has considered
its best practices, technological options and its financial, operational and business requirements.
6.2 Environmental Health and Safety Objectives and planning to achieve

them
Environmental Health and Safety objectives for all processes are defined and are available with
the respective department heads. These are consistent with the Environmental Health and Safety
policy and measurable. Environmental Health and Safety Objectives are defined with focus on to
maintain and improve the Environmental and to achieve continual improvement. Objectives are
monitored and communicated. Documented information of Environmental Health and Safety
Objectives are maintained. Planning for achievements of the Objectives is done covering the
action plan, resources responsibility and time period. EHS Coordinators in consultation with the
Department heads determines fulfilment of the Environmental Health and Safety objectives
periodically and puts forward the results of achievements for Management Review. While
planning how to achieve its Environmental Health and Safety objectives, the organization has
considered;
1. What will be done;

2. What resources will be required;
3. Who will be responsible;
4. When it will be completed;
5. How the results will be evaluated.
6. How it will be measured through indicator (if practicable) and monitored, including
frequency;
7. How the actions to achieve Environmental Health and Safety objectives will be integrated
into the organization’s business processes.
The organization has maintained and retains documented information on Environmental health
and safety objectives and planning to achieve them
EHS MANUAL
7.0 Support
7.1 Resources
Winthrox Laboratories Pvt. Ltd has determined and provides the resources needed for the
establishment, implementation, maintenance and continual improvement of the Environmental
Health And Safety. Resources needed, which include people, infrastructure, environment,
monitoring & measuring resources are determined by the respective Department heads and
approved by the CEO. For determining the resources, capabilities and constraints of internal
resources and required competency are considered. Requirement of personnel and the
infrastructure are identified by departmental heads for effective operation and control of EHSMS
and are approved by the CEO. Personnel could be internal or through external providers.
Infrastructure includes:
 Systems used for planning & recording ( such as SAP) including hardware and software
 Processing and testing equipment at workshop
 information and communication technology
7.2 Competence
Management ensures that the personnel performing work which affects the performance and
effectiveness of the EHS management system and its ability to fulfill its compliance obligation
are competent on the basis of education, training, skills and experience. Where necessary,
training is provided to personnel to acquire necessary competence and the effectiveness is
evaluated. Documented information is maintained as evidence of competence.
7.3 Awareness
Personnel of each department are made aware of Environmental Health and Safety policy, and
objectives for the department and their contribution to effective Environmental Health and Safety
Management System. They are also made aware of:
1. Related actual or potential EHS hazards and risk those are relevant for them.
2. The implications of not conforming to the Environmental Health and Safety management
system requirements, including not fulfilling the organization’s compliance obligations, also
includes the consequences, actual or potential, of their work activities.
3. Information and outcome of the investigation of relevant incidents.
7.4 Communication
7.4.1 Mode of internal and external communications is informed to the personnel by Department
Heads. It includes what to communicate, whom to communicate and when.
EHS MANUAL
7.4.2 Internally communicate information relevant to the Environmental Health and Safety
management system among the various levels and functions of the organization, including
changes to the Environmental Health and Safety management system, as appropriate. Ensure its
communication process enables persons doing work under the organization’s control to
contribute to continual improvement.
7.4.3 Externally communicated information relevant to the Environmental Health and Safety
management system, as established by the organization’s communication process and as required
by its compliance obligations.
7.5 Documented Information
Documented information includes manual, procedures, records, information received or

communicated by e-mail etc. Documented information are maintained as required by the
Environmental Health and Safety Management System and those determined by the organization
for effective operations.
Creating & updating documented information
Following are ensured while creating & updating documented information.
 Identification & description ( title , date, reference no)

 Format is maintained in system or as hard copy.
 Reviewed and approved by authorized person (department head).
Control of documented information
Documented information is controlled so that these are available and suitable for use. Those are
protected from improper use, loss of confidentiality, as applicable .For control of documented
information, following are ensured:
 Approval for adequacy prior to issue

 Distribution to concerned functions.
 Ensuring accessibility and retrieval when required.
 Ensuring storage and preservation
 Version or revision control after changes
 Defining retention period and disposition methods.
 Ensuring that documents of external origin are identified and their distribution controlled.
EHS MANUAL
8.0 Operation
8.1 Operation Planning & Control
8.1.1 General
Operational planning is carried out by Individual departments of Winthrox Laboratories Pvt. Ltd
so that EHSMS requirements are met. The Planning covers:
1. Environmental Health and Safety requirements of product/services to be provided.

2. Processes , documents / documented information and resources needed for the product &
services
3. Verification, inspection and measurement activities as applicable.
4. Acceptance criteria for the products
5. Adapting to work to workers.
6. On multi-employer workplaces, the organization is implemented a process for
coordinating the relevant parts of the EHS management system with other organizations.
The organization has controlled and planned the changes and reviews the consequences of
unintended changes, taking action to mitigate any adverse effects, as necessary. The organization
has ensured that outsourced processes are controlled or influenced. The type and extent of
control or influence to be applied to the process has been defined within the EHS management
system. The organization has maintained documented information to the extent necessary to have
confidence that the processes have been carried out as planned.
8.1.2 Eliminating hazards & Reducing EHSMS Risks
Elimination of hazards and reduction of risks is carried out in line with the following hierarchy
of controls:
1. Eliminate the hazard.

