This report elucidates Health & Safety inspection of the manufacturing area, solvent room,

mechanical workshop and utility area of Getz Pharma (Pvt.) Ltd. (hereinafter referred as
GPPL), Site inspection was conducted on January 03, 2014 from 900 to 1700 hours at
GPPL facility located in Korangi Industrial Area (KIA), Karachi, Sindh, Pakistan.
GPPL is the largest branded generic pharmaceutical company in Pakistan with its head
office in Dubai, UAE. The complete facility of GPPL is expanding over the 4 acre plot which
mainly comprises of manufacturing block, raw material & finished goods warehouses,
solvent room, head office buildings, engineering and utilities. Manufacturing area comprises
of Oral Solid Dosages (OSD) such as tablets, capsules, Sterile and Penicillin production.
Main Utilities include Boilers, Air Handling Units (AHUs), Purified Water Plant (PWP),
Reverse Osmosis (RO) Plant, Engineering Warehouse and Mechanical Workshops.
Management provided reasonably good welfare facilities to maintain well being of its
employees, these include gym, emergency health care centre, cafeteria, training halls,
auditorium, baby day care centre, mosque and recreational areas. The other allied facilities
include basement car parking, emergency command centre and scrap yard.
Currently, more than 1,500 people are working in different functional areas such as Plant
Operations, Engineering, Projects, Engineering, EHS, Supply Chain, HR, Admin, IT and
Security – making GPPL one of the largest pharma companies in term of human resources.
There are about 600-650 permanent staff rest are on contract basis; these are mostly
workers and supervisors. GPPL operates 300 days a year in two shifts of 12 hours duration
each. Most of the managerial and head office staff observes 9 hour general shift. Overtime
is performed according to production requirements. GPPL produces variety of “Life Saving
Drugs” in hepatalogy, gastroenterology, diabetology, cardiology and infertility and major
brands include Risek, Levofloxacin, Lipiget, Nexum, Ribazole etc.
The leadership of GPPL is highly committed towards maintaining high standards in Quality,
Environmental
& Health & Safety and continuously striving for continual improvement and achieving legal
compliance. GPPL is compliant with cGMP standards and has certification in Quality
Management System (QMS) ISO
9001, Environmental Management System (EMS) ISO 14001 and striving to achieve
OHSAS 18001 by mid of 2014. Moreover, GPPL is the winner of the “Annual Landscaping
Competition” for last three years
and looking forward to receive Golden Award this year.
This report mainly focuses on manufacturing area where various tablets manufacturing &
packaging machines like granulation, dryer, blender, compression, coating packaging and
automatic cartoners are installed for product development; The solvent room located away
from main stream manufacturing block, purpose built for storage of production solvents; The
mechanical workshop comprises of lathe machine, wielding plant, CNC machine, grinder,
sander etc.; and the utility area where boiler, chiller, cooling tower, generator and AHUs are
installed. Therefore the inspection excludes the Health & Safety findings pertaining to
administration office, allied and other welfare facilities.APPENDIX 5
INTERNATIONAL GENERAL CERTIFICATE (2011 specification) UNIT IGC3 –
THE HEALTH AND SAFETY PRACTICAL APPLICAITON
Student number 00216199
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01 /14
Executive Summary
It was an immense learning experience to conduct Health & Safety inspection at the state-
of-the-art pharmaceutical manufacturing facility operating in the full swing and to observe
the complex interaction of Quality, Environmental, Health & Safety Management Systems
from such close. The management of GPPL is committed towards providing safe work place
with all welfare and social facilities, adequate both in terms of quality and quantity. Few
highlights of the welfare facilities provided to all without discretion are; provision of safe
drinking water, state-of-the-art gym, emergency health centre, auditorium, training halls,
baby day care centre, subsidized food and executive dine in facility and recreational area
shows management dedication towards its employees.
Incident/ accident record shows that there have been no serious accident has occurred
during last five year. However, there have been several minor ones. The inspection
identified various potential health & safety risk which pose serious threats to human life,
property, plant and equipment. Focusing on these will not only improve the overall HSE
performance of the GPPL and support organizational endeavor to achieve OHSAS 18001
but also satisfy many international standards and conventions such as the Guidelines on
Occupational Safety and Health Management System (ILO-OSH 2001); the ILO
Occupational Safety and Health Convention (C155) and Recommendation (R164).
