design ems for pharma labs

8/7/2019 Design EMS for Pharma labs

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2011

Environmental Management

System- Pharma LABS LTD.(Pharmaceutical & Food Analysis)

Submitted By:-

Eshan Gupta (1065)

Gautam Kr Gulshan (1066)

Sampath Gelam (1082)Sandeep Goel (1083)

Shubham Kumar (1086)


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1. About the OrganisationXYZ is a contract testing and analysis laboratory based in ABC, India. We analyze, for our clients, or as a

regulatory requirement, pharmaceuticals, food and agricultural products, construction materials, chemicals

etc. We also help industries in their research processes. Our environment consultancy division helps firms in

keeping the environment clean and free from pollution.

As an independent drug analysis it does not just help pharmaceutical companies to release the drug to the

market and meet FDA norms - it also helps save lives. As a food products' analysis provider, it provides

valuable source of data to government bodies in preventing adulteration - it also helps create consumer

awareness. For example analysis of Cement and Building materials not only helps the civil engineers in

building new structures - it helps a nation to develop its infrastructure. Similarly, XYZ design Industrial

Effluent Systems, and they are not just helping industries to meet PCB norms - they help make tomorrow a

more livable place.

2. Environmental Policy

1. Complianceo We will comply with all applicable environmental laws and regulations.o We will implement programmes and procedures to assure compliance.o Where existing laws and regulations are not adequate to ensure protection of the

environment, we will establish and meet our own environmental quality standards.

2. Preventiono We will implement management systems and procedures designed to prevent activities and /

or conditions that pose a threat to the environment.

o We will strive to prevent release of harmful pollutants to the atmosphere, land or water.o We will minimize the amount and toxicity of waste generated and ensure the safe treatment

and disposal of waste.

3. Continual Improvemento We will continually seek opportunities to improve our adherence to these principles, and will

periodically report progress to our clients in the Laboratory's annual report.

4. Communicationo We will communicate in the Laboratory's annual report our commitment to environmental

quality to our staff and clients.

o We will solicit their input in meeting our environmental goals and in turn offer assistance tomeet their goals.


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3. Environmental Aspects3.1 Environmental impacts and risks

The major environmental impacts from processes carried out by the pharmaceutical industry stemfrom the use of solvents as reaction media and as aids for separation and purification processes.

The solvents may be emitted directly into the atmosphere as VOCs (Volatile Organic Compounds),

or may appear in wastewater. Sources of the latter include solvent residues from separative

operations involving both water and solvent phase, as well as solvents captured in wet scrubbers.

A secondary impact from pharmaceutical operations is dusts generated by grinding and polishingoperations

3.2Various Environmental AspectsSome of the environmental impacts associated with regular laboratory operations are listed below:

Water Pollution

The food and drug laboratories use a wide range of chemicals, disinfectants and sample drugs.

Direct release, without treatment and segregation of any of these chemicals and hazardous wastes to

the drain without treatment can contaminate and corrode the waste water system and create health

risks for the general public, directly or indirectly. Such pollution is also detrimental to aquatic life

and the marine environment.

Air Pollution

The operation of laboratories may result in a number of hazardous emissions to the air from fume

hoods and vents, sterilization / disinfection technologies; plant operations (boilers and generators),

refrigerants (Ozone depleting substances) and treatment technologies (incinerators, if any). Open and

incomplete burning of wastes can create hazardous air emissions such as dioxins

Soil Contamination

The disposal of untreated and un-segregated solid waste (containing organic, degradable mixed

with hazardous chemicals) can result in contamination of the soil and the solid waste system.

Handling & Disposal of Chemicals and hazardous wastes

Improper handling of hazardous chemicals is a health hazard for the laboratory workers and its

indiscriminate disposal can have environmental risks as detailed above. The same applies for other

substances, such as untreated and expired drugs, treated samples of food and drugs and sharps

(needles, syringes, broken laboratory glassware etc).


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Rag-pickers, whose livelihood is dependent on the facility are also at risk though infection and

injury. Indiscriminate dumping of wastes can also result in illegal and dangerous recycling of

chemicals, sharps and other substances, which can become a public health hazard.

Poor drainage and infrequent collection resulting in decomposition of wastes around the facility can

encourage breeding of mosquitoes, flies, rats and other scavengers.