2. Substitute with less hazardous process, operations, materials or equipment.
3. Use engineering controls (guards) and reorganization of work.
4. Use administrative controls, including information, instruction and training.
5. Use adequate PPE.
8.1.3 Management of Change
The organization has established a process for the implementation and control of planned
changes that impact EHSMS performance.
EHS MANUAL
1. New products, services and processes will be reviewed and changes made to the Health
& Safety System as necessary.
2. Changes to work processes, procedures, equipment, or organizational structure will be
reviewed and changes made to the Environmental Health and Safety System as necessary
3. Changes to legal and other requirements will be reviewed and changes made to the
Environmental Health & Safety System as necessary.
4. Changes in knowledge or updated information about hazards and risks will be reviewed
and changes made to the Environmental Health & Safety System as necessary.
5. Changes in technology will be reviewed and changes made to the Environmental Health
& Safety System as necessary.
Winthrox Laboratories Pvt. Ltd has controlled temporary and permanent changes to promote
EHS opportunities and to ensure they do not have an adverse impact on EHS performance. The
organization will review the consequences of unintended changes, taking action to mitigate any
adverse effects, as necessary, including addressing potential opportunities.
8.1.4 Procurement
8.1.4.1 General
Procurement of products and services is carried out in line with the requirements of the
company’s Environmental Health & Safety System. Winthrox Laboratories Pvt. Ltd has
established controls to ensure that the procurement of services conform to its EHS management
system requirements.
1.1.4.2 Contractors
Winthrox Laboratories Pvt. Ltd has established processes to identify and communicate the
hazards and to evaluate and control the EHS risks, arising from the:
1. Contractors’ activities and operations to the organization’s workers;

2. Organization’s activities and operations to the contractors’ workers;
3. Contractors’ activities and operations to other interested parties in the workplace;
4. Contractors’ activities and operations to contractors’ workers.
Winthrox Laboratories Pvt. Ltd has established and maintained processes to ensure that the
requirements of the organization’s EHS management system are met by contractors and their
workers. These processes shall include the EHS criteria for selection of contractors. Suppliers
and Contractors are to:
1. Comply with the requirements of the EHS and participate in EHSMS promotions.
EHS MANUAL
2. Promptly report any unsafe working conditions, faulty equipment, hazards/risks, injuries
or incidents
8.1.4.3 Outsourced processes:
Calibration of equipment is outsourced to external calibration agency. Transportation / delivery

of products are often outsourced if necessary. The performance of the outsourced agencies are
monitored and controlled. Necessary resources for the processes are provided by the
management through HR and their responsibilities & authorities are defined and documented.
Risks and opportunities for each process are determined and necessary actions are planned to
enhance desirable effects and eliminate/reduce undesired effects. The Safety Manager shall
ensure that outsourced processes are consistent with legal and organization requirement so that
EHSMS requirements are met.
8.2 Emergency Preparedness and Response
The organization has established, implemented and maintained the process(s) needed to prepare
for identify and respond to potential emergency situations and maintain a process to prevent or
minimize EHS risks from potential emergencies, including;
1. Preparing to respond by planning actions to prevent or mitigate adverse EHS impacts

from emergency situations;
2. Responding to actual emergency situations;
3. Taking action to prevent or mitigate the consequences of emergency situations,
appropriate to the magnitude of the emergency and the potential environmental impact;
4. Periodically testing the planned response actions, where practicable;
5. Periodically reviewing and revise the process and planned response actions, in particular
after the occurrence of emergency situations or tests;
6. Providing relevant information and training related to emergency preparedness and
response, as appropriate, to relevant interested parties, including persons working under its
control.
7. The establishment of a planned response to emergency situations and including first aid;
8. The periodic testing and exercise of emergency response capability;
9. The evaluation and, as necessary, revision of emergency preparedness processes and
procedures including after testing and in particular after the occurrence of emergency
situations;
10. The communication and provision of relevant information to all workers and at all levels
of the organization on their duties and responsibilities;
11. The provision of training for emergency prevention, first aid, preparedness and response;
12. The communication of relevant information to contractors, visitors, emergency response
services, government authorities, and, as appropriate, the local community.
EHS MANUAL
Winthrox Laboratories Pvt. Ltd has maintained documented information to the extent necessary
to have confidence that the processes are carried out as planned. In all stages of the process the
organization has taken into account the needs and capabilities of all relevant interested parties
and ensures their involvement. The organization has maintained and retains documented
information on the process and on the plans for responding to potential emergency situations.
9.0 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
Winthrox Laboratories Pvt. Ltd has planned and implemented the monitoring, measurement,
analysis and evaluation processes needed:
 Applicable legal requirement and other requirements;

 Its activities and operations related to identified hazards and EHSMS risks and
opportunities;
 To continually improve the effectiveness of the Environmental Health and Safety
Management Systems.
 Operational Controls;
 Winthrox Laboratories Pvt. Ltd’s EHSMS Objectives;
Winthrox Laboratories Pvt. Ltd has determined:
1. The criteria against which the organization will evaluate its EHSMS performance;
2. The methods for monitoring, measurement, analysis and evaluation, as applicable, needed
to ensure valid results;
3. When the monitoring and measuring shall be performed;
4. When the results from monitoring and measurement shall be analyzed and evaluated and
communicated.
Winthrox Laboratories Pvt. Ltd has evaluated the performance and the effectiveness of the EHS
management system. The organization has retained appropriate documented information as
evidence of the monitoring, measurement, analysis and evaluation results. The organization has
ensured, as applicable that calibrated or verified monitoring and measurement equipment is used
and maintained, as appropriate. The organization is communicating relevant environmental
performance information both internally and externally, as identified in its communication
processes and as required by its compliance obligations. The organization has retained
appropriate documented information as evidence of the monitoring, measurement, analysis and
evaluation results.
EHS MANUAL
9.1.2 Evaluation of Compliance
Once the application of a particular requirement has been defined, the means of how compliance
to the requirement is going to be ensured is to be established by the company, in consultation
with appropriate personnel. Various means of ensuring compliance are available and include, but
are not limited to the following:
1. Policies and/or procedures being established documented and implemented.