The most serious concern is related to incompatible solvents stored at solvent room which
are stacked without adequate segregation. In case of any unfortunate event “Fire &
Explosion” might occur this may cause serious injuries to plant workers, loss of life and
damage to property. Other areas of concerns are illnesses due to presence of chemicals
fumes; in adequate handling of hazardous chemicals; manual lifting of heavy loads;
maintenance related health & safety aspects; electric hazards; noise induced hearing
impairment; slipping and tripping hazards.
Risks associated with the aforementioned hazards out-weight the cost in term of resources,
time and money required to rectify these risks. Failure in managing these risks would lead in
deterioration in Health
& Safety culture and as a consequence moral and motivation of workforce will be tainted.
Repercussion of
dilapidated moral would result in work base illness and injuries, sickness absenteeism,
production loss and other indirect cost to the company. Moreover it is the moral, legal and
social responsibility of the employer
to provide safe place or work, safe plant & equipment and safe system of work.
These improvements will cost the company not more than 1-1.5 million PKR, however in
case of negligence the resulting incident will cost organization in millions in term of bad
market reputation, loss of stock value and business. However, adopting these improvement
will not only improve Health & Safety performance of the company but also facilitate the
smooth OHSAS 18001 certification. In addition, positive health and safety culture will be

promoted throughout the organization. APPENDIX 5 INTERNATIONAL GENERAL

CERTIFICATE (2011 specification) UNIT IGC3 – THE HEALTH AND SAFETY
PRACTICAL APPLICAITON
Student number 00216199
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01/ 14
Main findings of the inspection
It was identified during the inspection that the GPPL is striving hard to achieve OHSAS
18001 certification and some very good practices were observed. The effective
maintenance of fire extinguishers and first boxes, displaying of HSE Policy Statement and
maintenance of adequate LUX level throughout working areas are few examples. However,
there are number of HSE risks identified during the inspection which need serious
consideration of the management. Some of the main findings of the inspection are listed
below:
1) Observation # 1 : Risk of Respiratory Illness at Dispensing Area:
Dispensing area serve as the backbone for pharmaceutical manufacturing company.
Several raw materials and chemicals such as Active Pharmaceutical Ingredients (API),
Excepients and Solvents are transferred from the warehouse to the dispensing area as
identified in the pick list. Where raw material batches are developed after weighing as per
the recipe and dispensed to production for manufacturing.
It was observed during the inspection that dichloromethane (solvent) was being transferred
from the barrel (200 L) to plastic bags through mugs as a part of dispensing process.
Intense fumes of the solvent were felt in the area and workers in the area are exposed to
these fumes almost daily for 12 hours which is serious concern and generally do not use
any protective equipment. Laminar airflow is installed but this is valid for raw materials dust
only. Acute health effects of dichloromethane are eyes and throat irritation, however long
term exposure may lead to chest pain and respiratory illnesses.
Presence of health hazardous fumes in the work place is a clear violation of law. ILO
convention C148: working Environment (Air, Pollution, Noise and Vibration) and (R156);
C170: Safety of Chemicals at Work, (R172) and Sindh Factories Rules, 1975 of Pakistan
that provides clear references to control health hazardous fumes in occupational areas.
It is recommended that management should provide Full face RPE to all workers involve in
dispensing activity as per Material Safety Data Sheet (MSDS) of dichloromethane and no
one should be allowed in the area without RPE and should display mandatory signs (wear
respiratory protection) as an immediate measure. However, providing RPE will not solve the
issue completely as hazard (fumes) will remain there. For controlling the problem holistically
it is suggested that a glass cabin with explosion proofed Local Exhaust Ventilation (LEV)
should be installed within dispensing area and weighing of the solvent will be done under
this area. Accordingly, SOP of dispensing will be developed and training of SOP will be
provided to all concern workers and monitor effectiveness.
The cost for the installation of the glass cabin along with the explosion proofed LEV system
will be around PKR 150,000/- only and logistic arrangements for in-house training will not
cost more than PKR 5,000/-. This cost is quite considerable in comparison to the cost to
company would bear in term of fines, medical treatment and loss of business in term of bad
market reputation.APPENDIX 5 INTERNATIONAL GENERAL CERTIFICATE
(2011 specification) UNIT IGC3 – THE HEALTH AND SAFETY PRACTICAL
APPLICAITON
Student number 00216199
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01/ 14
2) Observation # 6 : Risk of Electric Shock/ Burns/ Scald or Fatality at Purified Water
Plant:
It was noted at the Purified Water Plant (PWP) that condensate water is dripping over the
main electrical panel of the PWP from the faulty steam trap which is installed at steam feed
line to the plant, located right above the electrical panel.
