ENVIRONMENTAL MANAGEMENT PLAN

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CHAPTER 1: INTRODUCTION
The pharmaceutical industry develops, produces, and markets pharmaceutical drugs for use as
medications. Pharmaceutical companies may deal in generic or brand medications and medical
devices. They are subject to a variety of laws and regulations that govern the patenting, testing,
safety, efficacy and marketing of drugs. Pharmaceuticals Sector in Pakistan presently forms a 3.2
billion USD industry, growing at a swift 15% annually. The Pharmaceutical sector has seen massive
changes over the past decade, providing essential health care products to citizens and introducing
them to revolutionary pharmaceutical preparations. Today, there are more than 700 pharmaceutical
manufacturing units in Pakistan exporting products worth over $200 million to more than 60
countries.

This report discusses the Environmental Management Plan of Brookes Pharma Pvt Ltd. (hereinafter
referred to as Brookes Pharma) located at Plot # 58 & 59, Sector ، 15 Main Korangi Industrial Local
Rd, Sector 15 Karachi, 74900.

According to section 20 of the Sindh Environmental Protection Act 2014, (SEP-Act 2014) Sindh EPA
requires an environmental audit or environmental review report or environmental management
plan to be submitted by project in-charge, containing a comprehensive appraisal of the
environmental aspects of the project.

The objective of this EMP is to discuss the existing environmental conditions in vicinity of the
pharmaceutical industry under the scope, to state impacts of the processes on the environment and
to propose necessary measures to mitigate possible negative impacts arising from these aspects.
More specifically, the objectives of this EMP are as follow:

 To establish a baseline of existing environmental conditions at the project site by collecting

primary and secondary data on physical environment of the production area.

 To help the Brookes Pharma management in incorporating necessary measures, still

needed, for legal compliance and socially acceptable environmental performance of their
plant.

 To identify significant environmental impacts during operational stage and propose

mitigation measures for the negative impacts.

The scope of this report is derived from the requirements and guidelines as stipulated in the Sindh
Environmental Protection Act 2014 and its supporting statutes. As per their scope of work, it has
included the following sections in the report:

Description of the Project: Facility process is provided in this report to give information about the
types of industrial processes that are under the scope of the report, using appropriate visual aids
(maps, photographs, satellite imageries etc.) where necessary.

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Legislative and Regulatory Considerations: This report describes the relevant legislation,
regulations and standards, and environmental policies which are relevant and applicable to the
project. It also identifies the appropriate authority jurisdiction that is specifically applied to the
project.

Potential Impacts of the Project: Impacts related to the project were identified and distinction for
significant impacts was made between positive and negative, direct and indirect, short and long
term during operational phase. Impacts that are cumulative, unavoidable or irreversible have also
been identified. Special attention was paid to:
 Impacts of the project on water quality
 Impacts of the project on air quality
 Impacts on workers' health and safety

Mitigation measures of Adverse Impacts: Possible measures to prevent or reduce significant

negative impacts to acceptable levels have been identified. Recommendations to adopt feasible
mitigation measures are also included in the report.

Development of an Environmental Monitoring and Management Plan : The critical issues

requiring monitoring to ensure compliance to mitigation measures are identified and an
environmental management and monitoring plan for operations has been presented.

The consultant was mobilized after fulfillment of necessary contractual requirement by Brookes
Pharmaceutical Laboratories (Private) Limited. The methodology adopted by the consultant for this
assignment had been agreed upon with the proponent at the proposal stage.

Orientation Session:
Meetings and discussions were held with the relevant key officials of Brookes Pharmaceutical their
facility. This activity was aimed at achieving a common ground of understanding on various issues of
the study. The consultants followed best practices and standards as employed by international
engineering community to complete this assignment within the pre-agreed scope of work. The
following several steps of methodology were followed:

Data Collection:
Site Visits:
The consulting team conducted visits of the Brookes Pharmaceutical facility. Subsequent visits to the
site were made in order to collect necessary data pertaining to their respective areas of
responsibility within this assignment. The Consultant physically and visually observed the
manufacturing site, took photographs and noted existing environmental conditions. These visits also
helped in verifying various pieces of information provided by Brookes Pharmaceutical.

Collection of Primary Data:

In this step, a detailed checklist was used as a guide, to collect all the concerned environmental data
of the industry. Some primary data was available with the Brookes Pharmaceutical management,
while some data was collected by the consultants.

Data Analysis:

Impact Identification & Screening:

On the basis of data collection in above steps, actions or activities having potential to cause damage
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to environment were listed. The potential negative impacts were identified for Brookes
Pharmaceutical activities.

Impact Evaluation:
Description of the project's impacts on various environmental receptors and elements was made
and a subjective evaluation of their significance was carried out.

Review of Legal and Administrative Framework:

A review on all relevant environmental policies and national, international and provincial laws and
guidelines were compiled.

Development of Recommendations:
Mitigation measures for major impacts were identified. Approach for suggesting mitigation
measures were as follows, in the descending order of preference:

 Minimizing impacts by limiting the degree or magnitude of the action and its
implementation;
 Rectify the impact by repairing, rehabilitating, or restoring the affected environment;
 Reduce or eliminate the impact over time by preservation and maintenance operations
during the life-of the action
 Compensate for the impact by replacing or providing substitute resources or
environments.

A conceptual Environmental Management Plan (EMP) for smooth and effective implementation of
all recommended mitigation measures has been developed and included in the report.

Reporting:
The final report of Environmental Management Plan of Brookes Pharmaceutical has been prepared
under the guidelines issued by the Sindh Environmental Protection Act 2014. This final report will be
submitted to the management of Brookes Pharmaceutical for onwards submission to the Sindh
Environmental Protection Agency. The Environmental Management plan is concise and limited to
significant environmental issues. The main text has been focused on findings conclusions and
recommended actions. It is supported by summaries of the data collected during visit and provided
by Brookes Pharmaceutical.