2. Training being provided.
3. Engineered solutions being implemented.
4. Instructional signs being displayed.
Details of the means of ensuring compliance are to be entered into the Legal and Other
Requirements.
Means of Verifying Compliance
1. Once the means of ensuring compliance has been determined, the means of how
compliance to each requirement is to be verified on a continuous basis is to be established
by the Winthrox Laboratories Pvt. Ltd, in consultation with appropriate personnel.
2. Various means of verifying compliance are available and include, but are not limited to
the following:
3. Internal auditing. (To verify compliance to the corresponding policies and/or procedures).
4. Periodic workplace inspections
5. Periodic review of records.
9.2 Internal audit
Winthrox Laboratories Pvt. Ltd conducts internal audits at planned intervals to determine the
Environmental Health and Safety Management System conforms to the planned arrangements, to
the requirements of ISO 45001 and ISO 14001 and to the Environmental Health and Safety
Management System requirements including EHS policy and objective established by the
Organization, and that it is effectively implemented and maintained.
An audit program is planned, taking into consideration the status and importance of the processes
and areas to be audited, as well as the results of previous audits. The audit criteria, scope,
frequency, consultation and methods are defined through documented procedures and relevant
records. Selection of Competent auditors and conduct of audits ensure objectivity and
impartiality of the audit process. Auditors do not audit their own work.
EHS MANUAL
The responsibilities and requirements for planning and conducting audits, and for reporting
results and retaining documented information are defined in a documented procedure. The
management responsible for the area being audited ensures that corrections and corrective
actions are taken without undue delay to eliminate detected nonconformities and their causes and
continually improve its EHSMS performance. Follow-up activities include the verification of
actions taken and the reporting of verification results.
Documented information is retained by Management Representative as evidence of

implementation of audit programs and audit results. Results of internal audits are reported to the
higher management in review meetings.
9.3 Management Review
Top management of Winthrox Laboratories Pvt. Ltd reviews the Organization’s Environmental
Health and Safety Management System annually, to ensure its continuing suitability, adequacy,
and effectiveness. This review includes assessing opportunities for improvement and the need for
changes to the Environmental Health and Safety Management System, including the quality
policy and quality objectives.
The inputs to management review shall include information on
 Status of actions from previous management review

 The needs and expectation of interested parties, including compliance obligations /
applicable legal requirements and other requirements.
 External & internal issues and their changes
 Hazards, EHS Risk and opportunities.
 Performance & effectiveness of the EHSMS, covering :
 Extent to which EHS objectives are met
 Process performance & conformity of products & services
 Non-conformities and corrective actions
 Monitoring & measurement results
 Results of audits (internal & external)
 Performance of external providers.
 Adequacy of resources
 Effectiveness of the actions taken on risks & opportunities
 Fulfillment of its compliance obligations / results of evaluation of compliance
 Opportunities for improvement
EHS MANUAL
The output from the management review will include any decisions and actions related to
 Opportunities for improvement ,

 Any need for changes to the EHSMS
 resource needs
Management Review minutes are generated as documented information and distributed to all
concerned for review and necessary actions.
10. Improvement
10.1 General
Management of Winthrox Laboratories Pvt. Ltd determines opportunities for improvements and
implements necessary actions thereof. These include:
1. Improvement in the products & services for meeting the requirements effectively and also
considering future needs and expectations.
2. Implementing corrective actions and preventive measures to eliminate or reduce
undesired effects.
3. Improving performance and effectiveness of Environmental Health and Safety
Management System.
10.2 Incident, Nonconformity and Corrective Action
Winthrox Laboratories Pvt. Ltd has planned, established, implemented and maintain a process to
manage incidents and nonconformities including reporting, investigating and taking action, when
an incident or a nonconformity occurs, including any arising from complaints, the organization
shall:
1. React in a timely manner to the nonconformity and, as applicable:

2. Take action to control and correct it;
3. Deal with the consequences;
4. Evaluate with the participation of workers and the involvement of other relevant
interested parties, the need for action to eliminate the cause(s) of the incident or
nonconformity, in order that it does not recur or occur elsewhere, by:
5. Reviewing and analyzing the incident or nonconformity;
6. Determining the causes of the incident or nonconformity;
7. Determining if similar incident or nonconformities exist, or could potentially occur;
8. Review the assessment of EHS risk as appropriate.
EHS MANUAL
9. Determine and implement any action needed, including corrective action, in accordance
with the hierarchy of controls and the management of change.
10. Review the effectiveness of any corrective action taken;
11. Update risks and opportunities determined during planning, if necessary;
12. Make changes to the EHS management system, if necessary.
Corrective actions shall be appropriate to the significance of effects or potential effects of the
incidents or nonconformities encountered including environmental impact(s).
Winthrox Laboratories Pvt. Ltd has retained documented information as evidence of:
1. The nature of the incidents or nonconformities and any subsequent actions taken.
2. The results of any corrective action, including the effectiveness of the actions taken.
Winthrox Laboratories Pvt. Ltd will communicate this documented information to relevant
workers, and where they exist, workers’ representatives, and relevant interested parties.
10.3 Continual Improvement
The organization has continually improved the suitability, adequacy and effectiveness of the
EHS management system to.
1. Prevent occurrence of incidents and nonconformities;