This may cause electrocution to the plant operator or whosoever comes in close contact
which may lead to serious burns/ scald or even fatality. It is not safe for the operator or
anyone whosoever comes in close contact with the plant. It is a clear breach of ILO
Convention C155: Occupational Safety & Health and (R164), 1981 which are concerned
with Safety and Health of employees at work place and Pakistan Federal Law, The
Electrical Act, 1910 which state the Electrical Safety in the factories. In case of any fatal
incident company need to pay hefty fines to the enforcement agency any there may be a
chance that someone from the management may imprisoned which could directly affect the
reputation and business of the company in both national and international context.
Considering the aforementioned risk it is highly recommended that activity should
immediately be restricted and power source should be isolated and maintenance lead would
be informed about the issue. As a precautionary measure it is suggested to change the
location of the steam trap away from the electrical panel. This will cost company note more
than PKR 25,000/- (inclusive of equipment and installation cost).
3) Observation # 16 : Risk of Spinal Injuries from Manual Handling at Solvent Room:
It was observed during the inspection that solvent room workers are manually shifting the
solvent barrels unloaded near solvent room to the pallets placed there. Each barrel contains
200 liters of solvent by volume and weights more than 250 kg. The task include repetitive
movements, lifting of heavy load to the pallet height, frequent twisting and stooping which
could lead to back muscle strain, ligament damage, disk injury or/ and WRULD to the
worker dealing with solvents barrel. The load which worker were dealing is excessive to the
safe load limit as specified in the Pakistan Factories Act, 1934 and it is against the ILO
regulations C155: Occupational Safety & Health Convention, Article (1) & (2) which require
to provide safe working environment to workers at workplaces and to remove health
concerns and hazards.
Manual handling and the associated hazards would be controlled considerably by the
provision of barrel truck for barrel shifting. Further, training of workers can be done on safe
use of the truck to minimize the hazard associate with truck. The cost of barrel truck would
be around PKR 25,000/- and for arranging training internally not more than PKR 5,000/-
which include cost of logistics. APPENDIX 5 INTERNATIONAL GENERAL
CERTIFICATE (2011 specification) UNIT IGC3 – THE HEALTH AND SAFETY
PRACTICAL APPLICAITON
Student number 00216199
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01/ 14
Main findings of the inspection
4) Observation # 18 : Risk of Fire & Explosion at Solvent Room:
It was observed at the solvent room that incompatible chemicals such as Methyl Ethyl
Ketone (MEK), Isopropyl Alcohol and Dichloromethane are stacked together without any
segregation. The chemical containers are sealed however, accidental mixing of
incompatible chemicals in case of container leak would result in major “Fire and Explosion”
as more than 12 barrels, each containing 200 L of solvents are stored in the solvent room.
This could result in loss of life and serious damage to property and equipment.
It is suggested that all chemicals are immediately placed separately on the pallets
(dedicated to each type of solvent). Adequate chemical segregation should be designed by
referring Material Safety Data Sheet and Chemical Compatibility Chart. In addition, dedicate
Stainless Steel (SS) containment trays should be provided to each type of solvent to contain
accidental spills. Moreover, spill kits should be made available to handle the spills and
training should be given to the concern workers. More importantly, management should
considered reducing the solvent stock and store as minimum solvent as reasonably
possible.
The cost of these initiatives would be PKR 150,000/- only which is far less than anticipated
loss to company in term of fatalities and damage to the property or equipment.
Ref: ILO Convention C170: Safety in the use of Chemicals at Work and R172.
5) Observation # 22 : Risk of Contact Injuries on Lathe Machine at Workshop:
During the visit of the workshop it was observed that the worker was working at the Lathe
machine and the guard was removed. It was identified through interview that the guard was
removed during maintenance and was not placed back to its position. The lathe machine
without guard can cause contact injuries mostly due to drawing-in, entanglement and
abrasion which could lead to serious injuries or even a disability can occur.
The situation is a violation of ILO Occupational Safety & Health Convention (C155), Article
16(1) which requires ensuring safe workplace and the Factories Act of Pakistan that clearly
defines the need of machine guarding at factories.
In this case it is advisable to immediately place the guard of the machine and report the
near miss to initiate investigation to identify “immediate” and “Underlying” Causes.
Moreover, an interlock device can be connected with the fixed guard which stop machine
automatically when the guard will be removed. Installation of the “Interlocking Device” would
cost PKR 10,000/- only which is negligible when compared with direct and indirect cost
factors incurred in case of injury or disability.