This document has been prepared drawing inferences from site visits and primary data. The study
has been conducted by the consultants in a manner consistent with the level of care and skill
ordinarily exercised by members of environmental engineering and consulting profession. The
consultants have tried to cover all important aspects and relevant impacts. However, this report may
not exhaustively cover an investigation of all possible environmental conditions or circumstances
that may exist.

The conclusions in this study are based on the primary data and a subjective evaluation of the
possible environmental aspects that may influence the existing environmental status of the site
during operations of the project. In evaluating this project, the consulting team has relied on
information provided by the company management. The consultants assume that the information
provided is factual and accurate; and accept no responsibility for any deficiency, misstatement, or
inaccuracies contained in this report as a result of omission or misrepresentation by any person
interviewed or contacted.

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It should be recognized that the passage of time affects the information given in this report.
Environmental conditions of a site can change. Opinions relating to the specific conditions are based
upon information that existed at the time the conclusions were formulated.

The mitigation measures and other recommendations put forth in this report are of the level of
conceptual design and implementation framework. The detailed designing and implementation of
recommended measures are not part of the current assignment scope.

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CHAPTER 2: FACILITY DESCRIPTION

2.1 COMPANY PROFILE:
Brookes pharmaceutical (private) limited are a private limited company founded in 1986, by its
present chairman and chief executive, Mr. Waseem I. Khan. Brookes Pharmaceutical is the 1st
Pakistan based multinational pharmaceutical manufacturing concern with its own manufacturing
facility based in Karachi.

The Brookes Pharmaceutical Company is an ISO 9001 :2015, 14001:2015, 45001: 2018 certified.
Brookes Pharmaceutical presently ranked at No. 02 in Pakistan as per unit wise sales. Brookes
Pharmaceutical started manufacturing and marketing operations %with anti-inflammatory and
potassium supplements besides iron preparations. Today Brookes Pharmaceutical product range
above 175 products.

Brookes Pharmaceutical is an equal opportunity employer and employs a staff of around 3000 with
around 50% being females. Brookes Pharmaceutical has one of the largest manufacturing facilities in
Pakistan with total covered area of over 155,875 square feet. Brookes Pharmaceutical has fully
equipped central quality assurance/control laboratories to monitor quality at all facilities. The
management of Brookes Pharmaceutical has a developed an internal quality audit plan to check the
effectiveness of the command-and-control system and a cross facility.

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Figure 2.1:
Pictorial
Image of
the facility

Brookes

Pharmaceutical
located at Plot #
58 & 59, Sector،
15 Main Korangi
Industrial Local
Rd, Sector 15
Karachi, 74900.
Google image
showing location
of the facility is
presented in
Figure 2.1

Figure 2.2: Location of the facility

2.2 MANAGEMENT STRUCTURE:

Chief Executive is overall in-charge of the facility which is supported by Managers of different
departments. Further each manager is followed by Assistants, supervisors, officers and other staff.

2.3 CERTIFICATIONS:
Brookes Pharmaceutical Company is an ISO 9001:2015, 14001:2015, 45001:2018 Certified.

2.4 PROCESS DESCRIPTION:

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Brookes Pharmaceutical used raw material consists of many chemicals. During the process raw
materials are moved from main store to dispensing area and then shifted to containers with
required quantity. Subsequently the requisite raw material undergoes process like mixing, blending
drying, and coating, tableting, filling and packing.

2.4.1 De-Dusting and Sampling

At first stage all newly arrived raw material in form of drums, packs, bottles, pouches (small & large)
and cartons are de-dusted through industrial vacuum cleaner in de-dusting area. Subsequently a
portion of raw material which represents the whole characteristics of the material is collected in
sampling area.

2.4.2 Quarantine Section

After de-dusting raw material is then shifted to Quarantine section and stored until signal from
quality control (Q.C) is received. Material not complying with the quality requirement is considered
as rejected material and is sent back to the supplier.

2.4.3 Raw Material and Cold Store

After clearance from Q.C the raw material from quarantine section is moved to approved area where
it is kept on separate racks with proper labelling and grouping.

2.4.4 Dispensing Area

Dispensing area consists of two portions first one is dispensing room where the material is weighed
as per requisite from production section and 2nd is dispensed QC area where the material are
sample for testing.

2.4.5 Laboratory

The laboratory mainly has five divisions namely Physical, Chemical, listing Microbiological, Poelcaguy
material listing, Packaging material and compliance cell. The function of laboratory is to assure the
quality of product and also check the raw material quality for pharmaceutical utilization.

Therefore it plays vital roll with promise to maintain the excellent quality. The laboratory follows
standard method of analysis for physical, chemical, microbiological parameters as per requirement
of customer.

2.4.6 Warehouse

The finished product of the facility after passing QA/QC test is stored in warehouse for further
dispatch to the clients.

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2.4.7 Finished Products

2.5 DETAILS OF UTILITIES AND OTHERS:

2.5.1 Electricity / Power Requirements

The power requirement for the facility is mainly obtained from the K-Electric. For power backup
facility has Generators, which are used in case of power failure and load shading.

2.5.2 Water

Water requirements of the facility are being fulfilled by Karachi water & Sewerage Board.

2.5.3 Gas

Gas is supplied by Sui Southern Gas Company (SSGC) at Brookes Pharmaceutical.

2.5.4 Solid Waste

Solid waste generated from the facility mainly consists of plastic strips, seals, laboratory waste (i.e.
papers, wasted chemical and analysis residues), cartons, bags, drums, poly bags, packing materials,
raw material residues & damaged blister, glass, aluminum caps, broken ampules, broken vials,
aluminum cover pieces & process material, used oil, chemical cans, office waste, and domestic
waste.
The solid waste is collected in waste bins and disposed-off through solid waste disposal contractor.

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2.5.5 Waste Water

Main source of waste water at facility comes from process, washing, utilities and domestic ends.

Chapter 3: LEGAL FRAMEWORK

The enactment of comprehensive legislation on the environment, covering multiple areas of
concern, is an ongoing phenomenon in Pakistan. The basic policy and legislative framework for the
protection of the environment and overall biodiversity in the country is now in place. The detailed
rules, regulations and guidelines required for the implementation of the policies and enforcement of
legislation are also in place.