4. Legal RequirementsEnvironmental legality

1 Water (Prevention and

Control of pollution)

Act 1974

CPCB Prohibits the discharge of

pollutants into water

bodies beyond a given

standard, and lays down

penalties for non-compliance

Applicable

2 Water (Prevention and

Control of Pollution)

Cess Act, 1977

SPCB Provides for a levy and

collection of a cess on

water consumed by

industries and local

authorities

Applicable

3 Forest (Conservation)

Act 1980, Forest

Conservation Rules,1981

MoEF, Forest

Department

Restrictions on

conversions of Forest

for uses other than

reforestation,

including use for roads

Not

Applicable

4 Air (Prevention and

Control

of Pollution) Act, 1981

CPCB Provides means for the

control and

abatement of air pollution.

Applicable

5 The Air (Prevention

and Control of

Pollution) Rules, 1982

CPCB Defined the procedures for

conducting meetings of the

boards, the powers of the

presiding officers,decision-making etc

Applicable

6 Environment

(Protection) Act 1986

(EPA) followed by

amendment in

May1994 (Schedule-I)

Ministry of

Environment

and Forests

(MoEF)

Ensure that appropriate

measures are taken to

conserve and protect the

environment before

commencement of

operations.

Applicable

7 Environmental Impact

AssessmentNotification no. S.O.

60 (E) 1994,

Under its ambit, 32 types

of industries are liable toopt for Environmental

clearance from MoEF, by

providing adequate EIA

Applicable


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report

8 The Environment

(Protection) Rules,

1986

Lay down the procedures

for setting standards of

emission or discharge of

environmental pollutants

Applicable

9 The Hazardous Wastes

management(Management and

Handling) Rules, 1989

Procedure for inventory,

control, handling anddisposal of hazardous

waste. Provide for setting

up of disposal sites/landfill

sites design, operation and

closure

Applicable

10 Bio Medical Waste

(Management &

Handling) Rules, 1998

Provide for collection,

segregation,storage,

treatment and disposal of

biomedical wastes

according to the

standards and procedures

Not

Applicable

5.Objectives and TargetTransparency

Target: 100 percent of manufacturing and research and development facilities will provide facility- or

company-specific environmental sustainability information to the public.

Water Cleanliness & Usage

Objective: 1. To reduce kLD (Thousands of Level Detectors) level in disposed water by 20% from 2010

level.

2. To reduce the water usage by 10% from 2010 level.Target:

1. Improving the recovery of solvents from disposed water upto 99.5%

2. Establishing and following standard work practices to reduce wastage of water during any process


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Air Quality

Objectives:

1. To reduce the suspended particulate matter in discharged air by 20% from 2010 level.2. To reduce the emission of hazardous gases by 20% from 2010 level.

Target:

1. Implementing the Air Quality program2. To keep all the ventilation systems upgraded and maintained.3. To implement a regular inspection and monitoring program to ensure all devices all working

properly.

4. Reduce air emissions through process change and emission controls by microscale chemistry.5. Establishing a high purity solvent delivery system

Diposal of Hazardous Waste

Objective:

1. To establish a proper hazardous waste disposal systemTarget:

1. Labelling of Hazardous waste2. To fix closed container with lids for hazardous waste collection3. To select the proper site for landfill.

Environmental Literacy

Target: Increase employee awareness and understanding of global environmental issues.100 percent of

facilities have a five-year literacy plan and implement one environmental education campaign each year

from 20062010

Compliance

Target: Zero accidental releases; zero government-issued violations.

Done By:-

Sandeep Goel (Sec-2), 1083


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6. EMS Implementation in Pharmaceutical LaboratoriesLike any other important business activity in a lab, environmental issues must be carefully managed. For

example, important business activities occurring in labs address quality, finance, human resources, or safety

and have appropriate management systems.

The collection of activities undertaken to ensure that environmental issuesare managed is called an

environmental management system (EMS). AnEMS is essential to:

o Consistently comply with environmental laws and regulations;o Improve overall environmental performance;o Address environmental liability from current or past practices;o Maximize the investment, no matter how small, in environmental affairs;o Integrate environmental objectives into overall business objectives; ando Provide for an environmentally safe workplace.

Implementation

o Establish roles and responsibilities and provide resources.o Provide training to employees on their environmentalresponsibilities.o Institute processes for communicating both internal and externalenvironmental management issues.o Develop written procedures and policies and ensure thatdocumentation is maintained.o Identify potential emergencies and develop procedures forprevention and response.

7. Resources, Roles, Responsibility and Authority

Head from each department will be the part of the EMS core team who will make further another team

consisting of subordinates and workers of his team.

Through a common meeting, consisting of all the employees and workers and head of the team who will be

the GM category person (Top Management), will make each person acquainted with the environmental

policy and objectives and targets.

Each department head will take care of the objectives and targets set for his department and in conjugation

with other department will develop new strategies through brain storming.