2. Promote a positive environmental health and safety culture;
3. Enhance EHSMS performance.
Winthrox Laboratories Pvt. Ltd has ensured the participation of workers, as appropriate, in the
implementation of its continual improvement objectives. The organization has considered the
results of analysis and evaluation, and the outputs from management review, to determine if
there are needs or opportunities that shall be addressed as part of continual improvement.
EHS MANUAL
General (Detailed)
Environmental Health and Safety Roles

The following employees have specific roles and responsibilities relating to
environmental health and safety. Together, they form the Environmental Health and Safety
Committee, which includes a representative from different department:
Title Duties Title Duties
EHS Manager  Ensure that the Environmental Health and Safety Management
System (EHSMS) processes are implemented and maintained in
compliance with the framework of the national laws and regulations
and other regulatory requirements.
Report to Management on the performance of the EHSMS.
Monitor, measure, and analyze the performance of the implemented
management system and identify the need for further improvements.
Liaison with external parties on matters relating to the EHSMS
Plan and manage Environmental Health and Safety internal audits.
Maintain and update the EHSMS Manual in coordination with the
Environmental Health and Safety committee.
Identify EHSMS training needs of employees and laboratory
supervisors
Conduct toolbox talks and trainings for health and safety best
practices
Coordinate evacuation exercises to ensure that all staff become
familiar with these procedures
Assist with the formulation of emergency/contingency plans
Post appropriate warning signs and notices
 Supervise employees to ensure hazards are managed
EHS Coordinator
 Carry out quarterly inspections
 Supervise visitors and contractors
 Train employees in induction on the safe work procedures
 Ensure that any hazardous condition, deficiencies, interruptions or
injuries are reported immediately and well controlled
 Complete Incident Register
 Assist with accident investigations if required
EHS MANUAL
First Aider Ensure the availability of first aid facility
Monitor the first aid items and ensure that the expiry is valid
Provide first aid to employees whenever required
Maintain the first aid register for all first aid cases
Inform EHS Manager/ Officer if any hospitalization is required
Maintain the first aid box replenishment list
Coordinate with Office of Medical Services for medical emergencies
Fire Marshall Ensure the availability of first fighting equipment as per the legal
requirements
Ensure all flammable items have been stored as per manufacturer

recommendations
Determine the nature of fire and act accordingly
Use appropriate firefighting equipment to stop the fire in case of small

fires
In case of major fires contact emergency responders for external

assistance
Inform EHS Manager/ Officer if any hospitalization is required
Record all fire incidents
Ensure all firefighting equipment have been inspected at least once

every six months
Conduct fire emergency mock drill to evaluate the effectiveness of fire

emergency plan in coordination with EHS Manager/ Officer
Emergency Coordinator  Identify the potential emergency situations that can happen at
Winthrox Laboratories in coordination with Environmental Health
and Safety Committee
 Establish emergency response plan for all the emergency situations
at Winthrox Laboratories
 Ensure that the emergency response plan has been communicated to
EHS MANUAL
all staff
 Ensure that emergency contact numbers have been displayed at all
relevant areas within Winthrox Laboratories premises
 Ensure that appropriate notifications shall be made during
emergencies
 Contact external agencies for assistance during emergency situation
 Ensure that the whole campus has been evacuated and all personnel
have been assembled at assembly point during emergencies
 Assist external agencies during emergencies
 Prepare report for all emergencies and report to EHS Manager/
Officer
Medical Officer Provide medical services to employees as far as are reasonably

practicable, during accidents and emergencies and regular checkups.
 Arrange for medical surveillance of employees who are working

under hazardous conditions, where this is deemed necessary
Emergency Response Team  EHS Manager  First Aiders