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This chapter discusses the current legal framework in the background of the environment and
sustainable development and the institutions that exist in the country that may influence the
environmental management of facility.

3.1 NATIONAL REGULATIONS

3.1.1 National Conservation Strategy

The environmental policy framework, which will govern the project, is the National Conservation
Strategy (NCS) of Pakistan. The NCS was developed in more than nine-year period (1983-1992) after
an extensive consultation process with thousands of experts, interested individuals, communities,
NGOs and government agencies. The federal cabinet approved the document in March 1992, as the
principal policy document for environmental management in the country. The three principal
objectives of the NCS are:

 Conservation of natural resources

 Sustainable development
 Improved efficiency in the use and management of resources

Three operating principles are identified to achieve these objectives. These are:

 Greater public participation in development and environmental management;

 A merging of environmental and economic decision making;
 Lasting improvements in the quality of life.

The NCS sets out the basic guidelines for an integrated effort aimed at protecting the environment
and the natural resources of the country. This broad framework provides a comprehensive point of
reference for all agencies, departments, private sector companies, financial institutions, and donor
agencies for undertaking systematic efforts to bring about an effective change for sustainable
development.

3.1.2 National Environmental Policy, 2005

The National Environment Policy (NEP) aims to protect, conserve and restore Pakistan's environment
in order to improve the quality of life of the citizens through sustainable development. The
objectives of the Policy are to:

 Secure a clean and healthy environment.

 Attain sustainable economic and social development with due regard to protecting the
resource base and the environment of the country.

3.1.3 The National Climate Change Policy, 2012

The National Climate Change Policy comprehensively addresses all possible challenges of Climate
Change adaptation and mitigation in foreseeable future; and ensures to provide foundational
framework for ensuing Climate Change Action Plans, Programs and Projects.

In view of Pakistan's high vulnerability to the adverse impacts of climate change, in particular
extreme events, adaptation effort is the focus of this policy document. The vulnerabilities of various
sectors to climate change have been highlighted and appropriate adaptation measures spelled out.

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These cover policy measures to address issues in various sectors such as water, agriculture, forestry,
coastal areas, biodiversity and other vulnerable ecosystems. Notwithstanding the fact that Pakistan's
contribution to global greenhouse gas (GHG) emissions is very small, its role as a responsible
member of the global community in combating climate change has been highlighted by giving due
importance to mitigation efforts in sectors such as energy, forestry, agriculture and livestock

3.1.4 Sindh Environmental Protection Act, 2014

After 1 8th Amendment, Sindh Environmental Protection Act 2014 was approved by Sindh legislative
assembly. The Sindh Environmental Protection Act 2014 is the basic legislative tool empowering the
Sindh government to frame regulations for the protection of environment. The Act is applicable to a
broad range of issues and extends to air, water, soil, marine and noise pollution, as well as the
handling of hazardous waste. Before this act, Pakistan Environmental Protection Act 1997 (PEPA- 97)
was applicable.

The requirement for environmental assessment is laid out in Section 17 of SEP-Act-2014. Under this
section, no project involving construction activities or any change in the physical environment can be
undertaken unless an Initial Environmental Examination (IEE) or an Environmental Impact
Assessment (EIA) is conducted, and approval is received from the Federal or relevant Provincial EPA.

According to section 20 of the Sindh Environmental Protection Act 2014, (SEP-Act 2014), project in-
charge is required to submit an environmental audit or environmental review report or
environmental management plan to Sindh EPA, Which contains a comprehensive appraisal of the
environmental aspects of the project. This Environmental Management Plan has been prepared for
the said facility, under the general guidance of EPA-Sindh.

Sections 11 and 14 of SEP-Act 2014 are the most relevant clauses of this Act as far as the operations
of the facility are concerned:

 Section 11prohibits discharge or emission of any effluent or waste or air pollutant or noise in
excess of the Sindh Environmental Quality Standards (SEQS), or the established ambient
standards for air, water or land.
 Section 14 prohibits the handling of hazardous substances except under license or in
accordance with provision of any local law or international agreement.

A copy of SEP-Act 2014 is attached as Annexure of this report.

3.1.5 SEPA (Review of IEE/EIA) Regulations, 2014

The Sindh Environmental Protection Agency (Review of IEE/EIA) Regulations, 2014 divides projects in
Schedule I, Ill depending upon the severity of environmental impacts of the project as follows:

Schedule-I: A project falls in Schedule-I if it is likely to have adverse environmental impacts, but of
lesser degree and significant and all the mitigation measures to handle the impact is manageable.
Such types of projects need IEE report including EMP.

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Schedule-Il: Projects are categorized in Schedule-Il if they generate significant adverse

environmental impacts that require a comprehensive management plan, or if the project is located
within or passes through: a) Areas declared by the Government of Pakistan as environmentally
sensitive (National Parks/Sanctuaries/Game Reserves), b) Areas of the international significance (e.g.
protected wetlands as designated by the RAMSAR Convention), or c) Areas designated-by the United
Nations Educational, Scientific, and Cultural Organization (UNESCO) as cultural heritage sites.
Projects falling in schedule II need an EIA.

Schedule-III: Project having localized impacts fall in schedule Ill and require an Environmental
Assessment checklist.

These regulations are attached in Annexure.

3.1.6 Sindh Environmental Quality Standards (SMART) Rules, 2014.

Sindh Environmental Quality Standards (Self-Monitoring and Reporting by industry) Rules, 2014
classify the industrial units into category A, B or C for liquid effluent and category A or B for gaseous
emissions on the basis of pollution level of an industry. These rules determine the priority
parameters and frequency for monitoring of effluent and gaseous emissions. According to these
rules facility has to monitor its liquid effluents on defined frequency from Sindh EPA approved
Laboratory and a monitoring report of the same will be submitted to Sindh EPA. A copy of SEQS
(SMART) Rules. 2014 is attached as SEQS Rules, 2014 are attached as Annexure.