Using Delphi technique in which experts of different fields like air, water, soil, waste disposal in

pharmaceuticals sector are invited.

Head of the team will be responsible for budget allocation, reviewing the progress and guiding the core team

members of different departments.

Each department head in consultation of team head and the expert from outside will work out the plan and

execute the plan to reduce chances of accidents, looking for all the environmental aspects of that area


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designing the new processes, their implementation and assessing the results and reporting to top

management.

Employees of that department at middle level will be given responsibilities to fill the checklist prepared.

Measuring the effects of changed and improved practices on daily basis. A standard approved checklist will

be maintained by them.

Workers at bottom level who are involved in implementation will be given due importance and their in-

charge have to continually motivate them and let them understood the importance of EMS.

8. Training, Awareness and CompetenceEnvironmental Training

A critical element for the successful implementation of a lab EMS is the development and implementation of

an environmental training program. Employees mayencounter various types of hazardschemical, physical,

biological, radiological etc. Acomprehensive training program provides:

Employees with information to conduct their jobs in a safe manner

A process to assure compliance with regulatory-based training requirements Mechanism which demonstrate managements commitment to improved environmentalPerformance. Communicate corporate environmental policies and goals Elevate the environmental awareness of staff

Done By

Sampath Gelam, Sec 2, 1082


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classroom training.Computer-based training isincreasingly being applied as aneffective teaching method.

9. Communication

For any training program its important to know the way and medium of communication according to the

executives to be trained. The main aim should be delivering a better training program which helps in

uplifting the knowledge base and workforce way of working in the organization, with keeping in mind to

enhance the performance of the executives for the required issue. Even inventing new and better

technological ways are there in scenario but the training program head should know the limits according to

the audience group.

10. Environmental Management System Documentation

In order to be in conformance with this provision of ISO 14001(4.4.4) an organization must be able to

answer the overall question: "What level of documentation is needed?". In order to answer that question

three specific tasks must be addressed under the Environmental Management System Documentation section

of the standard.

The organization must describe the foundation elements of the environmental managementsystem in either paper or electronic format.

The preceding description mustdemonstrate the interaction between the foundation elements of theenvironmentalmanagement system.

The description must reference the related documentation.

The use of the word "document" in ISO 14001 provides a direct reference to whatare the foundation

elements of the environmental management system. Where is theword "document" used in the standard?

For any further the documentation should be in compliance with ISO 14001 and fulfill all the needs for

external and internal auditing.

11. Monitoring of Implementation

Every laboratory must have an environmental health and safety officer (EHSO) to organize different

activities and monitor the implementation of the environmental plan. Routine monitoring would be done by

EHSO at laboratory level. He/she will be responsible for maintaining records as per the agreed protocols. In

addition, two health, safety and environmental surveys would be undertaken (once during mid term another


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before project closure) by a competent independent agency. Environmental audit will be taken up along with

technical audit of the food and drug laboratories. It should have compliance with both food department of

India and health department.

Outputs:

i) Compliance reports/records

ii) Inventory of hazardous material and Material safety data sheets

iii) Audit reports

Done By:-

Eshan Gupta (Sec 2, 1065)


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12 Emergency Preparedness

Spill Containment: The need for spill protection applies to all areas where materials can be potentially

damaging. The following are some steps to prevent spills from entering drains.

Floor drains should be eliminated from new construction. Where floor drains presently exist, they shouldbe covered with properly fitting drain covers. Have spill kits available where required or where spills are likely to enter drains.

Further requirements for emergency preparedness

A communications device or alarm system capable of informing facility personnel and local emergencyresponse authorities in the event of an emergency.

Portable fire extinguishers (including special extinguishers, foam, and dry chemical, necessary for thewaste), spill control equipment, and decontamination equipment.

Water at adequate volume and pressure to supply water hose streams, foam producing equipment, orautomatic sprinklers.

Waste containers must be arranged in the accumulation area so that there is adequate aisle space toallow access for emergency personnel and equipment

The following information must be posted next to the telephone in the area:o Name and phone number of the emergency coordinator, ando Location of the spill control material, fire alarm, and fire extinguishers and telephone number of the

local fire department unless there is a direct alarm.

Done By:-

Gautam Gulshan (Sec-2, 1066)


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13. Non Conformance and corrective and preventive action

Since XYZ is a leading analysis and research group, providing complete solutions for improving quality in

processes, products and services. XYZ provides calibration of production & quality control equipment with

traceability to national / international standards. This means that your equipment are precise and thereforereducing the probability of end-product defects / rejects. More over it caters to a large number of clients with

varied interests. Due to this, there are good chances for non conformance in terms of EMS.

