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ENVIRONMENTAL MANUAL

ENVIRONMENTAL MANUAL

Prepared By

QC Manager

Reviewed By

Production Manager

Approved By

CEO
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ENVIRONMENTAL MANUAL

INDEX
SECTION DESCRIPTION PAGE #
I Scope & Manual Control 4

II Company Profile 5

III Production plans 6

IV Environmental Policy 7

V Planning 8

Legal & Other Requirements 9

Objective & Targets 10

Environmental Management Program 11

VI Implementation & Operation 12

Training Awareness & Competence 13

Communication 14

Environmental Management System Documentation 15

Document Control 16

Operational Control 17

Emergency Preparedness & Response 18

VII Checking and Corrective Action 19

Non-Conformance & Corrective & Preventive Action 21

Records 22

Environmental Management System Audits 23

VIII Management Review 24

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ENVIRONMENTAL MANUAL

REV. # DATE INITIATED BY PAGE # NATURE OF AMENDMENT DONE BY

AMENDMENT SHEET
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ENVIRONMENTAL MANUAL
SECTION- I
SCOPE
This Manual is the governing document for the Safety and environmental Management System of Cure Laboratories .
This document provides the basic guidelines regarding management commitment regarding Environmental
Management system within the company.

The detailed requirements are referred, which can easily be traced for further information of the reader. EMS Manual is
applicable companywide and all functions can get guidance and information about company environmental systems
regarding:

 Environmental policy
 Objective and Targets
 Emergency Preparedness and response
 Internal and External Communication
 Environmental laws and Regulations
 Environmental Aspects Identification
 Internal Auditing
 Management Reviews
 Training and Awareness

MANUAL CONTROL & REVISION

This control procedure is applicable to only those copies, which are controlled. This document is written by
management Representative with consultation and inputs from Managing Director.

Management Representative is responsible for controlling the manuals. Management Representative updates the list of
manual receivers and ensures that they receive new or revised issue.

The manual shall carry the revision nil at the time of first issue. After any change there will be “Revision 1” and so on.
Change description shall be written on the amendment sheet attached with the manual. Revision to this manual shall be
made through Change Request Form. The Management Representative is authorized for any revision.

The controlled copies of this manual are those, which bear BLUE stamp mentioning;

CONTROL DOCUMENTS
“THE COLOR IS BLUE”

On every copy its copy # and Name of manual holder is indicated. The Management Representative will distribute
copies of manual to the concerned personnel.
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ENVIRONMENTAL MANUAL

SECTION- II
COMPANY PROFILE

Registered Office: Plot # Rawat Industrial Estate Islamabad Pakistan

Cure Laboratories the foremost name in Pharmaceuticals Manufacturing products and a symbol of excellence.
Cure Laboratories has the distinction of being the one of the best manufacturer in Pakistan by using state of the
art technology. Our Primary objective is the Customer Satisfaction and major commitment is the Quality.

COMPANY NAME : Cure Laboratories

ADDRESS : Plot # Rawat Industrial Estate Islamabad Pakistan

CHIEF EXECUTIVE :

QC MANAGER :

No. OF EMPLOYEES :

MAJOR PRODUCT Medicines

CATEGORIES: Capsules,Tablet,Syrups etc

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SECTION- III
PRODUCTION PLANS
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SECTION- IV
ENVIRONMENTAL POLICY

CURE LABORATORIES IS COMMITTED TO CONTINUE IMPROVEMENT TOWARDS ACHIEVING A

CLEAN, HEALTHY AND SAFE ENVIRONMENT. THE COMPANY CONDUCTS ITS ACTIVITIES FOR
MANUFACTURING OF MEDICINES IN A WAY THAT CONSERVES THE SAFE & HEALTHY
ENVIRONMENT IN THE FOLLOWING MANNER:

 PROVIDE TRAINING TO THE EMPLOYEES.

 DO TIMELY MAINTENANCE OF OUR MACHINES.

 MINIMIZE POLLUTION ACCORDING TO NATIONAL AND INTERNATIONAL RULES AND

REGULATIONS.