3.1.7 Sindh Environmental Quality Standards, 2015

SEQS, promulgated under SEP-Act 2014, specify the standards for the industrial and municipal
effluents, gaseous emissions, vehicular emissions and noise levels, a copy of these is attached as
Annexure of this report. These prescribe the allowable discharge limits of pollutants to air or water.
Consequently, industrial and other locations generating toxic/aggressive effluents have to provide
special in-house treatment before dumping into the public sewer or any other receiving body, as the
case maybe.

The legislation describes separate pollution limits for wastewater, based on the receiving body; i.e.
there are different limits set for wastewater being discharged into inland waters, into sewage
treatment plant, and into the sea.

3.1.8 Hazardous Substance Rule, 2014

Section 13 of the SEP-Act 2014 requires that "no person shall generate, collect, consign, transport,
treat, dispose of, store, handle or import any hazardous substance except under a license issued by
the SEPA and in such manner as may be prescribed; or in accordance with the provisions of any
other law for the time being in force, or of any international treaty, convention, protocol, code,
standard, agreement or other instrument to which Pakistan is a party." SEPA has Hazardous
Substance Rules to implement the licensing requirement. A copy of Hazardous substance rules 2014
is attached as Annexure

3.1.9 Pakistan Penal Code, 1860

The Pakistan Penal Code deals with the offences where public or private properties and/or human
lives are affected due to intentional or accidental misconduct of an individual or body of people. In

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the context of environment, the most relevant clauses of this law have been summarized in the
following:

Section 277: Fouling water of public spring or reservoir: Whoever voluntarily corrupts or fouls the
water of any public spring or reservoir, so as to render it less fit for the purpose for which it is
ordinarily used, shall be punished with imprisonment of either description for a term which may
extend to three months, or with fine which may extend to [one thousand five hundred rupees], or
with both.

Section 278: Making atmosphere noxious to health: Whoever voluntarily vitiates the atmosphere in
any place so as to make it noxious to the health of persons in general dwelling or carrying on
business in the neighborhood or passing along a public way shall be punished with fine which may
extend to (one thousand five hundred rupees).

Section 285: Negligent Conduct with respect to fire or combustible matter: Whoever does, with fire
or any combustible matter, any act so harshly or negligently so as to endanger human life, or to be
likely to cause hurt or injury to any other person, or knowingly or negligently omits to take such
order with any fire, or any combustible matter in his possession as is sufficient to guard against any
probable danger to human life from such fire or combustible matter, shall be punished with
imprisonment of either description for a term which may extend to six months, or with fine which
may extend to [three thousand rupees] or both.

3.1.10 The Factories Act, 1934

This is not strictly an environment related statute, but does incorporate many clauses pertaining to
general environmental conditions and occupational health and safety issues.

3.2 INTERNATIONAL GUIDELINES:

3.2.1 International Convention Adopted by Pakistan.

Pakistan is a party to some 24 international treaties, conventions and Multi-lateral Environmental

Agreements (MEAs) on the themes of environment, pollution and ecology. However, none of these
is directly relevant to the proposed project.

3.2.2 Institutional Setup for Environmental Management.

The structural setup of agencies/departments in the environmental sector is such that the Federal
Ministry' of Climate Change governs and regulates environment-related work at the central and
international level. The PEPA works directly under the control of ministry at the federal level. The
provincial environmental protection agencies regulate environmental related work at the provincial
level under its own ministry of environment. After 18th amendments, these ministries can now hold
more power to enact laws pertaining to their provinces. The institutional framework is such that the
Ministry of Climate change deals with environment and wildlife issues at the Federal level.

3.2.3 Pakistan Environmental Protection Council (PEPC) and the Pakistan

Environmental Protection Agency (PAK-EPA).

Before 18thamendmentthese two organizations, PEPC and Pak-EPA are primarily responsible for
administering the provisions of the PEPA 1997. The PEPC oversees the functioning of the Pak-EPA.
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Its members include the representatives of the government, industry, nongovernmental

organizations and the private sector. The Pak-EPA was required to ensure compliance with the
NEQS, establish monitoring and evaluation systems, and both identiW the need to, as well as initiate
legislation whenever necessary. The provincial EPAs were the provincial arms of the federal EPA,
which were authorized to delegate powers to its provincial counterparts.

After the devolution of several of the Centre's powers to the provinces through the passage of the
18th constitutional amendment in 2010, the provincial chapters of EPA have been granted status of
provincial agency.

3.2.4 Sindh Environmental Protection Agency (SEPA).

For all practical purposes, the Sindh chapter of the Pakistan Environmental Protection Agency,
headed by a director general, has been granted the status of provincial agency. The agency would
carry out wide-ranging functions including advising the council about legislation, development
schemes and expenditure. Its main job would be to ensure that all provisions of the Sindh
environment bill were implemented, otherwise take the necessary action about it.

The functions of SEPA also include, ensuring the compliance with the Sindh Environmental Quality
Standards (SEQS), monitoring and surveillance, issuing of licenses, identifying the need for legislation
and development schemes, assisting government agencies in relief work in case of an environmental
disaster and advising the government on legislation and expenditure. The SEPA DG may authorize
any officer to inspect any land building premises in which there is reasonable ground for an offense.

Chapter 4: ENVIRONMENTAL MANAGEMENT PLAN

4.1 OVERVIEW OF EMP:

This chapter identifies potential impacts of the project due to company activities and operations and
outlines the implementation mechanism for Environmental Management Plan (EMP) and defines the
institutional arrangements required for the implementation of the plan. The EMP provides the
implementation mechanism for the identified mitigation measures.

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The significance of impacts involves a value judgment technique. Impact significance depends not
only on the magnitude of the impact but also on the sensitivity of the receptor. The more sensitive
receptor with greater magnitude of change, the greater will be the significance of the impact of that
change. For the purpose of this report, the term "Environmental Impact" or simply "Impact "
includes the negative, adverse or harmful as well as positive, desirable or beneficial impacts of the
project.