6) Observation # 31 : Risk of Work Induced Hearing Impairment at Technical Area:
It was noted that at technical area where AHUs and other noise emitting equipment are
installed, operators and support staff is sitting without any cabin and did not wearing ear
defenders for protection and generally exposed to high noise level (>95 dBA) for 12 hour
shift, each day. This would cause work induced hearing loss or impairment to operator and
support staff.
The said issue is directly concern with the ILO convention C148: Working Environment (Air,
Pollution, Noise and Vibration) and Recommendation (R156) which enforce employer to
either control noise at workplace or protect workers from its harmful effects.
It is recommended to provide adequate quality Ear defenders to all available in the area on
immediate basis. A detailed noise assessment can be conducted to identify whether noise
can be controlled at source or at recipient level. Develop isolation (acoustic heaven) to
protect workers from harmful effects of noise. Further, information, instructions and trainings
should be conducted to raise awareness among workers and effectiveness can be
monitored in the safety inspections. The cost of development of glass cabin would be PKR
130,000/- and for training and sign posting PKR 8,000/-.
7) Observation # 34 : Risk of Legionnaire’s Disease from Cooling Towers:
It was identified during the inspection conducted at utility area that the enclosure is not
provided to control spread of aerosol being generated from the showering of water and
these aerosol are dispersing with the wind throughout the area. There is potential that the
aerosol may contains Legionella Bacteria that could cause Legionnaire’s disease to workers
present in the nearby areas. This issue particularly addresses in ILO R97: Protection of
Workers’ Health Recommendation and R31: List of Occupational Diseases
Recommendation, 2002.
The health risk associate with Legionella bacteria can be considerably reduced by effective
biocide dosing in the cooling water and providing the louver type enclosure around the
cooling tower to prevent spread of aerosol in the ambient without affecting the efficient
working of the cooling tower. The cost of the provision of the enclosure will be PKR
155,000/- only which easily out-weight the cost to the company in term of medical/
insurance claims and increased insurance premium.APPENDIX 5 INTERNATIONAL
GENERAL CERTIFICATE (2011 specification) UNIT IGC3 – THE HEALTH AND
SAFETY PRACTICAL APPLICAITON
Student number 00216199
Location Getz Pharma (Pvt.) Ltd. Date of review 04 / 01 / 14
Conclusions
It is appreciated that management of GPPL provide high level of welfare facilities and
working environment to maintain the well being of its employees at work place. The
endeavor of the company in achieving the OHSAS 18001 certification was also noticed
during the inspection. However, a number of Health & Safety related issues are identified
during the inspection and are listed in the recommendations section on this report which
needs immediate attention of the management.
The fumes of dichloromethane can cause serious health concerns to the worker exposed to
them at dispensing area. Condensate water dripping at main electrical panel of the PW
plant can cause electric shock to whosoever may come in contact. The manual handling
was observed by the workers at solvent room without any handling aid can cause spinal
injuries. Contact injuries can occur at lathe machine as guard was not in place during
working at machine. High noise levels at technical floor can cause work induced hearing
impairment as operator and support staff not wearing any ear protection and exposed to the
noise for the 12 hours each day. The potential of Legionnaire’s disease due to possible
presence of Legionella Bacteria in the aerosol of cooling tower. The most significant of all is
the fire and explosion risk at solvent room due to improper chemical segregation which can
lead to loss of life, damage to property and equipment.
Aforementioned issues can cause significant health & safety risk to human life, property and
equipment and therefore required immediate attention of the management. Moreover, these
could pose critical impediment in meeting management vision of achieving OHSAS 18001
certification. In addition, these findings are the clear breach of both National and
International regulations such as the Factories Act of Pakistan, the main ILO Convention
(C155) Occupation Safety & Health, Recommendation (R164) which could lead to
enforcement action against company that could affect the market reputation and morale of
the workers and management alike.
It is recommended to implement the proposed recommendation as per the mentioned
timelines to avoid the worst consequences. It should be noted that most of the
recommendation are low in terms of time, effort and money and out-weight the cost to
company in case of injury, ill-health and prosecution. Implementation of these
recommendations would lead to prominent improvement in the Health & Safety at the GPPL
and reduce the risk of injury, ill-heath and enforcement action.
The implementation of the said recommendation has clearly established morale, legal and financial
justification as a result of increased workforce morale which results in an increased productivity and
profitability.