 Medical Officer  Fire Marshalls
 EHS Coordinators  Emergency Coordinators
 Designated Security Guards
Winthrox Laboratories Pvt. Ltd expects employees to adhere to health and safety regulations in
the following manner:
Staff Members
A staff member has the following responsibilities:
 To take reasonable care while at work for his/her own health and safety and for that of persons
who may be affected by his/her acts or omissions at work
 To cooperate with Winthrox management on safety matters
 Not to misuse or damage safety equipment provided by Winthrox Laboratories
Staff Members (Workers)
Winthrox Laboratories expects from workers a general duty of care and in practice. It is
important therefore to ensure that:
Workers abide by the general safety rules and instructions provided by Winthrox Laboratories
EHS MANUAL
Workers are given full instructions on safety matters relating to the normal functioning in areas
and asked to follow these instructions
Workers are required to report on any accidents or any potentially hazardous condition observed
which could pose danger to personnel and property
Workers should refrain from all acts that could be the cause of danger to personnel and property
Health and Safety Competence, Training and Awareness
Winthrox Laboratories ensures that personnel performing manufacturing, laboratory, packaging
and warehouse works are competent based on appropriate education, training, skills and
experience. The management ensures this through proper recruitment of the most appropriate
personnel for the required jobs.
The EHS Manager/ Officer along with Director, and Managers are responsible for identifying the
training needs of their employees, and for planning and implementing suitable training programs.
The training needs analysis will be carried out before the starting of any new process and all
identified / highlighted trainings related to the following:
EHS Management System
• EHS roles and responsibilities
• Legal Requirements
• Risk/ Impact Management
• EHS Incident history
• EHS performance
• EHS Inductions
• Emergency response and management
• High Risk or Impact tasks / areas
• Specific role, task, or subject requirement (First aiders, working at heights, manual handling,
pharmaceutical lab supervisors, technicians, Lab Instructors, etc…)
Winthrox Laboratories shall ensure that individual training needs shall be reviewed regularly and
recorded on training plan. While developing the training plan for identified training needs,
Winthrox Laboratories will ensure the capabilities of each individual, literacy level and spoken
languages. The trainings will be prioritized keeping in view of factors like legal/manufacturing
requirement, high risk activity, new employee etc.
EHS MANUAL
Winthrox Laboratories will conduct the in-house trainings and ensure that the trainer is qualified
and competitive to deliver the trainings in such a way that is effective. The external training will
be arranged by Winthrox Laboratories where trainer competency is not available in-house.
EHS induction training shall be provided to all new employees or for employees who are put into
new jobs; by the Environmental Health and Safety Committee. During the induction period the
trainer is responsible for ensuring that the level of supervision of the employee is increased to
ensure the level of work conformance and service quality is maintained. At the end of the
induction training, the trainer communicates his/her notes about the new employee performance
to his/her functional manager.
All trainings carried out shall be evaluated for effectiveness. The methods used to verify the
effectiveness of trainings by tracking the development of employee knowledge, learning being
applied to work or not, identifying further gaps for future training needs. The effectiveness of
training can also be monitored by verifying the efficiency of the process/ employee. As part of
training effectiveness, the training feedback shall also be taken from the employees to improve
the trainings’ plan.
Refresher trainings shall be arranged as and when required for employees, as per the legal
requirements.
All records of education, training, skills and experience shall be maintained in the personnel files
of the employees and in training record files maintained by the Office of Human Resources.
Winthrox Laboratories also ensures that all individuals who work in a laboratory are adequately
informed about the physical and health hazards present in the laboratory, the known risks, and
what to do if an accident occurs. The laboratory supervisor must be trained for safe handling,
storage, and disposal of hazardous chemicals found in the laboratory. He/she must also be aware
of emergency procedures and personal protective equipment to be used by the employee while
working in the laboratory.
Environmental Health and Safety Risk Management
Environmental Health and Safety Risk Management is a continuous process and a vital part of
Winthrox Laboratories processes. It shall be carried out for all activities of Winthrox
Laboratories including outsourced activities. Consultation with employees are conducted to
ensure protection of health and safety measures at every stage of the health and safety risk
management process.
EHS risk assessment is an ongoing process and shall be undertaken at various times including:
• When planning or making a change to a work procedures and/or practices;
• When introducing new plant, equipment, materials or substances into the workplace;
EHS MANUAL
• After an EHS incident (including near misses);
• Introduction of new workers;
• Presence of a high level of risk associated with a specific work activity (e.g. confined space);
• At regular or scheduled intervals appropriate to the nature of the workplace and the hazards
present;
• When legislative obligations change (including regulations).
Any condition with the potential to cause illness, injury or death shall be identified as a Hazard
and the records for the same shall be maintained in the Risk Assessment. Safety Review for labs
shall be done on a regular basis by the assigned EHS Coordinator.
Risk Assessment Process
Risk assessment process is divided into 5 systematic steps as follows:
1. Identify Hazards, based on experience, recorded data and other information;
2. Identify who can be harmed or what can be damaged and how – understand who can be
harmed or what can be damaged from the risk and to what extent;
3. Evaluate the Risk and Control Measures by using a recognized method, evaluate the level of
risk / impact and decide if this needs to implement control measures;
4. Implement the Selected Control Measure(s) in the workplace; and
5. Monitor the Control Measures to ensure that they are working correctly to control the risks /
impacts and that no other risks / impacts have been introduced.
Environmental Health and Safety Risk Identification
The comprehensive list of identified EHS hazards will identify the list of who can be harmed,
what can be damaged and how such as:
• Employees;
• Contractors;
• Visitors;
• Entities;
• Facilities/equipment/property damage;
A standard list of all risk sources associated with Environmental Health and Safety must be
developed using the Standard Risk Register (Refer to Appendix A), be reviewed and amended on
regular basis; at least 2 times during the academic year.
EHS MANUAL
Environmental Health and Safety Risk Assessment
Once all types of risks are identified/ amended in the risk register, EHS Manager/ Officer shall
conduct a proper assessment of each risk element arising from Winthrox Laboratories processes
and activities to enable deciding relevant control measures. Using a quantifiable risk assessment
model, the final assessment of the risk is conducted based on the consequences of related
incidents and the likelihood that those consequences may occur.
While analyzing the consequences and likelihood of each risk source, the Health and Safety