For identification of potential impacts of company significant environmental aspects, screening of

activities causing impacts has been carried out. In order to evaluate the impacts, first the major
project activities with their associated environmental issues are identified and then their impacts are
evaluated.

The description of company manufacturing operations has been explained in Chapter 2. The
environmental issues that can arise due to the operation of the plant and the associated health,
safety impacts and mitigations are discussed in the following sections. The appropriate
environmental management measures to handle these issues are also discussed later in this report.

The mitigations/ recommendations given in this section includes several suggestion, that are already
been implemented by company. This shows that company is already conversant with the
environmental issues and is trying to address the environmental concerns. The purpose of
presenting these is to make the report complete in all respect as well as to make sure that its proper
monitoring is done for giving desired results.

4.1.1 Scope of EMP

The scope of EMP encompasses the identification of environmental hazards, evaluation of the risk
management system adopted by the company, environmental compliance status of the company,
evaluation of the occupational health & safety standard adopted. Inspection of pertinent record,
analysis of the lab reports conducted through environmental certified laboratory for gaseous
emissions, waste water generated and drinking water at facility. Solid waste management was also
evaluated.

4.1.2 Objectives of Environmental Management Plan

The specific objectives of the EMP are to:

 Define the applicable legal requirements.

 Establish a framework for environmental management of the proponent's operations within
its facility.
 Identify the key environmental issues that are relevant to the operations of the facility.
 Prevent the pollution of soil, groundwater and surface water resources during operations.
 Minimize odors, Green House Gases (GHG) emissions.
 Ensure waste minimization and should have waste management practices.
 Define roles and responsibilities and;
 Define monitoring and reporting procedures.
 Identify training requirements at various levels and provide a plan for implementation.

4.1.3 Structure of EMP

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EMP is made in such a manner that it helps to improve environmental outcomes, therefore it is
comprises of the following main areas:
 Relevant statutory obligations
 Management Structure and general responsibilities for staff involved in the Operations
 Environmental management and monitoring plan
 Trainings, Communication and Documentation
 Change management plan.

4.2 MANAGEMENT APPROACH:

The environmental management will require specific approach in order to handle the issues
effectively. Management will assign the roles and responsibilities to be performed during its
operations.

The facility will look after the compliance on EMP during operations. It will ensure that all activities
executed must comply to all the environmental regulations as well as cooperation will be bridged
with concerned regulatory authorities such as Sindh Environmental Protection Agency (SEPA).

Some of the approaches to be followed during the environmental management practices are given
below:
 Complying with the relevant legislation and regulations.
 Regularly reviewing of the impacts on the environment.
 Developing appropriate indicators in order to monitor core impacts.
 Setting appropriate annual objectives, targets and publicly reporting on progress.
 Monitoring supplier's environmental management arrangements.
 Communicating openly with internal and external stakeholder on environmental issues, if
relevant.

4.2.1 General Organizational Structure for Environmental Management Plan

Keeping in view the magnitude of operations of Brookes Pharmaceutical, following organizational

structure is recommended for the implementation and maintenance of Environmental Management
Plan:

4.2.2 Roles & Responsibilities

Environmental management should be the internal part of the corporate policy of the facility.
Therefore, committing to reduce the environmental impacts will affect the management approach
and ensures that good environmental performance in this area accelerate the running of well
managed and efficient business

Main responsibility for environmental performance will be governed by the Engineering Manager of
Facility, while daily management will be supervised under the direction of EHS officer or person
designated by Engineering Manager. A brief structure of roles and responsibilities is given below:

1) Managing Director:

Environmental management plan will be regulated by the Managing Director, who will be the
decision making authority. Some of the important roles to be provided by Manager Admin are given
below:
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 To consider and react to issues rose by the Manager Admin and provide solutions.
 To cooperate and consult with relevant environmental agency in order to perform in better
way.
 To evaluate the progress of development and implementation of the management plan.
 To approve any change in decision making system in consultation with Manager Admin, if
appropriate.

2) Manager Systems & Compliance:

The Manager System and compliance is the head of the Environmental Management Plan (EMP).
Environmental Management Plan will be regulated by the Manager, who will be the decision making
authority. All the decisions will be made under his guidance in the light of Environmental
Management Plan (EMP). Some of the roles of Manager System and compliance will be:
 Decide which of the major incident requires response from the management.
 To review the environmental policy and procedures and update those as and when required.
 Decide whether the incidence should be categorized as major by consultation with managers
in the managerial meetings
 To consider and react to issues rose by the EHS department and provide solutions.
 To evaluate the progress of development and implementation of the management plan.
 To approve any change in decision making system, if appropriate.
 Ensure that the Production In charge/EHS Engineer should be available for out-of-hours
notifications of major incidents.

3) Manager Admin:

Manager Admin is responsible to report to Head of Corporate Security and Administration. Under his
guidance the Civil Defense Officer and his team will be performing their activities. Some of the
responsibilities of the Manager Admin are as follows:
 Maintains staff by recruiting, selecting and orienting employees;
 Maintains a safe and secure work environment;
 Develops personal growth opportunities.
 Provides supplies by identifying needs; establishing policies, procedures, and work
schedules.
 Provides communication systems by identifying needs; evaluating options; approving
invoices.
 Purchases printed materials and forms by obtaining requirements; negotiating price, quality,
and delivery; approving invoices.
 Maintains continuity among corporate, division, and local work teams by documenting and
communicating actions, irregularities, and continuing needs.
 Contributes to team effort by accomplishing related results as needed.

4) Manager EHS:

The Manager EHS is the head of the Environmental Management _ Plan (EMP). Environmental
Management Plan will be regulated by the Manager, who will be the decision making authority. All
the decisions will be made under his guidance in the light of Environmental Management Plan
(EMP). Some of the roles of Manager EHS will be:
 Decide which of the major incident requires response from the management.
 To review the environmental policy and procedures and update those as and when required.