 CONTINOUSLY IMPROVE OUR ENVIRONMENTAL PERFORMANCE, PROMOTE SAFE

TRANSPORTATION OF MATERIALS AND PRODUCTS, REDUCE POLLUTION WITHIN OUR
OPERATIONS AND CONSERVE THE USE OF ENERGY.

MANAGING DIRECTOR
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ENVIRONMENTAL MANUAL

SECTION- V
PLANNING

ENVIRONMENTAL ASPECTS

Cure Laboratories shall identify all of its critical environmental aspects. For this purpose a joint effort
shall be made by all the related functions with lead roles of Management Representative and Production
Manager.

Cure Laboratories shall also consider the environmental aspects making significant environmental
impacts while setting its environmental objectives and targets.

Cure Laboratories shall also keep in view the National Environmental Quality Standards as well as
during its identification of environmental aspects.

The information pertaining to environmental aspects shall be kept updated on three monthly basis after
evaluation based on lab reports.

For details refer to:

Procedure for Environmental Aspect Identification & Monitoring EMS /QR/001

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LEGAL AND OTHER REQUIREMENTS

Cure Laboratories shall establish and maintain documented procedures to identify and access to legal
and other statutory requirements applicable to the activities and environmental aspects of the company’s
activities.

Management Representative shall be responsible to track and source the relevant environmental
legislation. Management Representative and QA department shall also be responsible to provide this
information to other related functions of the organization.

The relevant National Environmental Quality Standards (NEQS) shall be considered while setting its
objectives and targets.

For details please refer to;

Procedure for Tracking Environmental Laws and Regulations EMS/QR/005

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OBJECTIVES AND TARGETS

Cure Laboratories shall document and maintain documented objectives and targets for various
departments and levels of the company.

The consideration has been given while setting objectives and targets that these are in conjunction with
relevance to NEQS, the significant environmental aspects and maintenance operations. Also the attentions
have been devoted to technological, operational and financial constraints while setting up these objectives
and target.

The objectives and targets shall also be in harmony to Environmental Policy.

The environmental objectives and targets have been set as such that they aim to reduce pollution and at
the same time contribute towards the improvement of health and safety of employees and surrounding
communities.

Cure Laboratories objectives and targets have been set up such that the management staff and the
lower staff of the company share responsibilities to manage Environmental Management System and as a
consequence all of these share the benefits of the same.

For details please refer to;

Procedure for Setting Objectives and Targets EMS / QR / 007

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ENVIRONMENTAL MANAGEMENT PROGRAM

Cure Laboratories shall establish and document a program for attaining its environmental objectives and
targets. This program focus on various implications of environmental management system such that all of
these implications contributing in achieving environmental objectives and targets.

The responsibilities have been defined in Management Program for relevant departments of the
organization.

The resources required and the time frame by which objectives are to be attained has also been
documented in objectives and targets statement.

Cure Laboratories shall develop new environmental management program or modify the existing
program whenever a new project/process range is installed within the company and shall ensure that all
the relevant elements of environmental management system is applied to these new process range or
project.
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SECTION- VI
IMPLEMENTATION & OPERATION

STRUCTURE AND RESPONSIBILITY

Job descriptions shall be developed, documented and issued to all management staff of processing unit of Cure
Laboratories , covering their responsibilities and authorities regarding the effective operation of management system.
Companywide organization chart has also been developed to reflect the structure of Cure Laboratories ,
Environmental Organization.

RESOURCES

The executive management of Cure Laboratories ., shall remain committed to provide necessary resources required
for the effective implementation and operations of its environmental management system to the extent possible. The
resources will include human, technological, skills including the provisions of training and financial.

MANAGEMENT REPRESENTATIVE

The Executive Management of Cure Laboratories , shall appoint Head Quality Assurance as Management
Representative for ISO 14001 based on Environmental Management System. Head QA role, responsibility and
authorities have been defined and documented in his job description. However mainly he is responsible to;

Ensure that the environmental management system is established in the processing unit of Cure Laboratories and
that it is properly implemented and maintained in all the related functions according to the requirements of ISO 14001:
2004 International Standard.