Committee refers to sources such as past incidents records, practices, experience, published
literature, internal or external audit reports, specialist/ expert judgments, multi-disciplinary
groups of experts, individual evaluation, or any other relevant techniques.
The population at risk should be identified, which might include owners, staff, clients, visitors,
contractors or suppliers.
To quantify the risk assessment process, the following formula is used:
Risk = Consequence Rating X Probability Rating
Probability of Occurrence
The probability of incident occurrence shall be estimated on a scale from 1 to 5, with 1 being
very unlikely to occur, and 5 being very likely to occur, as explained in the Risk Occurrence
Guidelines (Refer to Appendix B: Risk Occurrence Rating Guidelines). This provides a
quantitative assessment methodology that involves the likelihood ratings with descriptions for
estimating the likelihood of each occurrence.
Risk Consequence Rating
A quantitative assessment of the impact of each risk source shall be determined on a scale from 1
to 5 as well, with 1 being insignificant, and 5 being catastrophic, using the Risk Consequence
Rating Guidelines (Refer to Appendix C: Risk Consequence Rating Guidelines). This will help
assigning a relevant score to best reflect the magnificence, and thus importance, of the impact of
related incidents.
Environmental Health and Safety Risk Rating Stage
Once the probability of occurrence and the consequences of risks are identified, an exact rating
should be assigned to each risk source. This rating helps to better classify the risk in a manner
that enables deciding the relevant control measures and necessary activities to mitigate the risk;
thereby reflecting a transparent and consistent methodology of assessment. The Risk Assessment
Matrix is used to calculate and assign a relative total risk rating using the results of individual
assessment of the probability of occurrence and the consequence rating. (Refer to Appendix D:
Risk Assessment Matrix).
EHS MANUAL
After assigning the relative the total relative risk rating for each risk source, this value is used to
classify each risk source into any of the following categories: extreme risk, high risk, moderate
risk, and low risk. A standard table is used to help classifying each risk source into any of these
categories (Refer to Appendix E: Risk Classification Guide).
Control Measures
The selected control measures and activities should meet all legal and regulatory requirements,
be effective in reducing the risk, cost-beneficial, applicable and reasonably practicable.
The Environmental Health and Safety Committee shall specifically describe the precautions
needed and what aids must be used, in consideration with those already in place.
For each risk, one of the following approaches/ techniques should be selected to address it:
 Avoid – eliminate the threat by eliminating the root cause of the risk (if possible).
 Mitigate – Identify controls to reduce the probability or the impact of the risk.
 Transfer – Make another party responsible for the risk (buy insurance, outsourcing, etc.).
 Accept – Nothing will be done.
Environmental Health and Safety Risk Monitoring
1.7.1 The EHS Committee shall undertake the role of conducting regular review and evaluation
of risk incidents as applicable to EHS.
1.7.2 The EHS Committee holds planned meetings at least 2 times during the academic year; to
conduct the following tasks:
a) Update the pre-defined risk register; by adding new risk sources, removing existing risk
sources which are deemed discontinued/ irrelevant, or modifying the details of existing risk
sources.
b) Re-assess the different risk sources as pre-defined in the Risk Register, in terms of probability
of occurrence or consequence scoring.
c) Review the risk incidents during the past period.
d) Ensure that the control measures in place are still relevant to control the risk.
e) Discuss further controls as deemed necessary.
1.7.3 In addition to the planned/ regular meetings, unplanned meetings can be also held after
certain situations giving rise to the need to review the risk assessments, which might include any
of the following:
a) Whenever key operational circumstances affecting the work environment change.
b) After an incident where investigation identifies a major/ key risk source.
EHS MANUAL
c) After an inspection or audit report where additional key risks are identified.
d) After an emergency situation.
e) When new key processes or business activities are adopted.
Manager/ Officer of Health and Safety Risk Reporting
A comprehensive report on EHS risk management shall be submitted by the EHS Committee
following each planned or unplanned meeting. The report shall be submitted by the EHS
Manager/ Officer to the Chief Operating Officer (COO).
The report should include, but not limited to, the following key components:
a) An updated version of the Risk Register that shows different risk sources with a clear
description, assessment and recommended control measures.
b) A detailed clarification of any newly identified risk sources/ factors, as well as any irrelevant/
discontinued risk factors as deemed to be removed from the risk register, along with full
explanation and reasoning of each.
c) Explanation of any newly recommended control measures that aim to mitigate any of the
identified risk sources, including concrete action plans to address such measures with a clear
timeframe.
d) Any additional resources needed to conduct such actions and control measures.
e) Parties and/or individuals responsible to achieve the plans.
Laboratories
The following measures need to be followed at all times by laboratory users:
Do not prepare, store, or consume food or beverages in the laboratory.
• Wear personal protective equipment (PPEs) as required for each activity.
• Refrain from smoking in the laboratory.
• Always know the physical and chemical hazards associated with the materials that are being
utilized in the lab.
• Be familiar with the Material Safety Datasheet (MSDS) of chemicals and substances in use.
• Always wear appropriate protective clothing. Cover dress with a suitable lab coat or apron
when handling liquids.
• Always wash hands with soap and water after using chemicals. This applies even if you have
been wearing gloves.
• Never perform any hazardous work without supervision.
EHS MANUAL
• Never perform unauthorized work, preparations or experiments.
• Be familiar with the location of emergency equipment - fire alarm, emergency eye wash,
emergency power off, emergency telephones, emergency exits, and emergency response team
contacts.
• Use equipment and hazardous chemicals only for their intended purposes.
• Use a fume cupboard whenever there is a possibility of poisonous or irritating fumes being
emitted from the chemicals being utilized.
• Never leave an experiment unattended with power supply switched ON.
• Keep equipment back from the edge of the lab bench.
• Read all labels on chemicals carefully before using them in the lab.
• Report any accident, however minor, immediately.
• Laboratory water sources should not be used for drinking.
• If you notice a problem that may cause a hazard, immediately notify the laboratory supervisor.
• Store chemicals and equipment in their intended storage areas.
• Store flammable chemicals separately.
• Avoid storing dangerous materials in containers resembling to those of foodstuff.
• Store very poisonous materials at closed places.
• All containers have to be labeled indicating the name and properties of the chemicals inside.
• Ensure medical, chemical, biological, and regular waste segregation and disposal.
• Warrant proper ventilation in laboratories to ensure that air is continuously replaced and that
concentrations of toxic substances do not increase during the workday. Additionally, the
ventilation system should ensure that the toxic substances are not re-circulated from laboratory to
laboratory or within the building.