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 Decide whether the incidence should be categorized as major by consultation with managers
in the managerial meetings
 To consider and react to issues rose by the EHS department and provide solutions.
 To evaluate the progress of development and implementation of the management plan.
 To approve any change in decision making system, if appropriate.
 Ensure that the Production In charge/EHS Engineer should be available for out-of-hours
notifications of major incidents.
 To provide in-house EHS trainings to the staff as and when required
 Set up first Aid Setup

5) First Aid Team:

The first aid team of facility is responsible for the following:

 Set up a First Aid Station.

 Triage the injured and provide first aid.
 Coordinate the transportation of the injured either to the First Aid Station, or from the
Station to available hospitals or clinics.
 Create a large "First Aid" sign to identify the site of "First Aid Box".
 Identify medical facilities and pharmacies in the neighborhood". Make a list to post them.
 "Take a first aid class" and give this training sessions to all the employees of the project.
 "Select a cool, shady site", perhaps a shed that is out of sight and away from recovery
activities.

6) Fire Fighting Team:

The firefighting team of facility is responsible for the following:

 Provide coordination, technical assistance, and/or resources to detect and suppress fire;
 Assist with the coordination of mutual aid;
 Pre-position of response resources when it is apparent that fire-fighting resources will be
necessary;
 Relocate firefighting resources when it is apparent that they are endangered by the likely
impacts of the emergency situation;
 Support fire investigations, as requested; and
 Address fire prevention and suppression problems (i.e. leaking natural gas, downed power
lines, water flow problems, etc.).

7) Employees

Employees must assume high level of responsibility to work safely and strive for an incident-free
work place:
 Considering the consequences of their acts on their safety and their fellow employees.
 Following all general and job related EHS work procedures and practices.
 Detecting, reporting and correcting unsafe work behaviors and conditions.
 Applying EHS work practices both on and off the job.
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 Making and suggesting enhancement to the jobs at hand to reduce or eliminate the risk or
stresses associated with job performance.
 Reinforcing safe behavior; and
 Working safely and with regards for the environment is a condition for employment and no
employee should ever consciously perform an unsafe act.

4.2.3 Environmental and Safety Trainings

The training will ensure that the all employees under their obligation to exercise due diligence for
environmental matter. Employees in this instance mean all people working in the project area
including contractors and subcontractors.
 Induction course,
 Emergency response program,
 Personnel responsibilities and awareness to emergency services
 Awareness to hazardous material and MSDS
 Familiarization with site environmental controls, and
 Other specific environmental trainings for relevant employees e.g., daily checks to maintain
controls, cleaning up spills, waste minimization.

During training, consideration of following areas of knowledge and experience are essential:

 Appreciation of properties of hazardous substances e.g., flammable, reactive etc., as well as,
levels at which they pose a considerable risk requiring protective measures.
 Knowledge of early-warning indicators, hazard/risk identification and ability to recognize
potentially hazardous situations.
 Acquaintance with engineering controls to evade the incidence of hazardous situations.
 Familiarity with capability and restraints of facility to respond the hazardous emergencies,
ventilating systems, shut off systems, containment strategies and emergency response
measures.
 Awareness of use, repair/ maintenance of emergency response equipment as well as routine
equipment to health and safety monitoring and protection.

4.2.4 Emergency Response Plan:

Emergency may be defined as a sudden event causing or has the potential to cause serious human
injury and/or environmental degradation of large magnitude. The best "cure" for an emergency is, of
course, "prevention". The probable emergency situation can be:
 Serious fire or explosion
 Natural calamity such as heavy rain, flooding, dust storm or earthquake, cyclone, etc.
 Bomb threat or any sabotage / tenorist activity
 Any other incident involving all or large part of the premises and its workers.

Emergency Response Management is provided by a small team of senior managers (the "Control
Committee") who in turn will direct all response activities through the Emergency Action Team.

1) Objectives

The main objective of this plan is to establish the general guidelines for the actions to be taken in the
event of fires, explosion, emergencies, accidents, disasters and sabotage, aimed at minimizing their
effects and consequences, in order to protect the lives of own or third-party personnel present in
facility as well as neighboring factories area.
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2) Risk Management

The management of contingencies at facility is based on:

 Early detection (alarms, smoke detectors, setting off of safety elements);

 Confinement of emergency area.
 Application of the adequate response procedure
 Follow-up and monitoring

3) Evacuation Plan

The following alarm signal(s) will be used to begin evacuation of the facility (check all which applies):

 Bells
 Horns/Sirens
 Verbal (i.e shouting)
 Other (specify)
 Evacuation map is prominently displayed throughout the facility.
Emergency Contacts Phone No.
Ambulance Service Edhi Ambulance (115)
Emergency Service 15
Fire Department 16
Nearest Hospital -

4) Emergency Equipment

The emergency equipment at the facility will be listed and emergency equipment Inventory table will
be completed.
Emergency Equipment Inventory
Equipment Category Equipment Type Location Description
 Protective Aprons/Coats,
Boots, Gloves & Suits
Personal Protective  Face Shields
Equipment, Safety  First Aid Kits
and First Aid  Portable Eye Wash Kits
Equipment  Safety Glasses
 Self- Contained Breathing
Apparatus
 Others

Fire Extinguishing  Fire Alarm and detection

Systems Devices
 Fire Extinguisher Systems
 Other

5) Response Strategy:

Upon the occurrence of the emergency, the Plan will be developed under the following conditions:

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 First Stage: Notification.

 Second Stage: Initial assistance/rescue.
 Third Stage: Response operations.
 Fourth Stage: Evaluation of the Plan and damages.

4.3 RISK ASSESMENT:

The success of the management plan will lie with its implementation. It is necessary to establish an
EHS department and organizing a team with direct responsibility for putting the plan into practice.
This set-up needs to be provided with adequate resources and an office base.