Report on all matters of environmental management system to the executive management such that it becomes input for
the management review and at the same time become enough for the executive management to take appropriate
decisions for the improvement in the environmental management system.
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TRAINING AWARENESS AND COMPETENCE

Cure Laboratories has developed a documented procedure for training. The procedure aimed to identify the
training needs of all those personnel whose activities may impact a significant environmental impact and at the same
time keep a provision to provide such personnel to provide the required training on various environmental aspects and
impacts that are related to their work.

This procedure also aims to provide awareness to the employees regarding;

 The importance of adherence to the environmental policy and procedure and with all the environmental
requirements that can have any direct relation with their work in the organization.
 The significant environmental aspects and their corresponding impacts.
 The benefits of improved environmental practices.
 The roles and responsibilities of personnel in order to attain environmental policy and procedures, the
requirements of environmental management system standards and the procedures for emergency preparedness
and response.
 The undesirable results that all the interested parties may face in case of deviation from environmental
procedures and practices.

The personnel shall be made competent and/or qualified on the basis of training, education or experience.

For details please refer to:

Procedure for Training

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COMMUNICATION

Cure Laboratories shall establish procedures for communication regarding environmental aspects or related
impacts to various levels of organization or with external interested parties.

Various departments and personnel of the company communicate clearly and in most practicable way. These
communications shall cover health, safety aspects, corrective and preventive actions, results of deteriorated or
improved environmental practices and awareness on environmental aspects or any critical part of the Environmental
Management System.

The Communication with external interested parties like local authorities, legislation bodies, consultants, certification
agencies, and members of society are properly understood and acted upon by the management of Cure Laboratories
.

For details please refer to:

Procedure for Internal Communication

Procedure for External Communication
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ENVIRONMENTAL MANAGEMENT SYSTEM DOCUMENTATION

Cure Laboratories has established and documented its Environmental Management System. Following is the
structure of documentation:-

LEVEL 1

Environmental Manual describes the core element of the management system and at the same time it provides
references and direction for various procedures of Environmental Management System.

LEVEL 2

The procedures provide details on various areas of environmental management system are operational and that
it is effective.

LEVEL 3

These are Work Instructions and Standard Manual, which Provides details on various instructions during
working and composition of products.

LEVEL 4

These are records, which becomes evidence that the environmental management system is operational and that
it is effective.
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DOCUMENT CONTROL

The documented procedures shall be developed and maintained by Management representative and issued to all
relevant departments for the effective control of all environmental management system documents such that:

Documents can be located and are easily retrievable.

They are reviewed on annual basis, or revised whenever they are required to maintain an effective management system
and approved by the authorized personnel of the company.

The latest environmental management system documents are issued to all areas so that all aspects of environmental
management system are well covered and that the relevant information is available within all departments for their
effective functioning with respect.

The system provides provision for prompt removal of obsolete documents from all points of issue and use and that they
are properly identified as obsolete documents.

Documents, which are maintained for legal or reference purposes are properly identified.

The procedures shall be developing to ensure that document is legible, dated, identified, and suitably maintained
(filed). The relation provides shall be defined, responsibilities shall also be tabulated for the creation and modification
in environmental management system documents.

For details please refer to:

Procedure for of document & data control

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OPERATIONAL CONTROL
According to the scope of environmental management system (Production unit and relevant activities) Cure
Laboratories has identified that noise and effluent is the major environmental aspects of its activities.

The wastage produced during the operations is properly stored and sold out keeping in view that it is not further used
in any activity, harmful for the environment.

Also keeping in consideration the environmental policy, objectives and targets, Cure Laboratories has provided
the earplugs to all the workers working in the Noise producing area.

Simultaneous to the ear plugs provision the proper maintenance of the machinery is also being carried out at planned
intervals.

Regarding effluents treatment plan has been constructed and all of the industrial effluents running out of the factory is
proper treated.

The Production Manager along with the Management Representative provide training to the workers for the use of ear
plugs, more over safety instructions in the form of posters are also pasted in the working areas.

For more detail please refer to:

Work Instructions for Production

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EMERGENCY PREPAREDNESS AND RESPONSE

Cure Laboratories has established and documented procedures to identify the potential safety, health and
environmental hazards and to respond to accident and emergencies and to effectively minimize the effects associated
with such accidents or emergencies.