Electrical Safety
Most electrically related fires are caused by misuse and poor maintenance of electrical apparatus,
and overloaded circuits and extension cords. The following measures must be followed by the
maintenance team in order to minimize the risk due to electrical hazards:
• Routinely check electrical apparatus and wiring.
• Replace all worn, old or damaged apparatus wires immediately.
• Do not plug multiple extension cords into another.
EHS MANUAL
• Know the capacity of the electrical sockets. Make sure that the amperage of the apparatus being
plugged in does not exceed the rating.
• Extension cords are to be used only when a flexible, temporary connection is necessary - never
for fixed wiring. Where there is a permanent need for an electrical outlet, one should be installed.
• Use the proper personal protective equipment (PPEs) at all times.
Maintenance and House keeping
A major cause of accidents is undoubtedly poor maintenance and, in general, a safe working area
is a tidy area.
• Apparatus and other materials, which are not immediately required, should always be returned
to a safe storage place, and unwanted materials, particularly combustible and flammable items,
should be disposed off safely and promptly.
• Any spillages must be cleaned up immediately by a person who fully appreciates the special
hazards, which the material may possess.
• Flammable and combustible materials must never be stored or left on emergency exit routes or
blocking immediate access to fire alarms, fire equipment or electrical switchgear.
• Gas, water and electricity, and any piped gas or liquid, supplies should always be turned off
when not required, and especially at the end of the working day.
• Dispose of all trash as soon as possible. Do not allow trash to accumulate anywhere.
• All staircases, exits, corridors shall be kept free of all obstructions at all times. No furnishings,
decorations, other combustible or flammable objects shall obstruct exits.
• Do not physically obstruct or block from view fire extinguishers, fire alarm pull stations,
standpipe hose outlets or electrical shut off locations. Do not block or hang anything from
sprinkler heads.
Revision and continual improvement
EHS Officer/ Manager in coordination with Winthrox laboratories Safety Committee shall
review and update safety procedures and measures at Winthrox laboratories twice a year. This
revision shall be part of the environmental Health and Safety Internal Audit process. The
introduced changes shall be communicated to the Winthrox Laboratories Pvt. Ltd through
internal communication channels, emails, awareness sessions, and external communication
channels.
WASTE MANAGEMENT PROCEDURE
EHS MANUAL
This procedure covers the generation, handling, preservation, transport, collection and disposal
of all wastages on Winthrox laboratories’ facilities.
Waste types can be described as mentioned below but not limited to:
▪ Paper
▪ Waste from maintenance activities
▪ Solid wastes
▪ Toner Cartridges and Redundant IT Equipment
▪ Non Hazardous Waste
▪ Hazardous waste
▪ Waste water
▪ Containers and Carry bags
▪ Waste oil, paints & grease
▪ Oil stained waste materials
▪ Biological waste from micro lab
▪ Chemicals and pharmaceutical manufacturing waste
▪ Medical waste
Winthrox laboratories shall observe and comply with the required local legal compliance for the
Waste Management of solid, liquid, recyclable, medical, hazardous and non-hazardous wastes
mentioned.
Procedural steps
• The waste at Winthrox laboratories shall be defined as a substance or object which the firm
intends to discard or required to discard as part of the environmental protection.
• Winthrox laboratories shall identify required domestic legal requirements to minimize, mitigate
the production of wastage which may cause harm to environment/ society.
• The hazardous wastes produced by Winthrox laboratories may include:
 Waste from gases
 Electronic waste
 Chemicals/microbial and pharmaceutical products
 Packaging waste
EHS MANUAL
 Waste oil, paints & grease
 Waste oil / grease stained materials
• All wastes shall be disposed by Winthrox laboratories with the permit or approved waste
disposal agent in accordance with the controlled waste regulations, Fulfill the regulatory
requirements for the carriage of dangerous goods, if applicable.
• Waste handled at Winthrox laboratories shall be identified as Hazardous, Non Hazardous and
appropriate segregation, storage and disposal plan shall be made. Wastes, which can be recycled,
reused, shall be reviewed wherever practicable.
• Waste Disposal shall be through only an approved agency and the extent of control shall be
established and monitored with appropriate records.
Water, Energy Conservation
Winthrox laboratories explore innovative ways to conserve water, reduce energy consumption,
and minimize waste. In particular, Winthrox laboratories requires consistent, high-quality water
for production and wastewater treatment. To meet these challenges, Winthrox laboratories must
question conventional thinking and typical approaches and explore new technologies and
solutions to remain competitive.
Exploring new methods to reduce the cost of treating water, wastewater discharge, and utility
expenses challenges.
Water is used widely during the production of pharmaceutical products as a direct ingredient as
well as indirect uses such as formulation, rinsing, sanitizing and cleaning. Most high quality
makeup water systems used within pharmaceutical production have some element of
recirculation inherent in the system design. When water is not needed, water systems typically go
into a recirculating standby mode to control microbial proliferation within the water and on the
wetted surfaces of the water system. This conventional approach considered the best ‘in situ’
approach for controlling microbial contamination. Often, microbial contamination is the most
difficult, and costly, aspect of the water system design. While chemical and organic impurities
can usually be managed with little difficulty, proliferation of bacteria, viruses and other
organisms can challenge even the best system designs.
In an effort to build robustness into the water systems of a pharmaceutical facility, many of these
systems are built with a 2 x 100% redundancy approach. This ensures the water system is always
available when needed. All water systems require periodic maintenance monitoring and
adjustments, and a redundant water system approach allows one train to be available while the
other train is being serviced or maintained. This redundant water train will continually recirculate
while in the standby mode, and will consume water and electricity, and produce wastewater,
nearly 100% of the time since it is by nature a standby or backup system.
EHS MANUAL
Water Reuse
In an effort to reduce raw water consumption and wastewater production from its product
manufacturing process, this same healthcare products manufacturer implemented a water reuse
system.
The wastewater includes a proprietary organic compound introduced during the manufacturing
process. It is critical to remove this contaminant from the wastewater stream before it can be
returned to the feed of the system for reuse. Additionally, while important to remove the organic
compound, it was also desirable to selectively retain a proprietary inorganic compound in the
wastewater stream. By removing the organic contaminant and leaving the selective inorganic
compound intact, the wastewater stream could be returned to the feed system and used again,
safely and efficiently.
Membrane solutions such as ultrafiltration, reverse osmosis, nano filtration, micro filtration and
ceramic membranes were all considered as possible solutions for this process. Ultimately, nano
filtration was selected because of its process characteristics in removing the organic contaminant
while having minimal impact on the selective inorganic compound in the process.
Appendix A: Standard Risk Register