In order to implement EMP successfully during operation of the facility, it is required to detect the
environmental risks associated with the project and to follow mitigation measures, monitoring plan,
administrative control and emergency response procedures accordingly. Training will also be
required at each step and stage of company, also if necessary to change management processes, will
be documented and available to the employees.

4.3.1 Emergency Response Plan:

A) Solid Waste

Solid waste Hazardous and nonhazardous generated from the facility

Hazardous waste: consist of Oil, expired and rejected drugs, compressed and coated tablets waste
generated during compression process, waste of Aluminum Foil and laboratory waste, glass, broken
ampules, broken vials, empty chemical drums and medical waste from First aid.

Non-Hazardous solid waste: mainly consists of rejected packing material, filters, paper, and card
board sheets. Waste is handed over to waste contractor for disposal.

Solid waste from facility can also cause soil and ground water contamination and pose risk of spill
and hazards of fire.

The solid waste is collected in waste bins and disposed-off through solid waste disposal contractor.

Mitigation

 Segregation of hazardous and non-hazardous wastes and proper storage and disposal of the
wastes is to be ensured.
 A complete inventory of wastes is to be maintained and measures undertaken to reduce,
reuse, and recycle wastes.
 The waste storage area is to be inspected regularly for housekeeping and fire/spillage
protection measures.
 Hazardous waste should be handed over to EPA APPROVED WASTE CONTRACTOR

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B) Liquid Waste

Domestic and process wastewater will be generated during operational phase. The wastewater can
be a potential source of pollution to surface and ground water resources of the area.

Mitigation

 Domestic waste water will be routed into the existing municipal drain.
 Retain effluent prior to final discharge for treatment unless the quality remains within SEQS.
 Water conservation strategies will be employed to avoid wastage of water.

C) Air Emissions

Main source of Air Emissions at facility are one Gas flied and diesel fired generators and boiler. Stack
emission monitoring of Generators was conducted by EPA approved laboratory.

Mitigation

PPEs shall be provided to worker at all potential sources.

 Maintenance of equipment's will be done on regular basis.

 The air emissions will be monitored for the specified parameters on Quarterly basis and
results will be submitted to SEPA as per the SMART Rules.

D) Green House Gases (GHG) Emissions

Green House Gases (GHG) originates from following main sources i.e. vehicles, refrigerators and Air
Conditioner (AC).

Electricity used in the facility is indirect source for the generation of GHG emissions.

Transportation used in the facility is also an indirect source of Green House Gas emissions.

Mitigation
 Air Emissions will be regularly monitored and strictly maintained within the SEQS limits.
 Vehicles used for the transportation would be properly tuned and maintained. The records
for maintenance will be maintained.
 The lighting, equipment's and machines operating in the facility would be switched off
during the lunch and Namaz breaks in order to cut down the indirect source of GHG
emissions.

4.3.2 Noise Exposure

Employees are exposed to different noise levels at different areas of the facility. High noise areas
within the facility are generator rooms

Exposure to high noise leads to Noise Induced Hearing Loss.

Mitigation
 Regular maintenance of machines is to be carried out. Noise reduction options will be
examined by enclosing machines and isolating the operators from the high noise areas.
 Noise mapping of areas will be carried out to identify the high noise areas.
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 Hearing conservation training will be provided to employees and use of hearing protection
will be mandated in high noise areas.
 PPEs should be provided to workers exposed to high noise.

4.3.3 Occupational Health and Safety

The principal hazard generally associated with the point of operation is inappropriate postures;
workers were subjected to high risk of musculoskeletal disorder (MSD). Due to wet surface slipping
risk may arise while in order to reduce Risk associated with wet surfaces Safety Shoes are provided.
Over exertion, ergonomic injuries and illnesses could be the causes of injuries.

Mitigation
 In order to reduce the chance of having musculoskeletal disorder (MSD), it is suggested to
provide health and safety training for both employers and employees so to increase their
awareness of occupational safety and health, encouraging workers to adopt correct lifting
posture when performing job tasks and employers to exercise safety practice.
 If the materials are close to workers, they could easily reach and pick up the materials during
the soiling process, and hence minimizing twisting of their backs and the need of moving
their lower arms across the midlines of their bodies.
 It is known that the most effective way to reduce noise level and prevent noise-induced
hearing loss is to remove the hazardous noise from the workplace or to remove the worker
from the hazardous noise.
 It is advised to increase the distance between the noise source and workers (or working
area) in order to lower the exposure level.
 Another method was to provide hearing protection gears. Considering the reluctance of
workers to wear hearing protectors, individual training to workers in the selection, fitting,
use, repair and replacement of the hearing protectors should be provided.
 For thermal condition, to deal with thermal stress, companies were encouraged to install
ventilation system to increase the air movement or introduce rest pause to workers.

4.4 MITIGATION PLAN:

Pollution prevention and risk management strategies aimed to eliminate, reduce, and minimize
emissions and contaminations that help in safe guarding the ecosystems and promote the health of
natural communities, that is why preventive measures will be taken into account during operation.

Concerned persons are responsible to work on the mitigation and frequencies as mentioned in
Mitigation Matrix, Table 4.1. Facility will be required to hold on these alleviation measures
throughout its operations.

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Table 4.1 Mitigation Matrix

Sr Aspects Impacts Mitigation Measures Responsibility Monitoring
No Frequency
01 Site Location Health & Hygiene issue to None, Dedicated industrial area
communities
PPEs shall be provided to worker at all potential
sources.
Environmental Pollution Maintenance of equipment will be done on
from emissions of regular basis. Manager System and As per preventive
02 Air Emission transportation vehicle, Power The air emissions will be monitored for the Compliance maintenance plan
generator and boiler specified parameters on Quarterly basis and
result will be submitted to SEPA as per the
SMART Rules.

Segregation of hazardous and non-hazardous

waste and proper storage and disposal of the
waste is to be ensured.
Fire hazard, soil and ground A Complete inventory of waste is to be Manager System and On Going
03 Solid Waste water contamination maintained and measures undertaken to reduce, Compliance
reuse, and recycle wastes.
The waste storage area is to be inspected
regularly for housekeeping and fire/spillage
protection measures
Hazardous waste should be handed over to EPA
approved waste contactor.