This procedure shall be reviewed and revised for their adequacy in case the accidents occur and it is found that the
procedure does not provide sufficient information to the employees or interested parties to effectively respond to
accidents or emergencies.

The firebreak out has been identified as major emergency breakdown at Cure Laboratories and fire fighting
training has been imparted to the relevant employees. Sufficient firefighting equipment has been provided at different
places, where it required. The procedure had been laid down to respond effectively in such situations.

For more detail please refer to:

Procedure for Emergency Preparedness and Response

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SECTION- VII
CHECKING AND CORRECTIVE ACTION

MONITORING AND MEASUREMENT

Cure Laboratories has established and maintained procedure to monitor and measure the key characteristics of
such operations and activities that each has a significant impact on environment. To carry out such monitoring and
measurement the system has been developed in conjunction with Environmental Management Program to track
performance, effectiveness of relevant operation control and adherence to environmental objectives and targets.

CALIBRATION

The monitoring equipment has been calibrated from external agencies and appropriate record has been maintained.

For more detail please refer to:

Procedure for Inspection, Measuring & Test Equipment

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COMPLIANCE TO REGULATIONS

Management Representative and Production Manager of Cure Laboratories are responsible for tracking any
change in the applicable laws. To keep this issue updated Management Representative calls or if required visits the
concerned agencies, so as to get the latest environmental legislation and regulations. The management representative
also maintains a separate file for applicable environmental laws and regulations.

For more detail please refer to:

Procedure for tracking environmental laws and regulations

Procedure for environmental Aspects identification

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NON CONFORMANCE & CORRECTIVE AND PREVENTIVE ACTION

Documented procedures have been developed and implemented to ensure that wherever any problem is identified the
appropriate corrective and preventive action is taken.

Investigation to establish cause of a problem. Initiation of corrective action and ensuring non-reoccurrence of causes
leading to environmental problem.

Analysis of corrective methods, Records and surrounding complaints, to eliminate causes of problem.

Implementation of documented changes in the relevant procedure for avoiding future reoccurrence of similar problems.

The corrective and preventive actions shall be provided as input for the Executive Management Reviews.

For more detail refer to:

Procedure for Corrective and Preventive Action

Procedure for Control of non-conforming products

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ENVIRONMENTAL MANUAL

RECORDS

Environmental record will be decentralized and shall be the responsibility of respected departments/ sections.
Procedures are maintained for the identification, maintenance and disposition of environmental records related to
wastage, training, audits and revisions and checking of the status of environmental improvement.

Master list of environmental records has been established and documented and provided to all the departments of the
company to ensure the continuous compliance to the procedure for environmental records. All the records are legible,
identifiable, traceable and retrievable.

Retention Time has also been mentioned. All the records are appropriate to the Environmental Management System
and to the organization and to fulfill the international standard with their conformance to Environmental Management
System.

For more details please refer to:

Procedure for document & data control

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ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT

Cure Laboratories has established and maintained a documented procedure for environmental auditing. Also an
auditing program has been established in the light of their procedures.

The procedures for Environmental Management System Auditing are aimed to:

 Meet all the requirements of ISO-14001: 2004 International Standard and to the procedure, programs, policy,
objectives and targets developed and set forth regarding the development of Environmental Management
System.
 Has been effectively implemented and that it is followed perpetually.
 Ensure that audit results are effectively reported to the management.

The audit program shall be developed as such that they cover the audit schedules, and are based on the degree of
environmental importance of the activities and the results of previous audit.

The procedure for Environmental Management System Auditing has been developed to cover for audit scope,
frequency of audit methodology, assigning responsibilities to manage and conduct audits and reporting the results of
audit by documented means.

The results of Environmental Audit shall be the input for Management Review Meeting.

For details please refer to:

Procedure for Internal Quality & Environmental Audits

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SECTION- VIII
MANAGEMENT REVIEW

EXECUTIVE MANAGEMENT

Regular review meeting, chaired by the Chairman, are held to monitor the effectiveness of the Environmental System.
The regular features of management review are improvement towards attaining objectives, results of internal audits and
requirement of resources. However any other matter related to Environmental Management System may also be
discussed. Management Representative shall maintain records of all such reviews. A documented procedure has also
been established in this regard.

For details please refer to:

Procedure for Management Review