EHS MANUAL
EHS MANUAL
Appendix C: Risk Consequence Rating Guidelines

Rating Description Financial Human Life/ Business Reputation Strategic
EHS MANUAL
Impact Health Impact Interruption and Image Objectives
(Staff/ Visitors)
1 Insignifican Financial loss No or only Negligible; Negligible Small
t of less than minor personal system, impact on the corruptions that
100000 Rs injury; first aid network or reputation of can be resolved
during the year. is needed but function is the firm that in day-to-day
no days lost. unavailable can be management
for less than disseminated
one hour within the
Winthrox
Laboratories
Pvt. Ltd
2 Minor Minor financial Minor injury; Inconvenient; Adverse local Minor impact
loss of 100000 medical critical media on the
to 500,000Rs; treatment is system, coverage achievement of
which is not needed and network or only. certain strategic
covered by some days are function is goals that can
insurance lost unavailable be avoided by
for several routine
hours. corrections/
remedies.
3 Moderate Medium Injury; possible Client, Adverse Significant
financial loss of hospitalisation student, staff media impact that
500K to 2m Rs and numerous or visitor coverage needs higher
during the year; days lost dissatisfaction within the levels
which is not ; critical emirate. involvement to
covered by system, reflect
insurance network or corrections and
function is remedies.
unavailable
for up to 1
working day.
4 Major Financial loss Single death Critical Adverse and Major impact
of 2m to 5m Rs and/or long- system, extended on the ability to
during the year; term illness or network or national achieve certain
which is not multiple serious function is media strategic goals
covered by injuries. unavailable coverage. or delays the
insurance for several achievement by
days of several months.
outage.
5 Catastrophi Financial loss Group death, Critical Demand for Disastrous
c of above 5m Rs fatal or system government impact that
during the year; permanent unavailable inquiry or prevents the
EHS MANUAL
which is not disability or for more than investigations achievement of
covered by major disease. 1 day or more goals or delays
insurance but during a the target
crucial time. completion
dates by more
than 1 year.
EHS MANUAL
Appendix F: INCIDENT REPORTING FORM

EHS MANUAL

EHS Manual - Final

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

EHS Manual - Final

Uploaded by

Copyright:

Available Formats

WINTHROX LABORATORIES PVT.

A. SIGNATURE AND APPROVAL

2.0. COMMITMENT TO ENVIRONMENTAL HEALTH AND SAFETY

3.0 TERMS & DEFINITIONS.

4.0 CONTEXT OF THE WINTHROX LABORATORIES PVT. LTD

9.0 PERFORMANCE EVALUATION

ENVIRONMENTAL HEALTH AND SAFETY MANAGEMENT SYSTEM

Signatures & Approvals

Dr. Shafaq Ali Syed Signature:________________

Rizwan Umer Shaikh Signature:

List of Available SOP Related to Quality Management System Standard Clauses

 SOP for EHS policy

General Information of document

Document Name EHS MANUAL

Document Location EHS Department

Associated Documentation SOP Related to EHS Management System

Document Change History

Change Date Reason

1st Published 10.02.2021 New

Figure 1: Health and Safety Management System Process Model

Understanding the context of the Winthrox Laboratories Pvt. Ltd including

Monitor, measure, and evaluate EHS activities and

1. Development of an environmental health and safety policy;

The scope of this manual shall be applicable to the following areas:

EHS POLICY STATEMENT

2. WINTHROX LABORATORIES PVT. LTD integrated EHS management system into

4. At WINTHROX LABORATORIES PVT. LTD we encourage, communicate and ensure

2.1. Environmental Health and Safety Policy

3.0 Terms & Definitions.

EHSMS : Environmental Health and Safety Management System

1. Positive and negative factors or conditions.

4.2 Understanding the Needs and Expectations of Interested Parties

S.No Interested Parties Needs and expectations of the Interested Parties

4.3 Scope of the Environmental Health and Safety Management System

5.1 Leadership & Commitment: General

i) Assigning responsibility and accountability for effectiveness of the EHSMS.

Organizational roles, responsibilities and authorities.

The EHS Manager has responsibility and authority for:

1. Ensuring that the:

2. EHSMS is established, implemented and maintained in accordance with the requirements

5.4 Consultation and Participation of Workers

Appointment of Employee Health and Safety Coordinators

6.1 Addressing Risks and opportunities

The following have been considered in the development of the EHSMS:

 Enhance Desirable Effects

6.1.2.1 Hazard Identification

1. Routine and non-routine activities and situations, including consideration of

The organization has established implemented and maintained processes to:

6.1.2.3 Identification of EHS Opportunities and Other Opportunities

The organization has established implemented and maintained processes to identify:

1. Opportunities to enhance EHSMS performance taking into account planned changes to

6.1.3 Determination of Legal and other Requirements

The organization has:

The organization has planned to take actions to address its:

1. Significant environmental aspects, and address these risks and opportunities;

6.2 Environmental Health and Safety Objectives and planning to achieve

1. What will be done;

7.5 Documented Information

Documented information includes manual, procedures, records, information received or

Creating & updating documented information

Following are ensured while creating & updating documented information.

 Identification & description ( title , date, reference no)

Control of documented information