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Table 4.1 Mitigation Matrix

Sr Aspects Impacts Mitigation Measures Responsibility Monitoring
No Frequency
Storm water runoff and spill controls would be
implemented during operational activities.
The waste water generated from cleaning Cn be
Liquid waste should be a reused after sedimentation tanks. Manager Systems On Going
04 Waste Water source of pollution to land The treated effluent is to be monitored for the and Compliance
and water receiving bodies specific parameters on Quarterly basis and
results will be reported to SEPA as per the
SMART Rules, 2014.
Regular maintenance of machines is to be
carried out. Noise reduction options will be
examined by enclosing machines and isolating
the operators from the high noise areas.
05 Noise Noise pollution, noise Noise mapping of areas will be carried out to Manager System and On Going
induced hearing loss identify the high noise areas. Compliance
Hearing conservation training will be provided
to employees and use of hearing protections will
be mandated in high noise areas.
PPEs should be provided to workers exposed to
high noise.
Health surveillance of workers exposed to
hazardous chemicals and dusts
06 Health, Hygiene Injury, Illness Investigation of incidents Manager System and As per health
and Safety Adoption of safe working practices Compliance surveillance plan
Use of PPE
Ensure machines are properly guarded

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4.5 ENVIRONMENTAL MONITORING PLAN:

Environmental monitoring program is a vital process of any management plan of the company. This
helps in signaling the potential problems resulting from the operations and provides prompt
implementation on effective corrective measures. Environmental monitoring will be required for the
operational phase. The main objectives of environmental monitoring are:

 To assess the changes in environmental conditions,

 To monitor the effective implementation of mitigation measures,
 Warn significant deteriorations in environmental quality for further preventive action.

In order to meet the above objectives the following parameters need to be monitored:
 Occupational Health and Safety
 Air Quality
 Wastewater
 Ground water quality
 Soil Conservation

A monitoring program for the above areas is given in Table 4.2 with the frequencies to conduct
monitoring and responsible authorities to conduct monitoring.

i) Occupational Health and Safety

 Risk involving in pharmaceutical manufacturing are Slipping, fire, spills etc.
 Fire hydrant facility shall be nearby i.e. firefighting tank should be provided and
approachable to all areas for firefighting.
 Emergency Exits to be kept free of obstructions and emergency exit signs to be provided.
 Evacuation plan to be displayed in all areas.
 Trained fire fighters shall be available at all times.
 First aid services already exist in the premises of the plant.
 Ear Muffs/plugs to be provided to personnel working in high noise areas.
 Regular Occupational Health Surveillance of workers handling hazardous chemicals and
working in high noise areas to be conducted.
 All injury/illness and other incidents which are reported will be investigated and corrective
actions taken.

ii) Air Quality

Company will conduct air emissions monitoring of Generators and boiler according to the standards
laid down in SEPA Self-Monitoring & Reponing by Industry Rules, 2014.

iii) Waste Water

Company will conduct wastewater on biannually basis according to SEQS (SMART) Rules, 2014.

iv) Soil Conservation

Soil erosion rates, slope stability of land faces, water sediments load, effectiveness of soil
conservation measures, changes in soil texture and structure will be monitored at frequent intervals.
This study could be done by the EHS department at defined intervals

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S. No Environmental Scope of Monitoring Location Method Frequency of monitoring Responsibility

Aspects Auditing
Ambient Air quality
parameters as
prescribed in SEQS Inside Ambient Air Gas Annually Brookes Pharmaceutical
01 Air Quality Production Area Analyzer
CO, NOx, Sox, PM
2.5, PM 10

Within the
02 Noise Level Operation associated factory premises Noise meter Quarterly Brookes Pharmaceutical
noise levels

Quantity of each Weight or Continuous, Monthly

03 Solid Waste category of waste Within the Volume inventory to be maintained Brookes Pharmaceutical
stored at site and factory premises measurement and report to concerned
disposed through EPA Environmental Officer
Contactors
Record log of water
usage and releases
Effluent treatment Waste Effluent sampling Quarterly Brookes Pharmaceutical
04 Waste Water plant efficiency Generation and lab analysis
checked against the report
parameters prescribed
in SEQS

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4.6 ENVIRONMENTAL MONITORING PLAN:

For effective monitoring, management and documentation of the environmental performance
during the operation, the Environment, Health and Safety (EHS) matters will be discussed during
daily meetings held on site. Environmental concerns raised during the meetings will be mitigated
after discussions between the Engineering Manager and EHS Officer.

4.6.1 Environmental Compliance

The management will be responsible for the regular audit and review of the environmental
management plan. This will include both on-site auditing and review of performance reports.
Additional onsite inspections and investigations will be undertaken in the event of significant
environmental incidents.

The management will participate in the audits and inspections and investigations. The management
will also be responsible for regular review of the environmental performance of the site and site
personnel, and for the reporting on the implementation of commitments made in the EMP.
In particular, there will be:

 Periodic audit reports.

 A review and improvement of the EMP.

4.6.2 Maintenance of EMP

EMP needs to be revised on timely basis to keep up-to-date as per the requirements comes up
regularly. Therefore, outlining the responsibilities and activities associated with the maintenance of
the EMP is essential. EMP revision procedures must include requirements for notification of the
appropriate government and municipal agencies so that their role is also played in the overall
management process.

4.7 CONCLUSION:
The EMP has covered all important aspects pertaining to the operations of the facility and provides
mitigation and control measures to contain any impact expected to arise within acceptable limits. It
also identifies key players of the EMP who will have responsibilities to be executed during facility
operations. Facility will adhere to the EMP during the entire course of its operations and will ensure
that all practices with inherent environmental protection characteristics are being adopted by the
staff.

It is recommended that the EMP will be approved with the assurance that the EMP is followed in
letter and spirit by Brookes Pharmaceutical such that its operations do not pose any adverse impacts
on the environment.

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