XYZ should have following proper procedures for inquiry and corrective measures:

Determine the cause: Why the non-conformance has occurred ? What are the reasons behind it?Whether it was avoidable in nature? What can be its frequency? Is there any documentation of the

nonconformance or not?

Decide if immediate action is required: If the impact of nonconformance is great and catastrophicthen there is will be immediate need of corrective actions. It should be recognised as early with

proper course of action to deal with it.

Decide which action should be taken: An appropriate set of action is required for dealing with thefull efficiency to the non-conformance occurred. There should be documentation of each of such

incidences in order to have a proper guideline for the approach required.

Check to see if measures are effective:There should be repetitive scrutiny of the non-conformanceand the action taken to judge the extent of the effectiveness of the action and the level of success

achieved in dealing with non-conformance.

Record shortcoming of Corrective Actions: For the purpose of the proper guideline and futurereference there should be proper documentation of the shortcomings and the problems in action on

the event. This will help in research work for dealing with the similar problems more effectively.

Record changes in procedures required to avoid duplication: With the each new non-conformance of similar type there will be change in the approach to it and this should be properly

documented and preventive measurements should also be indicated in order to avoid any duplication

of shortcoming in future.


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14. Records

Records are required to demonstrate compliance with the EMS. Theyre collected within the framework of

the EMS, and they record the extent to which the EMS design is performing. Procedures are developed to

maintain, identify, collect, index, and store records. Included in the records being maintained by the system

are contractor, procurement, audit, management review, and training records necessary for the confirmation

of the EMS. The retention and maintenance of records associated with your EMS serve several purposes.

Primarily, these records are the evidence of an effectively operated EMS. This evidence must be shown to

registrars and auditors to verify that your EMS conforms to the ISO 14001 Standard. Also, these records

may include procedures that have been removed from service which are retained for an operational history

of mothballed equipment or to retain operating expertise for techniques that have been supplanted.

For the purpose of XYZ, as the organization deals with multiple procedures there is a need of recording all

the procedures, events, data and the course of action for it. There should be always some documentation of

the each and every action related to the working in XYZ. Some of the records that should be maintained in

XYZ's EMS which are specific to different fields of working include:

Inspection and monitoring data. Calibration and maintenance records for instrumentation. Non-conformance and corrective actions records and reports. Record of updates in compliances and measures.

Handling, storage and procurement record. Air, Water & hazardous waste discharge record. Non-hazardous solid waste records. Hazardous substance releases record. Radio-active & special waste record. Sustainable practices record.

15 Environmental management system audit

External auditing is recommended for ISO 14001 EMS. Further, EPA requirements for their Self-Policing

Policy, and Star Track Program includes independent auditing. The neutral vision of the auditor is at the

core of this concern. The intent of auditing is to supply management with better vision from which they

make decisions. In-house staff may not be comfortable delivering completely objective information critical

enough to be useful for system modification.

XYZ shall insure that the EMS audits are conducted at an interval of 3 months at least with the objectives of

:


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Determine whether the EMS system conforms the planned arrangements for environmentalarrangement including the requirement of standards and hence been properly implemented and

maintained.

Provide information on the result of audits to management.

Audit programmes of the XYZ shall be planned, established, implemented and maintained by the

organization, taking into consideration the environmental importance of the operations concerned

and the result of previous audits. Audits procedures shall be established, implemented and

maintained that addresses the responsibilities and requirement for planning and conducting audits,

reporting results and retaining associated records and determination of audits criteria, scope,

frequency and methods.

16 Management Review

Top management shall review the XYZs EMS, at interval of 3 months. This interval could be shorten also

if considered necessary. Management review should be done to ensure the XYZs EMS continuing

suitability, adequacy and effectiveness. Reviews shall be used for the enhancing performance to cater the

clients. Reviews shall include accessing opportunities for improvement and the need for changes to the

EMS, including the environmental policies, targets and objectives. Records of management reviews shall be

retained. Since XYZ is into contract testing and analysis so it highly depends of the frequent reviews and

feedbacks.

Input to management reviews shall include.

1. Communication and complaints of the clients and other external bodies.2. Overall performance of the organization.3. Performance in achieving targets and goals.4. Results of internal audits and the evaluation of compliance with legal requirements.5.

Status of corrective and preventive actions.

6. Previous management reviews.7. Feedbacks from the staff directly affected and involved with the operations.8. Recommendation for improvement.9. Changes in the international & national standards.10.Other developments in the legal & political issues.

This review shall contribute to any of the managerial decisions be it be of any kind.

Done By:-

Shubham (Sec2, 1086)

design ems for pharma labs

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